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Transcranial Direct Current Stimulation (tDCS) and Task-Specific Practice for Post-stroke Neglect

Primary Purpose

Stroke, Hemispatial Neglect

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tDCS
sham tDCS
Repetitive task-specific practice (RTP)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, neglect, paresis, transcranial direct current stimulation, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Parietal tDCS plus RTP

Primary motor cortex tDCS plus RTP

Sham tDCS plus RTP

Arm Description

Single session of bilateral parietal tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP).

Single session of bilateral primary motor cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)

Single session of sham tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in kinematics
A kinematic assessment will be conducted to assess changes in motor impairment.
Change on Behavioral Inattention Test
A neglect assessment will be conducted to assess changes in attentional impairment.

Full Information

First Posted
August 10, 2016
Last Updated
September 3, 2021
Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02892097
Brief Title
Transcranial Direct Current Stimulation (tDCS) and Task-Specific Practice for Post-stroke Neglect
Official Title
Examining the Effects of Transcranial Direct Current Stimulation and Task-specific Practice on Cortical Modulation Among Individuals With Unilateral Spatial Neglect Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrolled 1 participant, PI left the institution.
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Unilateral neglect (neglect) is common after stroke and is characterized by an inattention to one side of the body or environment. There is growing evidence that disconnections to fronto-parietal neural networks in the lesioned hemisphere not only cause neglect, but also cause these same networks to be hyperexcited in the non-lesioned hemisphere. Individuals with neglect typically experience motor impairments also since the regions of the brain that control attention also control movement. Transcranial direct current stimulation (tDCS) when paired with repetitive task-specific practice (RTP) has the potential to modulate cortical activity (fronto-parietal networks) and facilitate motor and attentional recovery for individuals with neglect since tDCS can modulate the excitability of targeted cortical regions. tDCS is a form on non-invasive brain stimulation and RTP is the gold standard post-stroke motor recovery intervention. It is particularly important investigators examine the effect of RTP + tDCS on cortical modulation in order to understand the underlying mechanism of the intervention and determine whether RTP+ tDCS (parietal or primary motor cortex [M1]) promotes greater neural modulation than RTP alone. Traditionally, electrodes are placed on M1 to facilitate motor recovery and on the parietal lobe to facilitate attentional recovery, however this intervention is designed to target each of these impairments (motor, attention) and enhance cortical modulation of fronto-parietal networks. Therefore, investigators must also determine the optimal electrode montage and placement for pairing tDCS with RTP for individuals with neglect. The purpose of the proposed pilot project is to examine the effects of transcranial direct current stimulation (tDCS) paired with repetitive task-specific practice (RTP) on modulation of fronto-parietal network connectivity (measured by transcranial magnetic stimulation [TMS]), motor impairment (measured with kinematic assessment), and attentional impairment (measured with Behavioral Inattention Test) among individuals with unilateral neglect and hemiparesis post stroke. This three day cross-over design study will examine the optimal electrode placement and montage using 3 conditions: (1) tDCS to parietal lobe + RTP (2) tDCS to primary motor cortex + RTP (3) sham tDCS + RTP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemispatial Neglect
Keywords
tDCS, neglect, paresis, transcranial direct current stimulation, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parietal tDCS plus RTP
Arm Type
Active Comparator
Arm Description
Single session of bilateral parietal tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP).
Arm Title
Primary motor cortex tDCS plus RTP
Arm Type
Active Comparator
Arm Description
Single session of bilateral primary motor cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Arm Title
Sham tDCS plus RTP
Arm Type
Sham Comparator
Arm Description
Single session of sham tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
noninvasive brain stimulation, transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
Intervention Type
Behavioral
Intervention Name(s)
Repetitive task-specific practice (RTP)
Other Intervention Name(s)
task practice
Intervention Description
Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
Primary Outcome Measure Information:
Title
Change in excitability of fronto-parietal connectivity
Description
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.
Time Frame
Participants will be assessed at baseline and 30 minutes later (immediately following intervention session).
Secondary Outcome Measure Information:
Title
Change in kinematics
Description
A kinematic assessment will be conducted to assess changes in motor impairment.
Time Frame
Participants will be assessed at baseline and 1 hour later (immediately following intervention session).
Title
Change on Behavioral Inattention Test
Description
A neglect assessment will be conducted to assess changes in attentional impairment.
Time Frame
Participants will be assessed at baseline and 1.5 hours later (immediately following intervention session).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Grattan, PhD, OTR/L
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Direct Current Stimulation (tDCS) and Task-Specific Practice for Post-stroke Neglect

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