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Clinical Trials/NCT03317860
NCT03317860
Recruiting
Not Applicable

Improving Measurement and Treatment of Post-stroke Neglect

VA Office of Research and Development1 site in 1 country17 target enrollmentJuly 2, 2018
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
VA Office of Research and Development
Enrollment
17
Locations
1
Primary Endpoint
Change in excitability of fronto-parietal connectivity
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2018
End Date
September 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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

  • 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))

Study Sites (1)

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