Clinical trial NCT05811806: Physiological Changes From Hand Movement Training
Official title: Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: IRegained Inc.
Sponsor class: INDUSTRY
Collaborators: name: Baycrest
name: McMaster University
First posted: 2023-04-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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 24 or less).
* Botox Injections less than 2 months prior to starting the study

Primary outcomes:
measure: Action Research Arm Test (ARAT)- Change is being assessed
timeFrame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
measure: ABILHAND- Change is being assessed
timeFrame: Baseline- before beginning the treatment, and Post- after the completion of 15 treatment sessions, within 5 days
measure: Box and Block Test (BBT)- Change is being assessed
timeFrame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Secondary outcomes:
measure: Finger Goniometry- Change is being assessed
timeFrame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
measure: Grip Dynamometry- Change is being assessed
timeFrame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
measure: Pinch Dynamometry- Change is being assessed
timeFrame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Other outcomes:
Locations:
city: North York
country: Canada
facility: Baycrest Hospital
state: Ontario
Study officials:
affiliation: Baycrest Hospital
name: Jed Meltzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: