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RecruitingNCT03317860Updated Sep 4, 2026

Improving Measurement and Treatment of Post-stroke Neglect

An interventional study of Sham transcranial direct current stimulation (tDCS) and Active direct current stimulation (tDCS) in Stroke, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stroke

Keywords

  • perceptual disorders
  • cerebrovascular disorders
  • neurobehavioral manifestations
  • neurologic manifestations
  • neglect
  • non-invasive brain stimulation
  • rehabilitation
  • tDCS
  • paresis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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, Memorandum of Understanding (MOU) approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
17 participants (estimated)

Study arms

  • Sham comparator
    Sham transcranial direct current stimulation (tDCS) plus repetitive task-specific practice (RTP)

    Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)

    Device: Sham transcranial direct current stimulation (tDCS)

  • 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 direct current stimulation (tDCS)

Interventions

  • DeviceSham transcranial direct current stimulation (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

    Also known as: noninvasive brain stimulation, transcranial direct current stimulation

  • DeviceActive direct current stimulation (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

    Also known as: noninvasive brain stimulation, transcranial direct current stimulation

05

What researchers measure

Primary outcomes

  1. Change in excitability of fronto-parietal connectivity

    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.

    Time frame: Participants will be assessed at baseline and 30 minutes later

Secondary outcomes

  1. Change in upper extremity kinematics

    A kinematic assessment will be conducted to assess changes in motor impairment.

    Time frame: Participants will be assessed at baseline and 30 minutes later

  2. Change on Behavioral Inattention Test

    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.

    Time frame: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)

Other outcomes

  1. Catherine Bergego Scale

    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.

    Time frame: Participants in the cross-sectional study will be assessed at baseline.

  2. Behavioral Inattention Test

    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.

    Time frame: Participants in the cross-sectional study will be assessed at baseline.

  3. Naturalistic Action Test

    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.

    Time frame: Participants in the cross-sectional study will be assessed at baseline.

06

Study locations

1 of 1 sites recruiting
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
    • Amy Boos · Contact · amy.boos2@va.gov · (412) 648-4179
    • Katie L Mullen · Contact · Katie.Mullen@va.gov · (412) 822-3661
    • Emily S. Grattan, PhD MS BS · Principal investigator
    Recruiting
07

References and documents

Publications

  • Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4. PubMed 34196963 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03317860
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Jul 2, 2018
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Emily S Grattan, PhD MS BS
Contact
ESG39@pitt.edu
(412) 559-4920
Emily S. Grattan, PhD MS BS
principal investigator · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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