Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity (Botox + FES)

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Michael C. Munin, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00462449
First received: April 17, 2007
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord.

Repetitive task practice is an "activity-based" therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice.

Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.


Condition Intervention
Upper Extremity Spasticity
Stroke
Acquired Brain Injury
Device: Functional Electrical Stimulation (FES) through the Ness H200

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Blind, Randomized Study to Determine the Safety and the Efficacy of Using Functional Electrical Stimulation (FES) and Repetitive Task Practice vs. Repetitive Task Practice Alone in Persons Receiving Botulinum Neurotoxin Type A Injections for Upper Extremity Spasticity

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.


Secondary Outcome Measures:
  • Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)

  • Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.


Enrollment: 23
Study Start Date: November 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Individuals randomized into this group will only receive specialized therapy associated with this population.
Experimental: 2
In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
Device: Functional Electrical Stimulation (FES) through the Ness H200
Specialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device.
Other Name: NESS H200™ Product Specification

Detailed Description:

This is a single-blinded, randomized controlled trial examining the effect of repetitive task practice (RTP) and functional electrical stimulation (FES) in individuals who receive routine clinical Botox ® injections for upper extremity spasticity. Botox® injections in combination with repetitive task practice (RTP) is used routinely to manage upper limb spasticity after stroke or acquired brain injury. RTP is an activity-based rehabilitation program that has been shown effective in promoting motor recovery (Wolf et al., 2002), but it requires a sufficient level of baseline motor function. Since FES enhances motor function, we hypothesize that an FES-assisted RTP intervention will provide greater improvement in hand function than RTP alone in patients receiving Botox ® injections.

The primary outcome will be upper extremity use during activities of daily living assessed observationally by the motor activities log (MAL-O). Secondary outcomes will be 1) dexterous hand function as measured by the action research arm test (ARAT); 2) client's perception of self-performance in activities of daily living assessed with the (MAL - Self Report); 3) global upper extremity impairment assessed by the Chedoke-McMaster Assessment (CMA); and 4) clinical spasticity assessed by the Modified Ashworth Scale (MAS).

The primary endpoint will be 6 weeks post-injection. Outcomes will also be assessed at a secondary endpoint, 12 weeks post-injection, to determine the persistence of treatment effects.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors.
  • Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors.
  • Subjects must meet criteria for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included.
  • Botulinum toxin A (Botox®) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment).
  • Able to answer reliably to yes/no questions.
  • Able to follow reliably 1-step instructions.
  • Written informed consent.
  • Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded.

Exclusion Criteria:

  • Uncontrolled, clinically significant medical condition other than the condition under evaluation.
  • Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI.
  • Known allergy or sensitivity to any of the components in the study medication.
  • Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
  • Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
  • Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study.
  • Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
  • Evidence of recent alcohol or drug abuse.
  • Infection or skin disorder at an anticipated injection and/or electrical stimulation sites.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Use of aminoglycoside antibiotics, curare like agents, or other agents that might interfere with neuromuscular function.
  • Individuals with a cardiac pacemaker, a defibrillator, or baclofen pump.
  • Individuals with an unhealed or healing fracture or dislocation in the arm to be evaluated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462449

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Allergan
Investigators
Principal Investigator: Michael C. Munin, M.D. University of Pittsburgh
  More Information

Publications:
Liberson WT (1962) Functional electrotherapy. Trans Am Soc Artif Intern Organs 8: 373-377
Rose DK, Winstein CJ, Tan SM, Azen SP, Chui HC. (2001). Comparison of upper extremity intervention strategies at six and nine months post-stroke. Neurol Rep 25: 130.
Winstein CJ, Rose DK, Chui HC et al. (2001) Recovery and rehabilitation of arm use after stroke. J Stroke Cerebrovasc Dis 10: 197.

Responsible Party: Michael C. Munin, M.D., Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00462449     History of Changes
Other Study ID Numbers: 0611012
Study First Received: April 17, 2007
Results First Received: August 11, 2011
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Botulinum Toxin
Ness H200
Functional Electrical Stimulation
Repetitive Task Practice

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Brain Injuries
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014