Electrical stimulation to improve arm function in stroke patients
Upper Limb Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
This study is testing if a new type of electrical stimulation can help stroke patients improve their arm function when combined with specific training exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06950593 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and effects of transcutaneous electrical stimulation of the spinal cord (TESS) combined with task-specific training for individuals with upper limb hemiparesis following a stroke. It compares the outcomes of participants receiving TESS with those receiving a sham stimulation, both undergoing task-specific training. The study aims to recruit 14 chronic post-stroke participants who will complete 15 sessions of their assigned intervention. The goal is to determine if TESS enhances motor control and improves upper limb function compared to standard training alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are at least 6 months post-stroke with moderate to severe upper limb hemiparesis.
Not a fit: Patients with severe contractures, active cancer, or those currently receiving occupational therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb function in stroke survivors with hemiparesis.
How similar studies have performed: Other studies have shown promise with electrical stimulation techniques for stroke rehabilitation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Mary Ellen Stoykov, PhD, OT
- Email: mstoykov@sralab.org
- Phone: 773-704-2422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.