Effect of TENS on Spasticity

NCT07669649 · tracked via the Priya Life Science Turkey tracker

Sponsor

Izmir Katip Celebi University

Phase

Not applicable

Started

2026-06

Last updated

2026-06-25

Condition(s) studied

Post Stroke Spasticity

Investigational drug(s) / intervention(s)

Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve stimulation (TENS) will be applied over the projection area of the paretic wrist flexor muscles (flexor carpi radialis) for 30 minutes. Stimulation parameters will consist of symmetrical biphasic rectangular pulses at a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to produce a clearly perceived sensory sensation without visible muscle contraction or discomfort.

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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 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.

Primary outcome measure(s)

Angle of Muscle Reaction — From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
The Angle of Muscle Reaction (AMR) is defined as the joint angle at which a catch response is elicited in the wrist flexor muscles (flexor carpi radialis and flexor carpi ulnaris) during passive stretch performed at the highest achievable velocity. Higher values indicate lower spasticity.
Hmax / Mmax ratio — From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
The Hmax/Mmax ratio is an electrophysiological measure of spinal motor neuron excitability obtained from flexor carpi radialis H-reflex recordings. Higher values indicate greater spinal motor neuron excitability.

Trial sites (1)

Facility	City	Region	Status
Izmir Katip Çelebi University	Izmir	Karabağlar

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07669649 on ClinicalTrials.gov ↗ ← All trials in Turkey