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NCT07669649
Effect of TENS on Spasticity
Conditions: Post Stroke Spasticity
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 4
Sponsor: Izmir Katip Celebi University
Location: Izmir Katip Çelebi University Izmir Karabağlar
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.
Eligibility Criteria
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 \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 to compromise adherence to study protocols
* Inability to maintain the required testing positions for the upper extremity joints (shoulder, elbow, forearm, and wrist)
* Pregnancy or breastfeeding
* Presence of active malignancy at or near the treatment area.
Source: ClinicalTrials.gov (NCT07669649). StuddyBuddy aggregates publicly available trial information.