Predictors of Response in Chronic Stroke

Completed · Not applicable

Conditions studied: Stroke, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases

In brief

This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significant change in impairment at the end of a robot assisted therapy intervention.The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).

Key facts

Study ID

NCT04283253

Run by

VA Pittsburgh Healthcare System

People needed

1

Starts

2019-10-22

Expected to finish

2020-03-31

Last updated by the study team

2022-03-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
• Stroke onset at least 6 months before enrollment
• Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45)
• Be medically stable to participate in the study
• Be English speaking

You may not qualify if…

• Unable to give informed consent
• Have a serious complicating medical illness that would preclude participation.
• Contractures or orthopedic problems limiting range of joint motion in the potential study arm
• Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
• Botulinum toxin to study arm within four months of study enrollment or if received during the study period
• Unable to comply with requirements of the study
• Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions
• Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions
• Have a serious complicating medical illness that would preclude participation

Where it is running

• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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