Combined Neural and Behavioral Therapies to Enhance Stroke Recovery

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

Stroke is the leading cause of long-term disability in this country with more than 1 million Americans reporting difficulty with daily activities. Loss of independence in self-care tasks is primarily due to limited recovery of the arm. This study will determine if the addition of Transcranial Magnetic Stimulation (TMS) to excite the lesioned hemisphere (side of the brain affected by the stroke), to progressive functional task exercise either of the weakened arm alone or of both arms together will improve arm recovery to a greater degree than one of these two types of arm exercise alone. Individuals post-stroke will participate in 16 sessions of 1) arm rehabilitation alone (with the weaker arm only or with both arms together) or 2) arm rehabilitation plus TMS. The investigators will assess arm movement ability and function immediately following the 4-week intervention and at a 30-day follow-up to determine retention of immediate gains. The investigators hypothesize that those who receive TMS as an adjuvant will have improved arm movement ability than those who only exercise.

Key facts

Study ID

NCT00929656

Run by

VA Office of Research and Development

People needed

22

Starts

2013-02-01

Expected to finish

2015-09-30

Last updated by the study team

2017-08-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1st stroke > 6 months
• Sub-cortical stroke confirmed with CT or MRI
• Passive range of motion in bilateral shoulder and elbow within functional limits
• UE Fugl-Meyer shoulder/elbow subcomponent score between 15 - 25
• 18-80 years of age

You may not qualify if…

• Use of medications that may lower seizure threshold
• History of epilepsy, brain tumor, learning disorder, mental retardation, drug or alcohol abuse, dementia, major head trauma, or major psychiatric illness
• evidence of epileptiform activity on EEG obtained before beginning treatment
• history or radiographic evidence of arteriovenous malformation, intracortical hemorrhage, subarachnoid hemorrhage, or bilateral cerebrovascular disease,
• history of cortical stroke
• history of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull
• pregnancy
• pain in either upper extremity that would interfere with movement
• unable to understand 3-step directions
• orthopedic condition in back or UE or impaired corrected vision that would alter kinematics of reaching

Where it is running

• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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