Transcutaneous Electrical Stimulation for Stroke Patients

Conditions

• Upper Limb Hemiparesis Following Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Task Specific Training (TST) — OTHER
  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
  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
  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.

Study Details

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.

Key Dates

Start date

Aug 18, 2025

Status verified

Aug 2025

Primary completion

Jun 1, 2026

Completion

Jan 1, 2027

Study Design

Enrollment

14 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• Mary Ellen Stoykov, PhD, OT
  773-704-2422
  [email protected]

Locations (1)

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