NCT05811806

Physiological Changes From Hand Movement Training

Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: IRegained Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

11 participants with upper-limb impairment will be recruited from community sources. They will be invited to participate in a 15-day trial involving the IRegained device. The study will involve 2 assessment visits to Baycrest, before and after the treatment, and 15 treatment visits. The data from the pilot study will be analyzed both quantitatively and qualitatively, as outcomes and explicit feedback from participants will be used to further optimize the device for future studies.

Detailed description

This pilot study will investigate the potential changes in the brain area controlling hand movement following 15 days of exercises to improve hand function in participants with upper limb impairments resulting from stroke. A device developed by Dr. Vineet Johnson (IRegained Inc.) will be used to administer standardized exercises to improve hand function. To assess brain changes, transcranial magnetic stimulation pulses will be delivered to the motor cortex. The motor evoked potential (MEP), a muscle response evoked from the TMS, will be measured using electrodes on the hand. This study will test the feasibility of conducting motor therapy using this device while assessing potential changes in motor cortex function. Findings from this study will contribute to developing treatment trials aimed at improving impaired limb function in stroke patients and quality of life in these individuals

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Treatment using the MyHand System	Participants will undergo three weeks of 1-hour hand therapy with the MyHand System. The MyHand System provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy.

Timeline

• Start date: 2022-05-02
• Primary completion: 2022-08-04
• Completion: 2022-08-04
• First posted: 2023-04-13
• Last updated: 2023-04-13

Locations

1 site across 1 country: Canada