Transcutaneous Electrical Stimulation for Stroke Patients

OTHER

Task Specific Training (TST)

Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping.

OTHER

Transcutaneous electrical spinal cord stimulation (TESS)

The Digitimer DS8R Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation. The stimulus intensity used during the intervention will be determined based on individual maximum tolerance. We expect this current amplitude to be between 10mA and 100mA. Stimulation time will be standardized to a 30min duration during which the participant will perform task specific training tasks.

OTHER

Sham transcutaneous electrical spinal cord stimulation (Sham TESS)

The Sham TESS intervention will utilize the same device and setup as the true TESS intervention. However, after turning on the stimulation and reaching the appropriate intensity, the stimulation will be ramped down and turned off for the remainder of the treatment session. The participant will be told that the stimulation was brought down to a sub-threshold level in order to maintain treatment group blinding.

Fugl-Meyer Test of Upper Extremity Function (FMUE)

Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation

The FMUE is an impairment scale that addresses both synergy and isolated movements of the upper limb. The subscales include reflex movements, flexor synergy, extensor synergy, movements out of synergy, combining synergies, wrist, hand, and coordination subscales. The total score ranges from 0 to 66 with higher scores indicating greater function.

Modified Ashworth Scale (MAS)

Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation

The MAS is a test of muscle spasticity and increases in muscle tone. The scores range from 0-4 for each test item, depending on the increase in muscle tone when completing quick movement, or resting muscle tone.

Grip Strength

Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation

Grip strength will be an outcome measure measured via the Jamar Dynamometer. The procedure will consist of 3 tests of maximum grip strength force. Participants will be given \~30 seconds to 1 minute of rest time for each hand in between tests. The individual will maintain \~90 degrees of elbow flexion, 0 degrees of shoulder flexion, and a neutral wrist position while completing the testing.

Chedoke Arm & Hand Activity Index (CAHAI-9)

Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation

The CAHAI 9 is a test of bimanual function. There are nine activities including opening a jar, pouring water, drawing a line with a ruler, buttoning a shirt, using the telephone, wringing out a washcloth, applying toothpaste to a toothbrush, cutting food, and drying one's back with a bath towel. The scale ranges from 1 to 7 for each test item and are graded by the amount of use of the affected hand.

Canadian Occupational Performance Measure (COPM)

Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation

The COPM is a patient-reported outcome measure in which the participant will be asked to rate their ability to perform tasks of everyday living. Specifically, the assessment asks participants to identify tasks that they find value in completing, rank their priority, and rank their ability to perform them.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.