Clinical trial NCT03317860: Improving Measurement and Treatment of Post-stroke Neglect
Official title: Improving Measurement and Treatment of Post-stroke Neglect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: perceptual disorders
cerebrovascular disorders
neurobehavioral manifestations
neurologic manifestations
neglect
non-invasive brain stimulation
rehabilitation
tDCS
paresis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-10-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in excitability of fronto-parietal connectivity
timeFrame: Participants will be assessed at baseline and 30 minutes later
Secondary outcomes:
measure: Change in upper extremity kinematics
timeFrame: Participants will be assessed at baseline and 30 minutes later
measure: Change on Behavioral Inattention Test
timeFrame: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)
Other outcomes:
measure: Catherine Bergego Scale
timeFrame: Participants in the cross-sectional study will be assessed at baseline.
measure: Behavioral Inattention Test
timeFrame: Participants in the cross-sectional study will be assessed at baseline.
measure: Naturalistic Action Test
timeFrame: Participants in the cross-sectional study will be assessed at baseline.
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Emily S. Grattan, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
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.