Improving Measurement and Treatment of Post-stroke Neglect

VA Office of Research and Development

Status: Enrolling

Conditions: Stroke

Treatments: Device: Sham tDCS; Device: Active tDCS

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03317860

1IK2RX002420-01A2 (U.S. NIH Grant/Contract)

N2420-W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 2 patient groups

Sham tDCS plus RTP

Sham Comparator group

Description:

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

Treatment:

Device: Sham tDCS

Active tDCS plus RTP

Active Comparator group

Description:

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

Treatment:

Device: Active tDCS