What this study is
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.
What's being tested
- Task Specific Training (TST)
Intervention · 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)
Intervention · 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)
Intervention · 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
- Official title
- Upper Limb Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
- Sponsor
- Shirley Ryan AbilityLab
- Conditions
- Upper Limb Hemiparesis Following Stroke
- Enrolling
- 14 people
- Starts
- 2025-08-18
- Est. completion
- 2027-01-01
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openShirley Ryan AbilityLab
Chicago, Illinois, United States
Recruiting
Study team
Sponsor
Shirley Ryan AbilityLab
Study ID STU00220717
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.