Improving treatment for neglect after stroke
Improving Measurement and Treatment of Post-stroke Neglect
This study is testing a new way to help stroke survivors who have trouble paying attention to one side of their body by combining specific practice with a brain stimulation technique to see if it improves their focus and movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03317860 on ClinicalTrials.gov |
What this trial studies
This study investigates the best methods to assess and treat post-stroke neglect, a common condition where stroke survivors have difficulty attending to one side of their body or space. It explores the preliminary effects of combining repetitive task-specific practice with transcranial direct current stimulation (tDCS) to improve attention and motor function in affected individuals. Additionally, the study aims to evaluate existing neglect assessments to create a more comprehensive measurement tool for clinicians. The focus is on understanding how these interventions can enhance brain excitability and overall recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced an ischemic or hemorrhagic stroke at least three months prior and exhibit unilateral neglect.
Not a fit: Patients with severe spasticity, significant cognitive impairments, or contraindications for tDCS or MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for stroke survivors suffering from neglect, enhancing their recovery and quality of life.
How similar studies have performed: While there have been studies exploring tDCS and rehabilitation, this specific combination of interventions for post-stroke neglect is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Emily S. Grattan, PhD MS BS — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Emily S Grattan, PhD MS BS
- Email: ESG39@pitt.edu
- Phone: (412) 559-4920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.