Biomedical subjects

E B Marsolais

Publications and source records attributed to E B Marsolais.

At least 19 recordsLinked to original sources

PubMed2003

Functional electrical stimulation for walking in paraplegia: 17-year follow-up of 2 cases.

OBJECTIVE: To assess the safety and effectiveness of long-term use of functional electrical stimulation (FES) for exercise, standing, and walking in individuals with paraplegia, using percutaneous intramuscular wire electrodes. DESIGN: Case study with more than 17 years of follow-up. SETTING: Institutional rehabilitation practice. STUDY PARTICIPANTS: Two long-term (17 years) volunteer participants with paraplegia who were able to stand and walk using FES. INTERVENTION: Chronically indwelling percutaneous intramuscular wire electrodes connected to a portable microprocessor-controlled stimulator were used to exercise muscles while controlling trunk, hips, knees, and ankles and develop activation patterns to produce standing and walking. MAIN OUTCOME MEASURES: Clinical complications, electrode performance and survival probability, and functional performance. RESULTS: The most noted clinical complications included localized inflammation at the electrode site and superficial infection that responded well to topical and oral antibiotic treatment. The change from coil-wire electrodes, with a survival of 35% after 1 year, to double-helix electrodes improved electrode survival to 80% at 1 year and 48% at 5 years. Maintenance of the multichannel percutaneous FES walking system required replacement of an average of 2 electrodes every 6 months. Participants were able to use their system for independent exercise and standing and for walking with standby assistance. CONCLUSION: Although the FES system was devised as a temporary means of achieving functional activation until permanent means could be achieved, it was found to be effective and relatively safe for more than 17 years. Two long-time users of the system had no adverse effects to their skeletal system. The most common problems were daily care of electrodes at exit sites, frequent irritation of the skin around electrodes, and replacement of failed electrodes. The percutaneous system has the potential for short-term rehabilitation in individuals with incomplete paraplegia or stroke.

Electric Stimulation Therapy↗

PubMed2001

Surgical technique for installing an eight-channel neuroprosthesis for standing.

A standardized surgical procedure to implant an eight-channel functional neuromuscular stimulation system in the lower extremities for standing, exercise, and transfers for individuals with spinal cord injury has been developed. The implanted components include: (1) one eight-channel receiver-stimulator, (2) epimysial electrodes, (3) intramuscular electrodes, and (4) inline connectors. The development process included identifying the target muscle set for electrode placement and the corresponding surgical approaches, determining the stages of the surgical procedure, and assessing the effectiveness and stability of the implanted neuroprosthesis. The bilateral muscle set consists of the vastus lateralis, the gluteus maximus, the semimembranosus, and the erector spinae. Surgical approaches to the nerve entry points were developed through a series of cadaveric studies and intraoperative tests. Electrode placement is related to bony landmarks and based on standard orthopaedic approaches. The components of the neuroprosthesis are installed in one surgical session, with three stages. This procedure has been applied successfully in seven individuals, resulting in strong, isolated stimulated contractions adequate to raise and lower the body, maintain standing with a walker, and perform pivot transfers. The standardized surgical procedure is repeatable and teachable and will be used in upcoming multicenter clinical trials of the implanted neuroprosthesis.

Adult↗

PubMed2001

Percutaneous implantation of iliopsoas for functional neuromuscular stimulation.

Hip flexion is required for walking and stair climbing. Percutaneous electrical stimulation of the iliopsoas muscle is a potentially useful and reliable method of providing hip flexion in individuals who are paralyzed. In this study, groin, lateral abdominal, and paraspinal approaches of percutaneous electrode implantation for electrical stimulation of the iliopsoas muscle are described. The paraspinal approach using stimulation of the second and third lumbar roots gave the best hip flexion response; however, it often was accompanied by unwanted stimulation of the hip adductor and abdominal muscles. Wire breakage and electrode movement were the most common causes for failure of maintaining hip flexion. The paraspinal approach, using double helix electrodes, provided an average of 110 weeks of functional hip flexion sufficient for walking. It is feasible to implant electrodes in the iliopsoas muscle. An open technique for permanent implantation of intramuscular electrodes is being developed to selectively stimulate the iliopsoas, which will extend the range and duration of hip flexion that will allow stair climbing in individuals who are paraplegic.

Adult↗

PubMed2000

Feasibility of gait training for acute stroke patients using FNS with implanted electrodes.

Following stroke, many patients do not regain a normal, safe gait pattern even after receiving conventional physical therapy. One promising technique is functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM). Five subjects were admitted into the study at 3 weeks to 3 months following the stroke. For each subject, electrodes were placed intramuscularly at the motor point of up to seven lower extremity paretic muscles. Subjects were treated for 6 months, twice weekly with FNS-IM for exercise and gait training. The stimulator and software provided individualized stimulation patterns, with flexible stimulus parameters and activation timings of multiple muscles. Outcome measures were active joint movement, coordination (Fugl-Meyer scale), balance (Tinetti scale), gait (Tinetti scale), activities of daily living (functional independence measure), and therapist and subject satisfaction (survey instrument). Subjects tolerated well the placement of IM electrodes with no adverse effects, and subjects lost no conventional rehabilitation time. Therapists and subjects were satisfied with the FNS-IM system as a rehabilitation tool. Post treatment, subjects demonstrated improvements in impairment and disability in active joint movement, coordination, balance, gait and activities of daily living. Considered together with prior research for chronic stroke subjects, this research suggests that FNS-IM can be successfully and efficaciously utilized for gait training for those with acute stroke.

Acute Disease↗

PubMed2000

The Case Western Reserve University hybrid gait orthosis.

Six individuals with paraplegia and injury levels from C-1 through T-12 participated in a study to evaluate the functional capabilities of a hybrid gait orthotic system. Subjects learned to use a custom-built reciprocal gait orthosis without stimulation and with electrical stimulation activating between 4 and 16 muscles. Outcomes were scored with standard physical therapy measures including the Tinetti test, a timed get up and go, Borg rating of perceived exertion, and the Functional Index Measure (FIM). Subjects have successfully accomplished sit to stand, stand to sit, and walking maneuvers measured for time, speed, and distance. Metabolic consumption was measured for walking in the light work region of 5.1 to 6.5 metabolic equivalents (METs) 1 MET = 3.5 ml of O2/kg/min with hybrid gait orthosis. Perceived exertion as measured with the Borg scale indicated that use of the bracing system with functional electrical stimulation was "easier" than without stimulation. Subjects using a hybrid system were able to walk up to 350 m at average speeds of 0.25 m/s. Walking speeds for 30- and 50-meter distances reached 0.45 m/s. Additionally, walking distances with stimulation were 2 times greater than those of non-stimulated reciprocal gait. FIM scores indicated that system users would become slightly more independent in mobility. Results were used to determine the most useful brace modifications for the next generation of Case Western Reserve University hybrid gait orthoses to allow an expanded function that will include stair climbing and side stepping.

Adult↗

PubMed1999

Walking with a hybrid orthosis system.

OBJECTIVE: The purpose of this case study was to determine the functional effectiveness of the hybrid orthosis system (HOS) for sit-to-stand and walking compared with the reciprocal gait orthosis (RGO) alone in a subject with significant orthopedic abnormalities. DESIGN: A subject with complete T7 paraplegia and a 13 cm leg length discrepancy was implanted with 14 intramuscular electrodes and fitted with a custom isocentric RGO. The subject was instructed in the use of the HOS and a two wheeled walker in the home and community settings. MAIN OUTCOME MEASURES: Using the Functional Independence Measure (FIM), and the Borg exertion scale the subject's level of independence and his perceived exertion was determined as well as the safety and efficacy of system use in the community. RESULTS: Results show that the HOS provided safe, independent ambulation with a two wheeled walker and met established criteria for limited community use. Walking in the RGO alone was feasible, however, the addition of functional electrical stimulation (FES) allowed this subject to walk farther and with less perceived exertion. CONCLUSION: This case study suggests that a hybrid orthosis system can be an effective clinical option for individuals with significant orthopedic complications that might otherwise contra-indicate the prescription of either conventional braces or FES alone.

Adult↗

PubMed1999

Implanted functional electrical stimulation system for mobility in paraplegia: a follow-up case report.

A 16-channel functional electrical stimulation (FES) system has been implanted in a person with T10 paraplegia for over a year. The system consists of two eight-channel radio frequency controlled receiver-stimulators delivering stimuli through a network of 14 epimysial and two intramuscular electrodes. Using this system and a walker for support, the subject was able to stand up for 8 min and walk regularly for 20 m. The standing duration was limited by arm fatigue since upper extremities supported an average of 25% of body weight. This was due to suboptimal hip extension and some undesired recruitment of rectus femoris and sartorius with stimulation of quadriceps electrodes. The left quadriceps exhibited rapid fatigue that limited walking distance and duration. The metabolic energy requirements were well within the aerobic limits of the sedentary paraplegic population. At one-year follow-up evaluation all electrodes are functional except one intramuscular electrode. The implant caused no adverse physiological effects and the individual reported health benefits such as increased energy and overall fitness as a result of the FES system use. With further improvements in muscle response through innovative surgical techniques, the 16-channel implanted FES system can be a viable addition to exercise and mobility function in persons with paraplegia.

Adult↗

PubMed1998

Implantation of a 16-channel functional electrical stimulation walking system.

A 16-channel electrical stimulation system was implanted in a 39-year-old patient with T10 paraplegia to restore sit to stand, walking, and exercise functions. System implantation required two surgical sessions. In the first session, the posterior muscle set consisting of bilateral semimembranosus, adductor magnus, and gluteus maximus muscles were exposed and epimysial electrodes sutured at the point of greatest muscle contraction. Closed double helix intramuscular electrodes were implanted in the erector spinae. Two weeks later, epimysial electrodes were attached to the eight anterior muscles consisting of the tibialis anterior, sartorius, tensor fasciae latae, and vastus lateralis with all 16 electrode leads passed to the anterior abdominal wall. The electrodes were connected to two eight-channel stimulators placed in the iliac fossae, and the system was checked by activating the individual muscles. The implanted stimulators received stimulation instructions and power via a radio frequency link to an external control. Stimulation patterns for standing, walking, sitting, and exercise functions were chosen from a preprogrammed menu via a finger key pad. After 3 weeks of restricted patient activity, all electrodes stimulated either the target muscle or had an acceptable spillover pattern. The patient is undergoing a 16-week rehabilitation course of stimulated exercises gradually increasing in intensity. At the conclusion, the goal is to discharge the patient with the system for spontaneous use. Although long term followup is required to determine system reliability, preliminary clinical results indicate that targeted, repeatable, functional muscle contractions in the lower extremity can be achieved with a system consisting of epimysial electrodes.

Adult↗

PubMed1998

Reliability of closed double helix electrode for functional electrical stimulation.

The reliability of a closed double helix electrode in the lower limbs was studied. This electrode is an implanted intramuscular electrode and is used for a totally implantable functional electrical stimulation system. Eighty electrodes were evaluated retrospectively with a mean period of 15 months. The total implant time was 1222 electrode months. The cumulative proportion surviving was 0.934 at 6 months, 0.855 at 1 year, 0.765 at 2 years, and 0.730 after 30 months. Fifteen of 80 electrodes failed, seven showed increasing electrode impedance, and eight had undesirable changes in recruitment. Of the failed electrodes, 2/3 failed during the first 10 months. The reliability was 0.91 at 6 months and 0.80 at 1 year after implantation in all muscle groups. The closed double helix electrode displayed an increased reliability when compared with the open double helix electrode at 6 months, and an equivalent reliability as compared with the electrodes developed by Handa and colleagues at 6 months and 1 year, using the chi squared test for independence. This study suggests that the closed double helix electrode has an acceptable reliability and can be used as a part of a totally implantable functional electrical stimulation system.

Electric Stimulation Therapy↗

PubMed1997

Transforaminal and posterior decompressions of the lumbar spine. A comparative study of stability and intervertebral foramen area.

STUDY DESIGN: Ten fresh, cadaveric, two-vertebrae, functional spinal units were used to study the pathoanatomy, intervertebral foraminal area, and flexibility changes after posterior and transforaminal decompression. OBJECTIVES: To determine the feasibility of an endoscopic transforaminal approach as an alternative to conventional approaches, to establish the adequacy of transforaminal decompression without destabilizing the spine, and to study the structural changes in the spine after decompressions. SUMMARY OF THE BACKGROUND DATA: Posterior decompression entails major dissection and excision of bone and ligaments to access the spinal canal. Posterior decompression may be complicated by acute or chronic spinal instability, and the adequacy of lateral decompression is highly subjective. METHODS: The functional spinal units were mounted in quick-setting epoxy blocks. Pre- and postoperative computed tomography scans were taken to study changes in the foraminal area. Pre- and postoperative flexibility and anatomic studies were performed to compare the results. RESULTS: A 45.5% increase in the intervertebral foraminal area was possible, there was no flexibility change, and minimal anatomic damage to the spine was noted after transforaminal decompression. A 34.2% increase in the intervertebral foraminal area and a significant increase in extension and axial rotation flexibility were noted after the posterior decompression. CONCLUSION: Transforaminal decompression produced a significantly larger increase in the intervertebral foraminal area than posterior decompression, without increasing the range of motion or neutral zone in any direction. Because there was no violation of the anatomic integrity of the spine in the transforaminal approach, the risk of surgically induced instability was minimized. Endoscopic transforaminal decompression is a feasible alternative to current approaches.

Adult↗

PubMed1997

Endoscopic transiliac approach to L5-S1 disc and foramen. A cadaver study.

STUDY DESIGN: The toros of fresh cadavers were used to create endoscopic channels through the iliac wings to gain access to the L5-S1 disc and foramen. The spine and pelvis then were dissected out en bloc, and the anatomic relationships were studied. OBJECTIVES: To determine the feasibility of a transiliac approach to the L5-S1 disc and foramen and to assess the safety of this approach by studying the anatomic relationships of the transiliac track. SUMMARY OF BACKGROUND DATA: Because of its location deep in the pelvis, the L5-S1 disc and foramen are not easily accessible via a supra-iliac portal. A laparoscopic approach violates the abdominal cavity, and makes major vessels and viscera at risk for injury. METHODS: A core drill was inserted over a guide wire into the iliac wing under fluoroscopy to obtain a core of bone, which then was removed to create a transiliac channel. An arthroscope was inserted through the channel to perform discoscopy or foraminoscopy. The spine was dissected out en bloc to study the relationships of the track. RESULTS: It was possible to use a transiliac approach to L5-S1 in all the experiments. There was no damage of neural structures in any of the experiments. CONCLUSIONS: The results of this study suggest that it is possible to access the L5-S1 disc and foramen through the ilium without injuring important structures. It would be necessary to conduct a study based on an animal model and to evaluate the results before using this procedure in a clinical situation.

Adult↗

PubMed1997

Muscle selection and walking performance of multichannel FES systems for ambulation in paraplegia.

A minimal set of muscles (8 to 16) were identified as candidates for implantation in a clinical system to provide walking function to individuals with complete paraplegia using functional electrical stimulation (FES). Three subjects with complete motor and sensory paraplegia had percutaneous intramuscular electrodes implanted in all major muscles controlling the trunk, hips, knees, and ankles. Stimulation patterns for walking with FES were generated for different sets of eight and 16 muscles. The quality and repeatability of the resulting gait produced by walking patterns consisting of various combinations of muscles were determined. Most eight-channel stimulation patterns resulted in scissoring or insufficient hip flexion, preventing forward progression. One eight-channel system allowed a maximum speed of 0.1 m/s with a cadence of 22 steps/min and a stride length less than 0.3 m. Improved walking performance was observed with 16 channels of stimulation. This ranged from slow step- to gait at 0.1 m/s to smooth reciprocal gait at 0.5 m/s. In all three subjects, the favored combination of 16 channels included erector spinae for trunk extension; gluteus maximus, posterior portion of adductor magnus and hamstrings for hip extension; tensor fasciae latae and either sartorius or iliopsoas for hip flexion; vastus lateralis/intermedius for knee extension; and tibialis anterior/peroneous longus for ankle dorsiflexion. In one subject the 16-channel FES system provided repeatable day-to-day gait averaging 0.4 m/s, 58 steps/min and a stride length at 0.8 m. A maximum repeatable walking distance with 16 channels was 34 m. Multiple 34-m trials were possible with minimal rests between walks. Fatigue of both the hip extensors and upper body was a limiting factor. The selection of target muscles for implantation is critical to the performance of FES systems. This study provides guidelines to muscle selection for walking with FES based on objective measures of gait performance. The findings indicate that a 16-channel FES system for total implantation is feasible for repeatable short distance, independent, walker-support walking in paraplegia.

Adult↗

PubMed1996

Implanted Functional Neuromuscular Stimulation systems for individuals with cervical spinal cord injuries: clinical case reports.

OBJECTIVE: To determine the feasibility of providing the ability to stand and to facilitate the performance of standing transfers to individuals with cervical-level spinal cord injuries via functional neuromuscular stimulation (FNS). The applicability of implantable technology to this population was investigated, and the characteristics of the potential system users were explored. The effects of FNS on the effort and assistance required to stand and complete standing transfers were examined. SETTING: Institutional rehabilitation practice. DESIGN: Nonrandomized controlled trial. PATIENTS: Twenty-four individuals with low cervical spinal cord injuries were evaluated for inclusion in a program of lower extremity FNS, four of whom received the intervention. INTERVENTION: Chronically indwelling percutaneous intramuscular electrodes were used to exercise the hip, knee, and trunk extensors and develop activation patterns to produce standing function. These temporary systems were then replaced with silicone-enclosed helical wire electrodes suitable for eventual use with an eight-channel implantable receiver/stimulator. MAIN OUTCOME MEASURES: Full sensory and motor evaluations were performed and physical contraindications to stimulation were catalogued. For active subjects, American Spinal Injury Association Total Motor Scores with and without FNS were recorded, along with quadriceps strength and ability to complete exercise, standing, controlled sitting, and standing transfer maneuvers. Performances of implanted electrodes were determined by the stability of recruitment properties, impedances or surface potentials, and serial radiographs. RESULTS: Motor scores increased an average of nine points with stimulation over baseline volitional values. With FNS, all four volunteers were able to exercise, stand, and sit independently or with minimal assistance. Although they required varying degrees of assistance with the pivot phase of the transfer maneuver, all were able to raise and lower their body weight independently with stimulation and to use the system to facilitate standing transfers. One participant received the implantable receiver/stimulator, which remains operational at follow-up more than 3 years later. CONCLUSION: FNS can provide the ability to exercise, stand, and transfer to individuals with tetraplegia, even in the presence of medical complications and upper extremity impairment. FNS facilitates standing transfers by eliminating the heavy lifting usually required by a caregiver, thus decreasing the effort and assistance necessary to gain access to places impossible to approach with conventional sliding transfers.

Adult↗

PubMed1996

Therapeutic neural effects of electrical stimulation.

The use of a functional neuromuscular stimulation (FNS) device can have therapeutic effects that persist when the device is not in use. Clinicians have reported changes in both voluntary and electrically assisted neuromuscular function and improvements in the condition of soft tissue. Motor recovery has been observed in people with incomplete spinal cord injury, stroke, or traumatic brain injury after the use of motor prostheses. Improvement in voluntary dorsiflexion and overall gait pattern has been reported both in the short term (several hours) and permanently. Electrical stimulation of skin over flexor muscles in the upper limb produced substantial reductions for up to 1 h in the severity of spasticity in brain-injured subjects, as measured by the change in torque generation during ramp-and-hold muscle stretch. There was typically an aggravation of the severity of spasticity when surface stimulation reached intensities sufficient to also excite muscle. Animals were trained to alter the size of the H-reflex to obtain a reward. The plasticity that underlies this operantly conditioned H-reflex change includes changes in the spinal cord itself. Comparable changes appear to occur with acquisition of certain motor skills. Current studies are exploring such changes in humans and animals with spinal cord injuries with the goal of using conditioning methods to assess function after injury and to promote and guide recovery of function. A better understanding of the mechanisms of neural plasticity, achieved through human and animal studies, may help us to design and implement FNS systems that have the potential to produce beneficial changes in the subject's central nervous systems.

Animals↗

PubMed1995

Endoscopic electrode implantation. A new technique in an animal model.

The purpose of this study was 2-fold: (1) to describe a technique of creating an endoscopic interstitial working space; and (2) to describe the technique of implanting the modified double helix and the Huntington cuff electrode in the space created. Two cannulated balloons were inserted on either side of a standard arthroscope, which had been inserted to identify the target branch of the sciatic nerve. Traction was applied on each cannula after inflating the balloons with 3 to 5 cc of saline, to create a cylindrical operating space between them. After mobilizing a segment of the nerve, either of the 2 electrodes was implanted with the aid of special instruments. The results indicate that (a) it is possible to create interstitial operating spaces reliably and consistently; (b) satisfactory hemostasis can be achieved through the tamponade effect of the balloons and endoscopic cautery units; (c) excellent visualization is achievable; and (d) it is possible to implant electrodes in a reproducible manner. The interstitial spaces are portable and can be used for various procedures in most anatomic locations. Modification of the cuff electrode will be necessary to make it easier for endoscopic implantation.

Animals↗

PubMed1994

Endoscopic electrode implantation for enhanced stimulation of the hamstring branches of the sciatic nerve in paralyzed subjects.

Seven hamstring branches of the sciatic nerves in eight posterior thighs of four paraplegics were implanted with electrodes endoscopically. Strong initial responses were obtained in each case on continuous electrical stimulation. Three of the implants were removed immediately due to rapid decay in the response to stimulation; two had muscle power reduced to grade IV and two to grade III over 2-week period postoperatively. We believe the reduction in strength was partly due to hematoma surrounding the electrode and partly due to migration of the electrode away from the target nerves. Further work needs to be done to improve the technique and implant designs to improve results. Due to the excellent visual control it offers, this technique has the potential for accurate implantation of electrodes without massive exposures and its attendant morbidity.

Arthroscopy↗

PubMed1994

Augmentation of transfers for a quadriplegic patient using an implanted FNS system. Case report.

A 22 year old man with incomplete quadriplegia (C6-7) was unable to perform either a sliding or a pivot transfer. He was instrumented with an implanted functional neuromuscular stimulation (FNS) system, radio frequency-linked to a belt-worn controller. The system activated eight muscles selected from among quadriceps, hamstrings, posterior portion of the adductor magnus, gluteus maximus, and erector spinae, bilaterally. The two-stage implantation procedure included electrode implantation with percutaneous leads followed by stimulator implantation and removal of the percutaneous leads. All implants were well tolerated with no adverse effects. The subject was able independently to put on the external controller portion of the system and to perform a standing pivot transfer with only standby assistance. An unexpected outcome of the FNS system use was increased voluntary upper body strength that resulted in improvement of the sliding transfer from 'inability' to 'independent'.

Adult↗

PubMed1994

Design and clinical application of a double helix electrode for functional electrical stimulation.

An electrode, designed to be implanted without a surgical incision, was developed for skeletal muscle stimulation. Stainless steel, Teflon-insulated wire was wound into a helical lead around a polypropylene core and then rewound into a double helix configuration for stress relief during muscle contractions. The electrode tip was augmented with stainless steel barbs to increase anchoring strength. Electrodes were implanted with the help of specially modified hypodermic needles, sheaths, and passing tubes. 775 electrodes were implanted in a five year period in 22 subjects; accumulated implant time was 1,080 electrode years. 453 electrodes (65%) continue to produce strong, stable, muscle contractions. Electrode longevity varied with the location of implant. Electrodes were removed because of (1) inability to locate and properly place the electrode in a suitable site for stimulation during surgery (28.4%), (2) unwanted changes in muscle response to stimulation (91, 12%; one-third occurring during the first six weeks post implant), (3) increase in electrode impedance (74, 10%; assumed breakage, mostly occurring during the first year after implant), (4) intolerable pain during stimulation (8, 1%), and (5) infection (4, 0.5%). 67 (8%) electrodes were removed by accident or when the subjects left the program. This double helix electrode design has proven practical for achieving chronic stimulation of selected muscles in hemiplegic, paraplegic, stroke and brain-injured subjects with minimally invasive surgery.

Animals↗