Health TrialsbyHealthPanel

Transcutaneous Electrical Stimulation for Stroke Patients

ConditionUpper Limb Hemiparesis Following Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShirley Ryan AbilityLab

About this trial

This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

able and willing to give written consent and comply with study procedures

at least 6 months post-stroke

hemiplegia secondary to stroke

Disqualifiers

botox injection in upper extremity within the last 4 months

modified ashworth score of 4 in any joint of the affected limb

pregnant or nursing

using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants

Trial design

Design model

Parallel

Treatments tested in this trial

  • Task Specific Training (TST)

    Other intervention

    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.

  • Transcutaneous electrical spinal cord stimulation (TESS)

    Other intervention

    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.

  • Sham transcutaneous electrical spinal cord stimulation (Sham TESS)

    Other intervention

    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.

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Experimental GroupActive comparator 2 interventions
Group B: Comparator GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Fugl-Meyer Test of Upper Extremity Function (FMUE)

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.

Time frame
Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
2

Modified Ashworth Scale (MAS)

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.

Time frame
Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
3

Grip Strength

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.

Time frame
Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
4

Chedoke Arm & Hand Activity Index (CAHAI-9)

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.

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

Secondary outcomes

1

Motor evoked potential status (MEPs)

MEP status is a binary TMS stimulation measure for evaluation of the treatment target or, in this study, corticospinal excitability. There will be an attempt to elicit active MEPs in the biceps, ECR, and FDI. The MEP status of each of the 3 muscles will be tested by finding a hot spot using a single pulse TMS. Individual muscles will be labeled as MEP(-) or MEP(+). The criteria for being MEP(+) is any amplitude present in at least 50% (5/10) of the TMS stimuli using stimulation up to 100% maximal stimulator output.

Time frame
Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
2

Maximum Voluntary Contraction (MVC)

Electromyographic (EMG) recordings will be recorded through surface electrodes secured to th skin over the belly of each muscle. In order to obtain MVCs of each affected upper limb muscle, subjects will perform three contractions of elbow flexion, wrist extension, and finger abduction individually. MVCs will be recorded for 3-5s, separated by \~60s of rest.

Time frame
Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
3

H-reflex

The H-reflex is used to assess the reflexive reaction of the flexor carpi radialis muscle after stimulating the sensory nerve (Ia afferent) fibers. Percutaneous electrical stimulation of the median nerve will be delivered (using 1 ms rectangular electrical stimulus, DS7AH, Digitimer Ltd.) through bipolar electrodes (7-mm stainless steel) just proximal to the elbow. Stimulus intensities will be increased in steps of 0.05 mA, starting below H-reflex threshold and increasing up to measure the H-max and M-max at rest (0.25 Hz). The H-max and Mmax will be measured as peak-to-peak amplitude of the non-rectified response in control subjects and both arms of individuals.

Time frame
Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Source ClinicalTrials.gov
Apply now