Study Stopped
Enrolled 1 participant, PI left the institution.
Transcranial Direct Current Stimulation (tDCS) and Task-Specific Practice for Post-stroke Neglect
Examining the Effects of Transcranial Direct Current Stimulation and Task-specific Practice on Cortical Modulation Among Individuals With Unilateral Spatial Neglect Post Stroke
2 other identifiers
interventional
1
1 country
1
Brief Summary
The purpose of this study is to test the effects of three different rehabilitation training sessions that combine non-invasive brain stimulation (transcranial direct current stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with unilateral spatial neglect following stroke. This study is designed to determine the effects of tDCS + RTP on the excitability in the brain, attention to the affected side, and arm movement ability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 stroke
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2017
CompletedSeptember 13, 2021
September 1, 2021
1.4 years
August 10, 2016
September 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in excitability of fronto-parietal connectivity
Excitability of fronto-parietal connectivity measured by paired pulse twin coil transcranial magnetic stimulation (TMS) test. In each session, the difference in excitability of fronto-parietal connectivity between pre and post stimulation will be measured.
Participants will be assessed at baseline and 30 minutes later (immediately following intervention session).
Secondary Outcomes (2)
Change in kinematics
Participants will be assessed at baseline and 1 hour later (immediately following intervention session).
Change on Behavioral Inattention Test
Participants will be assessed at baseline and 1.5 hours later (immediately following intervention session).
Study Arms (3)
Parietal tDCS plus RTP
ACTIVE COMPARATORSingle session of bilateral parietal tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP).
Primary motor cortex tDCS plus RTP
ACTIVE COMPARATORSingle session of bilateral primary motor cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Sham tDCS plus RTP
SHAM COMPARATORSingle session of sham tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Interventions
tDCS is a form of noninvasive brain stimulation. Electrodes are placed on the scalp (parietal or primary motor cortex) and deliver a low level of direct current (2mA). tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
Eligibility Criteria
You may qualify if:
- Unilateral hemispheric ischemic stroke or hemorrhagic subcortical stroke ≥3 months post stroke (lesion type and location to be confirmed with MRI)
- Neglect (Virtual Reality Lateralized Attention Test score \<18)
- Upper extremity Fugl-Meyer score between 20-56/60
- Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the affected side using transcranial magnetic stimulation (TMS)
- ≥18 years old
You may not qualify if:
- History of cortical hemorrhagic stroke
- Severe spasticity (Modified Ashworth Scale score ≥3) in paretic upper extremity
- Severe aphasia limiting participant's ability to follow 2 step directions
- History of seizures
- History of brain tumor
- History of skull defect
- Hardware in skull or spine (e.g. coils, clips)
- Implantable medical device (e.g. pacemaker)
- Metal in body that is not compatible with MRI
- Pregnant (women of child bearing age will be asked if they are pregnant or could possibly be pregnant)
- Unable to travel to Upper Extremity Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions
- Currently enrolled in another study using transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Grattan, PhD, OTR/L
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
September 8, 2016
Study Start
July 1, 2016
Primary Completion
November 7, 2017
Study Completion
November 7, 2017
Last Updated
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share