We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892097
Recruitment Status : Terminated (Enrolled 1 participant, PI left the institution.)
First Posted : September 8, 2016
Last Update Posted : September 13, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stroke Hemispatial Neglect Device: tDCS Device: sham tDCS Behavioral: Repetitive task-specific practice (RTP) Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • noninvasive brain stimulation
  • transcranial direct current 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 Name: 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:
  • noninvasive brain stimulation
  • transcranial direct current 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 Name: task practice
Sham Comparator: Sham tDCS plus RTP
Single session of sham tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
 Device: sham tDCS
Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.

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 Name: task practice


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892097


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Emily Grattan, PhD, OTR/L Medical University of South Carolina
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02892097    
Other Study ID Numbers: PRO00056688
P2CHD086844 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medical University of South Carolina:
tDCS
neglect
paresis
transcranial direct current stimulation
rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations