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

September 3, 2021 updated by: Medical University of South Carolina

Examining the Effects of Transcranial Direct Current Stimulation and Task-specific Practice on Cortical Modulation Among Individuals With Unilateral Spatial Neglect Post Stroke

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parietal tDCS plus RTP
Single session of bilateral parietal tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP).
Device: tDCS
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.
Other Names:
  • transcranial direct current stimulation
  • noninvasive brain stimulation
Behavioral: Repetitive task-specific practice (RTP)
Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
Other Names:
  • task practice
Active Comparator: Primary motor cortex tDCS plus RTP
Single session of bilateral primary motor cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Device: tDCS
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.
Other Names:
  • transcranial direct current stimulation
  • noninvasive brain stimulation
Behavioral: Repetitive task-specific practice (RTP)
Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
Other Names:
  • task practice
Sham Comparator: Sham tDCS plus RTP
Single session of sham tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Behavioral: Repetitive task-specific practice (RTP)
Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
Other Names:
  • task practice
Device: sham tDCS
Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in excitability of fronto-parietal connectivity
Time Frame: Participants will be assessed at baseline and 30 minutes later (immediately following intervention session).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in kinematics
Time Frame: Participants will be assessed at baseline and 1 hour later (immediately following intervention session).
A kinematic assessment will be conducted to assess changes in motor impairment.
Participants will be assessed at baseline and 1 hour later (immediately following intervention session).
Change on Behavioral Inattention Test
Time Frame: Participants will be assessed at baseline and 1.5 hours later (immediately following intervention session).
A neglect assessment will be conducted to assess changes in attentional impairment.
Participants will be assessed at baseline and 1.5 hours later (immediately following intervention session).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Emily Grattan, PhD, OTR/L, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 7, 2017

Study Completion (Actual)

November 7, 2017

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00056688
  • P2CHD086844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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