Effect of NMES on Spasticity

NCT07617311 · tracked via the Priya Life Science Turkey tracker

Sponsor

Izmir Katip Celebi University

Phase

Not applicable

Started

2026-06-15

Last updated

2026-06-03

Condition(s) studied

Post-Stroke Spasticity

Investigational drug(s) / intervention(s)

Neuromuscular electrical stimulation (NMES)Neuromuscular electrical stimulation (NMES)

Neuromuscular electrical stimulation (NMES): Neuromuscular electrical stimulation (NMES) (a symmetric, biphasic, rectangular waveform) will be administered to the antagonist wrist extensors (extensor carpi radialis longus/brevis and extensor carpi ulnaris) of the spastic wrist flexors in the B phase. The configuration consists of an application duration of 20 minutes, a stimulation frequency of 35 Hz, and a pulse duration of 300 μs. The duty cycle will feature a 20-second ON time and 20-second OFF time (1:1 ratio), with ramp-up and ramp-down durations set at 5 seconds.

Neuromuscular electrical stimulation (NMES): Neuromuscular electrical stimulation (NMES) is a therapeutic modality used in neurorehabilitation. By delivering transcutaneous electrical currents, NMES elicits repetitive, patterned muscle contractions to augment or restore motor functions.

Study summary

The goal of this clinical trial is to learn if neuromuscular electrical stimulation (NMES) works to treat spasticity in adult patients with spasticity related to stroke. The main question it aims to answer is:

• Does NMES reduces the severity of spasticity? Researchers will compare NMES treatment to baseline and non-stimulation periods to see if NMES works to treat spasticity.

Participants will:

• first undergo an initial assessment at 10-minute intervals for one hour, followed by 20 minutes of NMES exposure, and subsequent post-treatment assessments at 10-minute intervals for two hours. This daily procedure will be repeated over four days for one patient, and performed only once for the remaining three patients.

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. * Provision of voluntary, written informed consent prior to study enrollment. Exclusion Criteria: * Age \<18 or \>70 year * Contraindications to neuromuscular electrical stimulation (e.g., active electronic implants, 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 ipsilateral 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 infiltration 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

Primary outcome measure(s)

Angle of Muscle Reaction — From enrollment up to 1 day (Stages 1 and 3) or 2 to 4 days (Stage 2), depending on the assigned stage.
The Angle of Muscle Reaction is the specific joint angle at which a catch response is elicited in the target muscles (flexor carpi radialis and flexor carpi ulnaris) during a passive stretch delivered at the highest possible velocity.
Hmax / Mmax ratio — From enrollment to the completion of treatment, varying by stage: 1 day for Stages 1 and 3, and 2 to 4 days for Stage 2.
The Hmax / Mmax ratio serves as an objective electrophysiological index of spinal motor neuron pool excitability. Although it does not directly measure velocity-dependent mechanical resistance, this neurophysiological marker quantifies spinal hyperexcitability, thereby providing a critical adjunct to subjective clinical scales.

Trial sites (1)

Facility	City	Region	Status
İzmir 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 NCT07617311 on ClinicalTrials.gov ↗ ← All trials in Turkey