Remote therapy using the IpsiHand device for stroke recovery

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

This study is testing whether a new remote therapy using a robotic hand can help people who have had a stroke improve their movement better than regular home exercises.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Neurolutions, Inc. (Industry-sponsored)
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT05965713 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a fully remote brain-computer interface (BCI) therapy using the IpsiHand device for patients with chronic hemiparetic stroke. Participants will be randomly assigned to receive either the BCI-controlled robotic hand exoskeleton or standard home exercise therapy to assess improvements in motor function. The study focuses on creating a long-term, accessible rehabilitation method that utilizes closed-loop feedback to enhance motor learning and recovery. By leveraging advances in neuroprosthetics, the researchers hope to significantly improve the rehabilitation process for stroke survivors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have experienced a cerebrovascular accident and have upper extremity hemiparesis.

Not a fit: Patients with severe cognitive impairments or those with contractures in the affected wrist and digits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to significant improvements in motor function for stroke patients, enhancing their quality of life.

How similar studies have performed: Other studies have shown promise in using BCI technology for rehabilitation, but this specific remote approach with the IpsiHand device is relatively novel.

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.

Where this trial is running

Saint Louis, Missouri

• Neurolutions — Saint Louis, Missouri, United States (Recruiting)

Study contacts

• Study coordinator: Kelly Carr, MOT, OTR/L

Conditions Stroke; Hemiparesis; Spasticity as Sequela of Stroke; Brain Computer Interface; Neurolutions; IpsiHand