Enhancing Plasticity in Stroke Patients With Severe Motor Deficit

This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in poorly recovered stroke patients. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy.

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Key information

Conditions

Stroke Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Organizing Pneumonia Respiratory Tract Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Stroke is one of the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training especially in poorly recovered stroke patients. This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in stroke patients with severe motor deficit. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic stroke patients
Single stroke
Chronic (more than 12 months after from stroke)
At least 21 years old, but there is no upper age range for this project.
Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

Exclusion criteria

History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
Cognitive deficit severe enough to preclude informed consent
Positive pregnancy test or being of childbearing age and not using appropriate contraception
Participants with history of untreated depression.

Treatment and study plan

S88 Dual Output Stimulator by Grass Technologies

Device

Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy

Primary outcomes

Change in Fugl Meyer Assessment Motor Score

Time frame: baseline, post-intervention, 1-month follow-up

Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.

Secondary outcomes

Change in Action Arm Research Test (ARAT)

Time frame: baseline, post-intervention, 1-month follow-up

Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.
Change in Wolf Motor Function Test (WMFT)

Time frame: baseline, post-intervention, 1-month follow-up

Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.

Sponsors and collaborators

Lead sponsor

Lumy Sawaki

Other

Registry information

Official study title

Enhancing Cortical Plasticity With Nerve Stimulation in Stroke Patients With Severe Motor Deficit

Important dates

Study start: 2005
Primary completion: 2013
Study completion: 2013
First posted: Dec 17, 2015
Registry last updated: Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed