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Improving Measurement and Treatment of Post-stroke Neglect

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham tDCS
Active tDCS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring perceptual disorders, cerebrovascular disorders, neurobehavioral manifestations, neurologic manifestations, neglect, non-invasive brain stimulation, rehabilitation, tDCS, paresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham tDCS plus RTP

Active tDCS plus RTP

Arm Description

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

Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in upper extremity kinematics
A kinematic assessment will be conducted to assess changes in motor impairment.
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.

Full Information

First Posted
October 18, 2017
Last Updated
November 30, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03317860
Brief Title
Improving Measurement and Treatment of Post-stroke Neglect
Official Title
Improving Measurement and Treatment of Post-stroke Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
perceptual disorders, cerebrovascular disorders, neurobehavioral manifestations, neurologic manifestations, neglect, non-invasive brain stimulation, rehabilitation, tDCS, paresis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS plus RTP
Arm Type
Sham Comparator
Arm Description
Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Arm Title
Active tDCS plus RTP
Arm Type
Active Comparator
Arm Description
Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Other Intervention Name(s)
noninvasive brain stimulation, transcranial direct current stimulation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
noninvasive brain stimulation, transcranial direct current stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in excitability of fronto-parietal connectivity
Description
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 Outcome Measure Information:
Title
Change in upper extremity kinematics
Description
A kinematic assessment will be conducted to assess changes in motor impairment.
Time Frame
Participants will be assessed at baseline and 30 minutes later
Title
Change on Behavioral Inattention Test
Description
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 Pre-specified Outcome Measures:
Title
Catherine Bergego Scale
Description
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.
Title
Behavioral Inattention Test
Description
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.
Title
Naturalistic Action Test
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily S Grattan, PhD MS BS
Phone
(412) 559-4920
Email
ESG39@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily S. Grattan, PhD MS BS
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily S Grattan, PhD MS BS
Phone
412-559-4920
Email
ESG39@pitt.edu
First Name & Middle Initial & Last Name & Degree
Emily S. Grattan, PhD MS BS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34196963
Citation
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.
Results Reference
derived

Learn more about this trial

Improving Measurement and Treatment of Post-stroke Neglect

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