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Transcranial Direct Current Stimulation

tDCS for Post-Stroke Neglect

N/A
Recruiting
Led By Emily S. Grattan, PhD OTR MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Presence of any MRI, TMS, tDCS risk factors including: history of seizures, history of brain tumor, hardware in skull or spine (e.g. coils, clips), implantable medical device (e.g. pacemaker), metal in body (not compatible with MRI), pregnancy
History of cortical hemorrhagic stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants in the cross-sectional study will be assessed at baseline.

Summary

This trial will test a new intervention for post-stroke neglect, which combines repetitive task-specific practice with transcranial direct current stimulation. The goal is to establish a more comprehensive neglect measure.

Who is the study for?
This trial is for individuals who had a stroke at least 3 months ago and are experiencing unilateral neglect, with specific scores on the Virtual Reality Lateralized Attention Test and Fugl-Meyer Upper Extremity assessment. They must have inducible motor responses in their thumb muscles but cannot have severe spasticity, significant language or cognitive impairments, or any conditions that pose risks to MRI, TMS, or tDCS procedures.
What is being tested?
The study is testing an innovative treatment combining repetitive task-specific practice with transcranial direct current stimulation (tDCS) to improve attention deficits after a stroke. Participants will be randomly assigned to receive either active tDCS or a sham (placebo) version alongside their exercises.
What are the potential side effects?
Transcranial direct current stimulation may cause mild side effects such as itching, tingling, or discomfort at the electrode site. More serious risks include seizures; however these are rare. The sham procedure should not cause any side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a history of seizures, brain tumors, metal implants, or am not pregnant.
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I have had a bleeding stroke in the brain's outer layer.
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I experience severe muscle stiffness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be assessed at baseline and 30 minutes later
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed at baseline and 30 minutes later for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in excitability of fronto-parietal connectivity
Secondary study objectives
Change in upper extremity kinematics
Change on Behavioral Inattention Test
Other study objectives
Behavioral Inattention Test
Catherine Bergego Scale
Naturalistic Action Test

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active tDCS plus RTPActive Control1 Intervention
Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Group II: Sham tDCS plus RTPPlacebo Group1 Intervention
Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,652 Total Patients Enrolled
86 Trials studying Stroke
6,866 Patients Enrolled for Stroke
Emily S. Grattan, PhD OTR MSPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
Emily S. Grattan, PhD MS BSPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Media Library

Active tDCS (Transcranial Direct Current Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03317860 — N/A
Stroke Research Study Groups: Sham tDCS plus RTP, Active tDCS plus RTP
Stroke Clinical Trial 2023: Active tDCS Highlights & Side Effects. Trial Name: NCT03317860 — N/A
Active tDCS (Transcranial Direct Current Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03317860 — N/A
~2 spots leftby Sep 2025
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