Effect of NMES on Spasticity

NCT07617311 | Not Yet Recruiting

• 1 other identifier: 2026-KAE-0011
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Stroke Spasticity

Keywords

Post-stroke spasticity; Neuromuscular electrical stimulation; Muscle reaction angle; H reflex

Outcome Measures

Primary Outcomes (2)

• Angle of Muscle Reaction

  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.

  From enrollment up to 1 day (Stages 1 and 3) or 2 to 4 days (Stage 2), depending on the assigned stage.

• Hmax / Mmax ratio

  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.

  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.

Study Arms (1)

Neuromuscular electrical stimulation (NMES)

EXPERIMENTAL

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 (intervention) 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. During Phase A, no intervention will be carried out

Device: Neuromuscular electrical stimulation (NMES)

Interventions

Neuromuscular electrical stimulation (NMES) DEVICE

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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Provision of voluntary, written informed consent prior to study enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Katip Çelebi University

Izmir, Karabağlar, 35150, Turkey (Türkiye)

Location

Related Publications (22)

• Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.

  PMID: 26762706 BACKGROUND

• Childers MK, Biswas SS, Petroski G, Merveille O. Inhibitory casting decreases a vibratory inhibition index of the H-reflex in the spastic upper limb. Arch Phys Med Rehabil. 1999 Jun;80(6):714-6. doi: 10.1016/s0003-9993(99)90178-8.

  PMID: 10378501 BACKGROUND

• Katz RT, Rovai GP, Brait C, Rymer WZ. Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil. 1992 Apr;73(4):339-47. doi: 10.1016/0003-9993(92)90007-j.

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• He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.

  PMID: 37475737 BACKGROUND

• Burke D. Clinical uses of H reflexes of upper and lower limb muscles. Clin Neurophysiol Pract. 2016 Apr 7;1:9-17. doi: 10.1016/j.cnp.2016.02.003. eCollection 2016.

  PMID: 30214954 BACKGROUND

• Cameron T, McDonald K, Anderson L, Prochazka A. The effect of wrist angle on electrically evoked hand opening in patients with spastic hemiplegia. IEEE Trans Rehabil Eng. 1999 Mar;7(1):109-11. doi: 10.1109/86.750560.

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• Sentandreu-Mano T, Tomas JM, Ricardo Salom Terradez J. A randomised clinical trial comparing 35 Hz versus 50 Hz frequency stimulation effects on hand motor recovery in older adults after stroke. Sci Rep. 2021 Apr 28;11(1):9131. doi: 10.1038/s41598-021-88607-8.

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• Malhotra S, Rosewilliam S, Hermens H, Roffe C, Jones P, Pandyan AD. A randomized controlled trial of surface neuromuscular electrical stimulation applied early after acute stroke: effects on wrist pain, spasticity and contractures. Clin Rehabil. 2013 Jul;27(7):579-90. doi: 10.1177/0269215512464502. Epub 2012 Nov 5.

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• Schuhfried O, Crevenna R, Fialka-Moser V, Paternostro-Sluga T. Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. J Rehabil Med. 2012 Feb;44(2):99-105. doi: 10.2340/16501977-0941.

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• King TI II. The effect of neuromuscular electrical stimulation in reducing tone. Am J Occup Ther. 1996 Jan;50(1):62-4. doi: 10.5014/ajot.50.1.62. No abstract available.

  PMID: 8644838 BACKGROUND

• Alfieri V. Electrical treatment of spasticity. Reflex tonic activity in hemiplegic patients and selected specific electrostimulation. Scand J Rehabil Med. 1982;14(4):177-82. No abstract available.

  PMID: 6983718 BACKGROUND

• Stowe AM, Hughes-Zahner L, Barnes VK, Herbelin LL, Schindler-Ivens SM, Quaney BM. A pilot study to measure upper extremity H-reflexes following neuromuscular electrical stimulation therapy after stroke. Neurosci Lett. 2013 Feb 22;535:1-6. doi: 10.1016/j.neulet.2012.11.063. Epub 2013 Jan 8.

  PMID: 23313593 BACKGROUND

• Stein C, Fritsch CG, Robinson C, Sbruzzi G, Plentz RD. Effects of Electrical Stimulation in Spastic Muscles After Stroke: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Stroke. 2015 Aug;46(8):2197-205. doi: 10.1161/STROKEAHA.115.009633. Epub 2015 Jul 14.

  PMID: 26173724 BACKGROUND

• Kinnear BZ, Lannin NA, Cusick A, Harvey LA, Rawicki B. Rehabilitation therapies after botulinum toxin-A injection to manage limb spasticity: a systematic review. Phys Ther. 2014 Nov;94(11):1569-81. doi: 10.2522/ptj.20130408. Epub 2014 Jul 24.

  PMID: 25060957 BACKGROUND

• Demetrios M, Khan F, Turner-Stokes L, Brand C, McSweeney S. Multidisciplinary rehabilitation following botulinum toxin and other focal intramuscular treatment for post-stroke spasticity. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009689. doi: 10.1002/14651858.CD009689.pub2.

  PMID: 23740539 BACKGROUND

• McIntyre A, Lee T, Janzen S, Mays R, Mehta S, Teasell R. Systematic review of the effectiveness of pharmacological interventions in the treatment of spasticity of the hemiparetic lower extremity more than six months post stroke. Top Stroke Rehabil. 2012 Nov-Dec;19(6):479-90. doi: 10.1310/tsr1906-479.

  PMID: 23192713 BACKGROUND

• Bakheit AM. The pharmacological management of post-stroke muscle spasticity. Drugs Aging. 2012 Dec;29(12):941-7. doi: 10.1007/s40266-012-0034-z.

  PMID: 23138834 BACKGROUND

• Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21.

  PMID: 20927007 BACKGROUND

• Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.

  PMID: 33978513 BACKGROUND

• Chen B, Yang T, Liao Z, Sun F, Mei Z, Zhang W. Pathophysiology and Management Strategies for Post-Stroke Spasticity: An Update Review. Int J Mol Sci. 2025 Jan 5;26(1):406. doi: 10.3390/ijms26010406.

  PMID: 39796261 BACKGROUND

• Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.

  PMID: 14684785 BACKGROUND

• Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.

  PMID: 15799140 BACKGROUND

Study Officials

• İlker Şengül, M.D.

  İzmir Katip Çelebi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İlker Şengül, M.D.

CONTACT

+905337333698; ilkrsngl@gmail.com

Aleyna Uğurlu, M.D.

CONTACT

+905433466277; aleynaugurlu2000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-case experimental research

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): March 16, 2028
• Study Completion (Estimated): March 16, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)