Improving Measurement and Treatment of Post-stroke Neglect
2 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jul 2018
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
September 17, 2025
September 1, 2025
8.3 years
October 18, 2017
September 16, 2025
Conditions
Keywords
Outcome Measures
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.
Participants will be assessed at baseline and 30 minutes later
Secondary Outcomes (2)
Change in upper extremity kinematics
Participants will be assessed at baseline and 30 minutes later
Change on Behavioral Inattention Test
Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)
Other Outcomes (3)
Catherine Bergego Scale
Participants in the cross-sectional study will be assessed at baseline.
Behavioral Inattention Test
Participants in the cross-sectional study will be assessed at baseline.
Naturalistic Action Test
Participants in the cross-sectional study will be assessed at baseline.
Study Arms (2)
Sham tDCS plus RTP
SHAM COMPARATORSingle session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Active tDCS plus RTP
ACTIVE COMPARATORSingle session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Related Publications (1)
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.
PMID: 34196963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily S. Grattan, PhD MS BS
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2017
First Posted
October 23, 2017
Study Start
July 2, 2018
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share