What this study is
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.
What's being tested
- Sham transcranial direct current stimulation (tDCS)
Intervention · DEVICE
- Active direct current stimulation (tDCS)
Intervention · DEVICE
Both interventions
Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train
Study details
- Sponsor
- VA Office of Research and Development
- Conditions
- Stroke
- Enrolling
- 17 people
- Starts
- 2018-07-02
- Est. completion
- 2027-09-30
- Design
- Triple-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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, Memorandum of Understanding (MOU) approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
- Amy Boos · Contact(412) 648-4179amy.boos2@va.gov
- Katie L Mullen · Contact(412) 822-3661Katie.Mullen@va.gov
- Emily S. Grattan, PhD MS BS · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID N2420-W
Principal investigator
Emily S. Grattan, PhD MS BS
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.