CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Real rTMS +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00929656
NCT00929656N/ACompleted

Combining Neural and Behavioral Therapies to Enhance Stroke Recovery

VA Office of Research and Development·interventional·Posted Jun 29, 2009·Updated Aug 21, 2017

In Brief

A clinical study evaluating Real rTMS, Sham rTMS, and 1 other intervention for Stroke. Completed, enrolled 22 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2009
Enrollment StartFeb 1, 2013
Primary CompletionSep 30, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.0 years ago

Interventions

Real rTMSprocedure

rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses

Sham rTMSprocedure

sham rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses

Unimanual paretic UE Trainingprocedure

UE exercise for 4 hours (two hours 1:1 with therapist and two hours independent at home) for 16 sessions (4 sessions/week for 4 weeks)