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

NCT00462449 | Completed Results DMC

• 1 other identifier: 0611012
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Extremity Spasticity; Stroke; Acquired Brain Injury

Keywords

Botulinum Toxin; Ness H200; Functional Electrical Stimulation; Repetitive Task Practice

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)

  upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.

  12 weeks

Secondary Outcomes (2)

• Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)

  12 weeks

• Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)

  12 weeks

Study Arms (2)

1

NO INTERVENTION

Individuals randomized into this group will only receive specialized therapy associated with this population.

2

EXPERIMENTAL

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

Interventions

Functional Electrical Stimulation (FES) through the Ness H200 DEVICE

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.

Also known as: NESS H200™ Product Specification

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Allergan: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (27)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Michael C. Munin
• Organization: Department of Physical Medicine and Rehabilitation University of Pittsburgh

muninm@upmc.edu

412-648-6848

Study Officials

• Michael C. Munin, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 19, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 20, 2014
• Results First Posted: June 20, 2014

Record last verified: 2014-06

Locations

US (1)