Improving Measurement and Treatment of Post-stroke Neglect

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03317860
Collaborator
(none)
17
1
2
60
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sham tDCS
  • Device: Active tDCS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants will receive both conditions (active and sham transcranial direct current stimulation paired with arm rehabilitation training [repetitive task-specific practice]) in this cross-over design study. Individuals will be randomized to determine which condition they receive first and the participant and treatment therapist and assessor will be blinded to the order that the interventions are delivered. The PI will oversee randomization so that each patient is randomized and assigned a unique five digit code. When this code is entered on the tDCS device, the device will automatically assign the patient to receive either real or sham stimulation. Because the sham stimulation provides a ramp up/ramp down stimulation for 15 seconds at the start and end of the session the participant may perceive the sham stimulation as active stimulation.
Primary Purpose:
Other
Official Title:
Improving Measurement and Treatment of Post-stroke Neglect
Actual Study Start Date :
Jul 2, 2018
Anticipated Primary Completion Date :
Jul 3, 2023
Anticipated Study Completion Date :
Jul 3, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in excitability of fronto-parietal connectivity [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 Outcome Measures

    1. Change in upper extremity kinematics [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 [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 Outcome Measures

    1. Catherine Bergego Scale [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania United States 15240

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03317860
    Other Study ID Numbers:
    • N2420-W
    • 1IK2RX002420-01A2
    First Posted:
    Oct 23, 2017
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2022