Improving Measurement and Treatment of Post-stroke Neglect

September 16, 2025 updated by: VA Office of Research and Development
This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Emily S Grattan, PhD MS BS
  • Phone Number: (412) 559-4920
  • Email: ESG39@pitt.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Recruiting
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Principal Investigator:
          • Emily S. Grattan, PhD MS BS
        • Contact:
        • Contact:

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

Description

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke 3 months post stroke.
  • Fugl-Meyer Upper Extremity (FMA-Upper Extremity) score between 20-56/60
  • Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the paretic stimulation (TMS)
  • Demonstrate the presence of unilateral neglect (Virtual Reality Lateralized Attention Test score <18)

Exclusion Criteria:

  • History of cortical hemorrhagic stroke

  • 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
  • Severe spasticity (Modified Ashworth Scale score 3)
  • Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
  • Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, MOU approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham tDCS plus RTP
Single session of bilateral sham parietal cortex 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. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.

Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train

Other Names:
  • noninvasive brain stimulation, transcranial direct current stimulation
Active Comparator: Active tDCS plus RTP
Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Device: Active tDCS

Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.

Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train

Other Names:
  • noninvasive brain stimulation, transcranial direct current stimulation

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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in upper extremity kinematics
Time Frame: Participants will be assessed at baseline and 30 minutes later
A kinematic assessment will be conducted to assess changes in motor impairment.
Participants will be assessed at baseline and 30 minutes later
Change on Behavioral Inattention Test
Time Frame: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)
A neglect assessment (conventional subtests) will be conducted to assess changes in attentional impairment. Total scores range from 0-146 with lower scores indicating greater impairment.
Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catherine Bergego Scale
Time Frame: Participants in the cross-sectional study will be assessed at baseline.
This neglect assessment will be administered to examine the impact of neglect on performance of daily activities. Total scores range from 0-30 with higher scores indicating greater impairment.
Participants in the cross-sectional study will be assessed at baseline.
Behavioral Inattention Test
Time Frame: Participants in the cross-sectional study will be assessed at baseline.
This neglect assessment (behavioral subtests) will be administered to examine the impact of neglect on performance of daily activities. Total scores range from 0-81 with lower scores indicating greater impairment.
Participants in the cross-sectional study will be assessed at baseline.
Naturalistic Action Test
Time Frame: Participants in the cross-sectional study will be assessed at baseline.
This neglect assessment will be administered to examine the impact of neglect on performance of daily activities. Each item has a score of 0-6 with lower scores indicating greater impairment. The Lateralized Attention Score (LAS) is difference between the contralateral and ipsilateral proportion of items. Higher LAS scores indicate greater impairment.
Participants in the cross-sectional study will be assessed at baseline.

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Emily S. Grattan, PhD MS BS, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 2, 2018

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2420-W
  • 1IK2RX002420-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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