Does Reducing Spasticity Permit an Increase in Strength?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
ClinicalTrials.gov Identifier:
NCT00255073
First received: November 15, 2005
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy, resulting in numerous treatment strategies that target various parts of the motor system. However, in many children weakness may be a greater contributor to disability than spasticity. Recent results suggest a correlation between spasticity and weakness, but it is not known if reduction of spasticity can improve strength.

We suggest a simplified model in which spinal mechanisms (including reflex contributions to spasticity) and supraspinal mechanisms (including voluntary contributions to strength) combine to activate muscle. The model implies that the supraspinal contribution cannot increase unless the spinal contribution decreases. We therefore hypothesize that reduction of spasticity improves the ability to increase voluntary strength.

We propose a double-masked placebo-controlled clinical trial combining treatment using the oral anti-spasticity medication baclofen with a 6-week program of strength training. We will enroll 20 ambulatory children with spastic diplegic cerebral palsy. Prior to and following the intervention, we will obtain quantitative measures of spasticity, strength, and gait. We predict that the children taking baclofen will have a greater increase in strength than the children taking placebo. We predict that the increase in strength will be reflected in improved performance on gait analysis, and it will correlate with a reduction in quantitative measures of spasticity and spinal reflex excitability.

If the hypothesis is correct, it will provide important new information on the relationship between spasticity and strength in children with cerebral palsy. It will provide the first measurements of the effect of baclofen on voluntary muscle activation in children. It will support the short-term use of combined anti-spasticity medication and strengthening as a new clinical treatment for ankle weakness in children with spastic diplegia. A successful result will have immediate and significant implications for treatment of children with cerebral palsy.


Condition Intervention Phase
Spastic Diplegic Cerebral Palsy
Drug: baclofen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Reducing Spasticity Permit an Increase in Strength?

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Maximal Voluntary Contraction

Secondary Outcome Measures:
  • H reflex

Estimated Enrollment: 10
Study Start Date: January 2005
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Diagnosis of Cerebral Palsy 2. Spasticity at extensor muscle groups of one or both ankles according to the definition of the Task Force on Childhood Motor Disorders, and as evidenced by the presence of a spastic catch or velocity-dependent hypertonia on rapid passive muscle lengthening while the subject attempts to maintain a relaxed state 3. Ambulatory without assistive devices 4. Sufficient ability to follow instructions to be able to comply with the strengthening program and strength testing

Exclusion Criteria:

  • 1. Contracture at the ankle, or a limitation of the passive range of motion such that neutral position is not achievable with the knee extended.

    2. Hypersensitivity or allergy to Baclofen or related medications, or any medical condition that would be expected to increase the risks of this study 3. Respiratory difficulty due to weakness, restrictive lung disease, obstructive lung disease, tracheomalacia, or laryngeal weakness 4. Renal failure or chronic kidney disease 5. Pregnancy or planned pregnancy (sexually active girls will be asked to take a urine pregnancy test prior to study entry) 6. Difficulty maintaining head position while standing or seated 7. Current use of other anti-spasticity agents, including valium, tizanidine, clonidine, dantrolene, or similar agents 8. Use of oral baclofen within 3 months prior to study entry 9. Injection of botulinum toxin into the calf muscles within 3 months prior to study entry 10. Prior implantation of a baclofen pump or deep-brain stimulator 11. Seizure within previous two years 12. Lower extremity dystonia 13. Bradykinesia or evidence of parkinsonism 14. Spinal cord injury 15. Neurodegenerative disease 16. Ankle, foot, lower leg, or Achilles tendon surgery within the previous year 17. Dorsal rhizotomy or neurotomy

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00255073

Locations
United States, California
Stanford University
Stanford, California, United States, 94305-5235
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Terence Sanger, md,phd Stanford University
  More Information

No publications provided

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00255073     History of Changes
Other Study ID Numbers: BACLOFEN
Study First Received: November 15, 2005
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014