Effect of TENS on Spasticity (NCT07669649) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of TENS on Spasticity
Turkey (Türkiye)4 participantsStarted 2026-06
Plain-language summary
The purpose of this clinical trial is to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing spasticity in adults with post-stroke spasticity. The primary research question is whether TENS can reduce the severity of spasticity. The effectiveness of TENS will be assessed by comparing spasticity-related outcomes measured before, during, and after the intervention. Participants will first undergo a one-hour baseline monitoring period, during which assessments will be conducted at 10-minute intervals. This will be followed by a 30-minute TENS intervention and a two-hour follow-up period, with assessments performed every 10 minutes. One participant will repeat this protocol once daily for three consecutive days, whereas the remaining three participants will undergo the procedure on a single occasion.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 70 years
* Post-stroke wrist flexor spasticity scored as Grade 2 or 3 on the Australian Spasticity Assessment Scale (ASAS), specifically selecting patients whose passive stretch resistance (post-catch response) can be easily overcome to ensure accurate and unconfounded electrophysiological evaluation.
* At least 6 months post-stroke (chronic phase).
* Provision of voluntary, written informed consent prior to study enrollment.
Exclusion Criteria:
* Age \<18 or \>70 year
* Contraindications to transcutaneous electrical nerve stimulation (e.g., implanted electronic devices, history of epilepsy, or localized skin lesions preventing electrode placement)
* Concomitant wrist contracture or pain sufficient to impede clinical evaluation
* Structural abnormalities of the elbow joint obstructing median nerve stimulation
* Median nerve neuropathy or injury in the affected upper extremity.
* Non-stable dosage of antispastic medications within the 2 weeks prior to baseline
* Initiation of medications affecting nerve conduction (e.g., antidepressants, anticonvulsants, anesthetics) within the past month; patients on a stable dose for \>1 month remain eligible
* Botulinum toxin injection in the target spastic muscles within the preceding 3 months
* History of neurolytic procedures targeting spasticity in the affected limb.
* History of orthopedic or neurological surgery targeting spasticity in the affected limb
* Cognitive impairment severe enough t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Angle of Muscle Reaction
Timeframe: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
2
Hmax / Mmax ratio
Timeframe: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).