Transcranial Direct Current Stimulation (tDCS) and Task-Specific Practice for Post-stroke Neglect
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Hemispatial Neglect | Device: tDCS Device: sham tDCS Behavioral: Repetitive task-specific practice (RTP) | Phase 1 |
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 (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 |
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).
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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:
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:
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 |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Emily Grattan, PhD, OTR/L | Medical University of South Carolina |
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 |
tDCS neglect paresis transcranial direct current stimulation rehabilitation |
Stroke Perceptual Disorders Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Neurobehavioral Manifestations Neurologic Manifestations |