Recruiting

TESS vs. Sham TESS

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06950593

Conditions

Upper Limb Hemiparesis Following Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Task Specific Training (TST)

Transcutaneous electrical spinal cord stimulation (TESS)

Sham transcutaneous electrical spinal cord stimulation (Sham TESS)

Study Details

Brief summary:

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.

Conditions

Upper Limb Hemiparesis Following Stroke

Study ID

NCT06950593

Start date

Aug 18, 2025

Status verified date

Aug, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • UE Fugle Meyer Assessment <35
  • not currently receiving regular occupational therapy services
  • participant has received clearance from physician to participate in study
  • participant has at least a rudimentary comprehension of English

Exclusion Criteria:

  • 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
  • unhealed bone fractures
  • severe contractures in the upper extremities
  • active cancer or cancer remission less than 5 years
  • orthopedic dysfunction, injury, or surgery that would impact the individual's ability to use the upper extremities
  • recent procedure or operation of the spinal cord within the past year
  • traumatic brain injury or neurological conditions that would impact the study
  • skull fracture that has developed within the past 6 months
  • non-English speakers

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Experimental Group

This group receives task specific training and transcutaneous spinal cord stimulation (TESS) during treatment sessions. TESS is applied via electrodes placed vertically over the spinous processes of C5-C6. The stimulation will be adjusted within a range of 10mA to 100mA based on participant tolerance and will be delivered for 30 minutes per training session.

active comparator: Comparator Group

This group receives task specific training without real TESS during treatment sessions. Instead, they receive Sham TESS, which is a placebo version in which the electrodes are applied and the stimulation is turned on so that the patient can feel it, and then ramped down to zero for the duration of the session.

Interventions

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.

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.

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.

Primary outcome measure

  • 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 ]
  • 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 ]
  • Grip Strength [ Time Frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Mary Ellen Stoykov, PhD, OT

773-704-2422mstoykov@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Keywords

  • upper limb hemiparesis
  • stroke
  • transcutaneous spinal cord stimulation (TESS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-08-12.