Combined Neural and Behavioral Therapies to Enhance Stroke Recovery

NCT00929656 | Completed Results

• 1 other identifier: B6862-W
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Rehabilitation; Neurophysiology; Upper Extremity

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test Change

  Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention). The time to complete 15 separate upper extremity functional tasks are recorded. These 15 separate timed events are averaged to provide one time, in seconds. This is considered an Activity Measure on the WHO ICF model.

  Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)

Secondary Outcomes (4)

• Upper Extremity Fugl-Meyer Motor Assessment Change

  Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)

• Grip Strength Change

  Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)

• Motor Activity Log - Amount of Use Change

  Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)

• Motor Activity Log - How Well Change

  Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)

Study Arms (2)

Real rTMS

EXPERIMENTAL

Real rTMS + unimanual paretic UE training

Procedure: Real rTMS; Procedure: Unimanual paretic UE Training

Sham rTMS

ACTIVE COMPARATOR

Sham rTMS + unimanual paretic UE training

Procedure: Sham rTMS; Procedure: Unimanual paretic UE Training

Interventions

Real rTMS PROCEDURE

rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses

Real rTMS

Sham rTMS PROCEDURE

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

Sham rTMS

Unimanual paretic UE Training PROCEDURE

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)

Real rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Dorian Rose, Research Health Scientist
• Organization: Malcom Randall VAMC

Dorian.Rose@va.gov

352-376-1611

Study Officials

• Dorian Kay Rose, PhD MS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: February 1, 2013
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: August 21, 2017
• Results First Posted: July 5, 2017

Record last verified: 2017-07

Locations

US (1)