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NCT Number: NCT03317860

Improving Measurement and Treatment of Post-stroke Neglect

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location status: Recruiting

Location contact

Amy Boos

CONTACT

[email protected]

412-648-4179

Emily S. Grattan, PhD MS BS

PRINCIPAL_INVESTIGATOR

Katie L Mullen

CONTACT

[email protected]

(412) 822-3661

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham tDCS

Device

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 tDCS

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily S Grattan, PhD MS BS

CONTACT

[email protected]

(412) 559-4920

George F Wittenberg, MD PhD

CONTACT

[email protected]

(412) 360-6185

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2017
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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