Treatment of Chronic Stroke With IpsiHand
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): IpsiHand Device
Intervention type(s): Device
Intervention description(s): Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke Rehabilitation; BCI; Stroke; Upper Extremity Rehabilitation; paresis; hemiparesis