Effect of TENS on Spasticity

Starting soon · Not applicable

Conditions studied: Post Stroke Spasticity

In brief

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.

Key facts

Study ID

NCT07669649

Run by

Izmir Katip Celebi University

People needed

4

Starts

2026-06-01

Expected to finish

2027-06-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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.

Where it is running

• Izmir Katip Çelebi University — Izmir, Karabağlar, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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