NCT07669649Not yet recruiting
Effect of TENS on Spasticity
The Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity: A Single-Subject Experimental Study
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- First submitted
- 20 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Izmir Katip Celebi University
- Diseases
- Stroke
- NCT number
- NCT07669649
What you commit to
- Study type: Interventional
- Planned participants: 4
- From 1 Jun 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant wrist contracture or pain sufficient to impede clinical evaluation
- 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
Other illness
- Contraindications to transcutaneous electrical nerve stimulation (e.g., implanted electronic devices, history of epilepsy, or localized skin lesions preventing electrode placement)
- 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 to compromise adherence to study protocols
- Presence of active malignancy at or near the treatment area.
Age
- Age \<18 or \>70 year
Other
- Structural abnormalities of the elbow joint obstructing median nerve stimulation
- Median nerve neuropathy or injury in the affected upper extremity.
- Botulinum toxin injection in the target spastic muscles within the preceding 3 months
- Inability to maintain the required testing positions for the upper extremity joints (shoulder, elbow, forearm, and wrist)
- Pregnancy or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Izmir Katip Çelebi University Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.