Improving Measurement and Treatment of Post-stroke Neglect

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Sham tDCS; Device: Active tDCS

• Registration Number: NCT03317860
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Study Start: 2018-07-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham tDCS plus RTP	Sham tDCS	Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Active tDCS plus RTP	Active tDCS	Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States