Hand Training & Brain Changes

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

10 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 McMaster, 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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hand Function
• Intervention / Treatment: Device: Treatment using the MyHand System

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

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ravjot Rehsi, MSc; Phone Number: 9052996418; Email: rehsir@mcmaster.ca
• Study Contact Backup: Name: Mikayla Marshall; Phone Number: 2898088821; Email: mikayla@iregained.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Recruiting
      • Aimee Nelson
      • Contact: Mikayla Marshall; Phone Number: 2898088821; Email: mikayla@iregained.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Sustained a single stroke >6months prior to start of study

Exclusion Criteria:

• Severe spasticity or contractures (2 or less in the CMSA)
• any other musculoskeletal or neuromuscular disorders that compromise sensation
• Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 23 or less).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neurorehabilitation of the Hand; Participants will undergo a 1-hour training session 5 days per week, over 3 weeks for a total of 15 sessions. Hand function therapy will be administered using the gamified protocol to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessed	a 9-item assessment, will be performed by a trained clinician to estimate a participants functional ability during the initial assessment. The CAHAI-9 requires a participant to perform 9 bimanual ADLs, each of which will be scored on a 7 point scale.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
ABILHAND- Change is being assessed	a subjective functional assessment tool will be used. The tool is a 23-item survey, and participants are provided with a list of various everyday functional tasks and are scored based on patient response. For example, participant will be asked whether it is 'easy', 'difficult' or 'impossible' for each of the 23 tasks.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Box and Block (BBT)- Change is being assessed	The BBT requires participants to move cubical wooden blocks over a partition from one box to another. Grip and pinch dynamometry will be used to assess a participant's hand strength.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finger Goniometry- Change is being assessed	Estimate range of motion (ROM) of the various finger joints.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Grip Dynamometry- Change is being assessed	Measures participants grip strength	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Pinch Dynamometry- Change is being assessed	Measures participants pinch strength	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

Collaborators and Investigators

• Sponsor: IRegained Inc.
• Collaborators: McMaster University; Baycrest
• Investigators: Principal Investigator: Aimee Nelson, PhD, McMaster University; Study Director: Jed Meltzer, PhD, Baycrest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Anticipated): July 9, 2023
• Study Completion (Anticipated): July 9, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Motor control; Neurorehabilitation; stroke rehabilitation; Hand Function; Hand Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: BHMU0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No