Stroke Clinical Trial - Treatment of Chronic Stroke With IpsiHand

Status Completed

Clinical Trial Summary

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

Clinical Trial Description

This study will be carried out in two phases designed to achieve the objectives described above. The first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. This phase will involve recording EEG signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. After recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to determine the accompanying EEG signals. The EEG signals would then be used to control stimulation of the impaired limb. Rehabilitation would be assessed by examining changes in commonly used functional motor scores.

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device. ;

Study Design

Related Conditions & MeSH terms

Stroke

Clinical Trial Details

NCT number	NCT02552368
Study type	Interventional
Source	Washington University School of Medicine
Contact
Status	Completed
Phase	N/A
Start date	August 2012
Completion date	November 30, 2015

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.