National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

• ClinicalTrials.gov Identifier: NCT05965713
• Recruitment Status: Not yet recruiting
• First Posted: July 28, 2023
• Last Update Posted: July 28, 2023
• Sponsor: Neurolutions, Inc.
• Collaborator: Washington University School of Medicine
• Information provided by (Responsible Party): Neurolutions, Inc.

Tracking Information

• First Submitted Date: July 18, 2023
• First Posted Date: July 28, 2023
• Last Update Posted Date: July 28, 2023
• Estimated Study Start Date: October 1, 2023
• Estimated Primary Completion Date: January 10, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2023)

• Upper Extremity Remote Fugl-Meyer [ Time Frame: Baseline assessment ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
• Upper Extremity Remote Fugl-Meyer [ Time Frame: 2 week assessment ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
• Upper Extremity Remote Fugl-Meyer [ Time Frame: 4 week assessment ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
• Upper Extremity Remote Fugl-Meyer [ Time Frame: 6 week assessment ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
• Upper Extremity Remote Fugl-Meyer [ Time Frame: 8 week assessment ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
• Upper Extremity Remote Fugl-Meyer [ Time Frame: 10 week assessment ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
• Upper Extremity Remote Fugl-Meyer [ Time Frame: 12 week assessment (outcome assessment) ]
  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 25, 2023)

• Motor Activity Log [ Time Frame: Baseline assessment ]
  Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140
• Motor Activity Log [ Time Frame: 12 week completion ]
  Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140
• Gross Grasp Strength [ Time Frame: Baseline assessment ]
  Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs
• Gross Grasp Strength [ Time Frame: 12 week completion ]
  Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
• Official Title: IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial
• Brief Summary: The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).
• Detailed Description: 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 is to develop a system that allows for enhanced functional capability and works consistently over a long-term basis and is accessible remotely no matter location or access to healthcare. In developing a new rehabilitation method, the researchers hope to create a system that allows for closed loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients in response to intended movements of the muscles. The method, if successful, would represent an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors. The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly leaving the realm of science fiction and becoming a realistic goal of the clinical community. The current advances in BCI controlled neuroprosthetics could have immeasurable influence on adult patients with severe motor impairments from stroke. Even further on the horizon the insights developed from such work could substantively alter the way all stroke patients are treated and rehabilitated.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study staff will screen participants virtually or in person for eligibility after completing the informed consent process and documentation. After screening for study eligibility has occurred, the initial EEG screening will take place for all individuals who meet the criteria for the study as to ensure no preference to subjects with optimal signals for use of the IpsiHand. Once EEG screenings have been completed, the participant will be randomly assigned to Group 1 (BCI treatment) or Group 2 (standard of care treatment group). Each group will complete a daily therapy regimen. In Group 1 (BCI group)- will complete daily BCI therapy. In Group 2 (standard of care)- individuals will complete standard of care therapy program daily for 12 weeks provided by an occupational therapist.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Stroke
• Hemiparesis
• Spasticity as Sequela of Stroke
• Brain Computer Interface

Intervention

• Device: Neurolutions IpsiHand System
  The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.
• Other: Standard of Care - Home Exercise Program for Upper Extremity
  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

Study Arms

• Experimental: BCI treatment Group using the IpsiHand

  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.

  Intervention: Device: Neurolutions IpsiHand System
• Experimental: 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. 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.

  Intervention: Other: Standard of Care - Home Exercise Program for Upper Extremity

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 25, 2023): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2025
• Estimated Primary Completion Date: January 10, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Adults age (18-85)
2. Adults who sustained a CVA
3. Have upper extremity hemiparesis/hemiplegia
4. 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:

1. 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.
2. 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.
3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
4. 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.
5. Participants receiving any formal upper extremity therapy will be excluded.
6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
7. Participants who are pregnant or breast-feeding will be excluded.
8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kelly Carr, MOT, OTR/L; 314-272-2575; kcarr@neurolutions.com

Contact: Lauren Souders, MOT, OTR/L; 314-272-2575; lauren@neurolutions.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05965713
• Other Study ID Numbers: National Remote IpsiHand Study
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Neurolutions, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Neurolutions, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Washington University School of Medicine
• Investigators: Not Provided
• PRS Account: Neurolutions, Inc.
• Verification Date: July 2023