National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
Stroke, Hemiparesis, Spasticity as Sequela of Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring Neurolutions, IpsiHand
Eligibility Criteria
Inclusion Criteria: Adults age (18-85) Adults who sustained a CVA Have upper extremity hemiparesis/hemiplegia Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training. Exclusion Criteria: Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training. Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit. Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded. Participants receiving any formal upper extremity therapy will be excluded. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded. Participants who are pregnant or breast-feeding will be excluded. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
Sites / Locations
- Neurolutions
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
BCI treatment Group using the IpsiHand
Standard of Care - Home Exercise Program for Upper Extremity
Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2. Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.
Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home. Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.