Biomedical subjects

Gerard E Francisco

Publications and source records attributed to Gerard E Francisco.

8 recordsLinked to original sources

PubMed2006

Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life.

OBJECTIVES: To evaluate the impact of intrathecal baclofen (ITB) on function and quality of life (QOL) and to obtain efficacy and safety data in poststroke spastic hypertonia. DESIGN: Prospective open-label multicenter trial with follow-up at 3 and 12 months. SETTING: Twenty-four stroke treatment centers in the United States. PARTICIPANTS: Ninety-four stroke participants (age range, 24-82 y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation. INTERVENTION: Participants were implanted with an ITB pump. MAIN OUTCOME MEASURES: FIM instrument and QOL (Sickness Impact Profile [SIP]) changes, spastic hypertonia (Ashworth Scale), and safety. RESULTS: FIM scores improved overall in repeated-measures analysis of variance (ANOVA) (P = .005) and by 3.00 +/- 7.69 (P = .001) at 3 months and by 2.86 +/- 10.13 (P = .017) at 12 months. Significant improvements in SIP scores were noted overall (repeated-measures ANOVA, P < .001) and at 3 (P = .003) and 12 months (P < .001). The combined average Ashworth Scale score of the upper and lower limbs decreased by 1.27 +/- 0.76 (P < .001) at 3 months and by 1.39 +/- 0.73 (P < .001) at 12 months from baseline, which was significant overall (repeated-measures ANOVA, P<.001). Strength in the unaffected side did not change overall (repeated-measures ANOVA, P = .321) or at either 3 (P = .553) or 12 months (P = .462). Minimal adverse events and device complications were reported. CONCLUSIONS: There was significant improvement in function, QOL, and spastic hypertonia at 3 and 12 months after implant, without adversely affecting muscle strength of the unaffected limbs. Data suggest that ITB therapy is a safe and efficacious treatment for spastic hypertonia resulting from stroke.

Activities of Daily Living↗

PubMed2006

Successful treatment of posttraumatic hemiballismus with intrathecal baclofen therapy.

Intrathecal baclofen (ITB) therapy is widely used in the management of spastic hypertonia and dystonia resulting from a multitude of conditions that present with upper motor neuron syndrome signs, such as cerebral palsy, stroke, brain and spinal injuries, and multiple sclerosis. We report successful management of posttraumatic hemiballismus and dystonia with ITB in a 43-yr-old man who sustained a traumatic brain injury secondary to an assault in 1978. He subsequently developed hemiballismus in the right lower limb and dystonia of the distal right upper limb spreading proximally to involve the shoulder. The ballistic movement of the lower limb was severe enough to cause the patient to fall out of his chair and limit his ability to perform activities of daily living safely. He had been on various oral medications and received botulinum toxin and phenol injections, but none alleviated the symptoms. The patient elected to receive the ITB pump. Before ITB, he had an average of 10-12 ballism episodes of the right lower limb per hour. During observed episodes, the right hip would flex up to about 90 degrees, with a fully extended knee. After ITB pump implantation and upward dose titration, the frequency of ballistic right leg movements decreased to about three per day, and the right hip flexed to only 30 degrees. In addition, there was increased ability to isolate individual distal joint movements in the right lower limb. The patient currently receives 202.4 microg/day ITB and continues to benefit almost 6 yrs after ITB pump implantation. This report highlights the emerging role of ITB in managing movement disorders other than dystonia spastic hypertonia and dystonia.

Adult↗

PubMed2006

Consensus panel guidelines for the use of intrathecal baclofen therapy in poststroke spastic hypertonia.

Intrathecal baclofen (ITB) therapy has been increasingly employed for the management of poststroke spastic hypertonia, a complication that can lead to deformity, discomfort, and exacerbation of motor impairments. Because its use in stroke is not as established as other indications, ITB therapy has not been subjected to rigorous investigation. There is limited evidence to guide clinicians regarding application of this therapy in this patient population. This article aims to review the available scientific literature and the opinion of several experts on the topic. It will also describe the recommendations of these experts with regard to addressing common clinical situations that may influence treatment decisions in the stroke population.

Baclofen↗

PubMed2004

Botulinum toxin: dosing and dilution.

In the United States, the popularity of botulinum toxins as agents to treat muscle hypertonia has grown significantly over the last decade, despite lack of approval from the Food and Drug Administration for the indication of spasticity. Botox (botulinum toxin type A) and Myobloc (botulinum toxin type B) are Food and Drug Administration-approved for other indications, such as cervical dystonia. Another commercial preparation of type A, Dysport, has yet to reach the United States market as of this writing. Although botulinum toxin's efficacy in influencing spastic hypertonia is well accepted, the impact of certain clinical issues, such as dosing and dilution, on treatment outcome is not well established by published studies. This article will review important articles and selected abstracts on the use of botulinum toxin, specifically for spastic hypertonia in adults, with emphasis on current clinical practices as they relate to dosing and dilution.

Botulinum Toxins↗

PubMed2003

Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study.

OBJECTIVE: To explore whether intrathecal baclofen (ITB) therapy improves ambulation in stroke survivors. DESIGN: Case series. SETTING: Tertiary care center. PARTICIPANTS: Ten adults with poststroke hemiparesis who were ambulatory at the time of pump implantation. INTERVENTIONS: Implantation of ITB pump after inadequate control of spasticity with other interventions. Time from stroke onset to implantation averaged 28.6 months (range, 9-55mo). MAIN OUTCOME MEASURES: Customary walking speed was measured from the time required to walk 50ft (15m) at a self-selected pace. Evaluators rated spastic hypertonia and functional mobility. RESULTS: Statistically significant improvements occurred in walking speed, functional mobility ratings, and spasticity (P<.05) at a follow-up interval that averaged 8.9 months. Mean walking speed over 50ft improved from 36.6 to 52cm/s. Mean Modified Ashworth Scale scores in the muscles of the affected lower limb improved from 2.0 to 0.4. Normal muscle strength (5/5) was preserved in the unaffected limbs. CONCLUSIONS: This preliminary study suggests that ITB therapy, in combination with physical therapy, may improve walking speed and functional mobility in ambulatory individuals with poststroke spastic hemiplegia.

Adult↗

PubMed2002

Abrupt withdrawal from intrathecal baclofen: recognition and management of a potentially life-threatening syndrome.

OBJECTIVE: To suggest guidelines for the prevention, recognition, and management of a life-threatening syndrome (high fever, altered mental status, profound muscular rigidity that sometimes progressed to fatal rhabdomyolysis) in patients who experience the abrupt withdrawal of intrathecal baclofen (ITB) therapy. DESIGN: Retrospective literature and safety-file review. SETTING: Expert panel drawn from physiatry, neurology, and neurosurgery. PARTICIPANTS: Experienced users of ITB therapy in the pediatric and adult populations in the United States. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We reviewed literature reports, MedWatch reports to the US Food and Drug Administration, and our own experiences. We critically analyzed patient management and drug therapy in the context of the pharmacology of baclofen and other antispastic agents. RESULTS: An abrupt reduction in gamma-aminobutyric acid(B) (GABA) agonist activity in the central nervous system can cause the ITB withdrawal syndrome, which is clinically and pathophysiologically distinct from autonomic dysreflexia, malignant hyperthermia, and neuroleptic-malignant syndrome. ITB withdrawal evolves over 1 to 3 days, but may become fulminant if not recognized and treated early. The syndrome can be interrupted by the restoration of ITB therapy. However, supportive measures and high-dose benzodiazepine infusion may be life saving in the interval before ITB therapy is resumed. Dantrolene infusion may relieve muscle rigidity but does not reverse the other manifestations of GABAergic agonist withdrawal. CONCLUSIONS: Most episodes of severe ITB withdrawal were preventable. Patients at risk can be identified and educated prospectively and given medication for emergency use. Treatment with GABAergic agonist drugs may prevent potentially fatal sequelae.

Anti-Anxiety Agents↗

PubMed2002

Blunt versus penetrating violent traumatic brain injury: frequency and factors associated with secondary conditions and complications.

OBJECTIVE: To compare types and frequency of medical complications and comorbidities associated with violence-related penetrating traumatic brain injury (TBI) as compared to violence-related blunt TBI. METHOD: Data were collected prospectively at four medical centers participating in the TBI Model Systems (TBIMS) of Care project. A total of 317 individuals met the inclusion criteria for the TBIMS (i.e., showed evidence of a TBI, were age 16 or older, presented to the TBIMS emergency department within 24 hours of injury, and received acute and rehabilitation services within the model system). MAIN OUTCOME MEASURES: Frequency of medical complications and comorbid diseases. RESULTS: Patients with penetrating injuries suffered significantly higher rates of respiratory failure (P =.004), pneumonitis/pneumonia, (P =.002), skull fracture (P =.001), cerebrospinal fluid leak (P =.0005), and hypotonia (P =.001) than did patients with blunt injuries. Prediction of complications and comorbidities via multiple regression revealed that a penetrating violent injury and the severity of injury were independent predictors of a higher rate of medical complications, whereas age and gender did not account for unique variance in the equation. CONCLUSIONS: Penetrating injuries are associated with higher rates of certain medical complications, especially to the pulmonary and central nervous systems. Acute care physicians and physiatrists must be prepared to treat these complications more often in patients with penetrating injuries.

Adolescent↗

PubMed2002

Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques.

OBJECTIVE: To compare the efficacy of two different volume preparations of the same dose of botulinum toxin-A in relieving spasticity in wrist and finger flexors secondary to acquired brain injury. DESIGN: Thirteen adult patients who had modified Ashworth scale scores of 3 for both wrist and finger flexors were included in this randomized, controlled trial. Wrist and finger flexors were each injected. Blinded modified Ashworth scale ratings of wrist and finger flexor spasticity were measured. RESULTS: Spasticity in both muscles decreased significantly in both treatment groups. However, the high-volume and low-volume groups did not differ significantly in spasticity reduction. CONCLUSIONS: Because this preliminary study found no difference in spasticity reduction between high- and low-volume preparations of a 60-unit dose of botulinum toxin-A, a larger-sample study seems warranted to compare the efficacy of high-volume and low-volume preparations.

Adult↗