Effect of TENS on Spasticity

NCT07669649 | Not Yet Recruiting

• 1 other identifier: 2026-KAE-0019
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Stroke Spasticity

Keywords

Post stroke spasticity; Transcutaneous electrical nerve stimulation; Muscle reaction angle; H reflex

Outcome Measures

Primary Outcomes (2)

• Angle of Muscle Reaction

  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.

  From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).

• Hmax / Mmax ratio

  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.

  From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).

Study Arms (1)

Transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

Participants with chronic post-stroke wrist flexor spasticity will receive sensory-level transcutaneous electrical nerve stimulation (TENS) applied over the paretic wrist flexor muscles during the intervention (B) phase. TENS will be delivered for 30 minutes using a symmetrical biphasic rectangular waveform with a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort. During the baseline (A) phase, no intervention will be administered.

Device: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

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.

Transcutaneous electrical nerve stimulation (TENS)

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.
• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University

Izmir, Karabağlar, 35150, Turkey (Türkiye)

Location

Related Publications (17)

• Lance JW. Symposium synopsis. In: Feldman RG, Young RR, Koella WP, editors. Spasticity: Disordered Motor Control. Chicago: Year Book Medical Publishers; 1980. p. 485-494.

  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

• Tate RL, Perdices M. Introduction to single-case experimental designs: historical overview and basic concepts. In: Tate RL, Perdices M, editors. Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings: Planning, Conduct, Analysis and Reporting. New York: Routledge; 2019. p. 3-20.

  BACKGROUND

• 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

• 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.

  PMID: 1554307 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

• 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

• 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

• Fernandez-Tenorio E, Serrano-Munoz D, Avendano-Coy J, Gomez-Soriano J. Transcutaneous electrical nerve stimulation for spasticity: A systematic review. Neurologia (Engl Ed). 2019 Sep;34(7):451-460. doi: 10.1016/j.nrl.2016.06.009. Epub 2016 Jul 26. English, Spanish.

  PMID: 27474366 BACKGROUND

• Mahmood A, Veluswamy SK, Hombali A, Mullick A, N M, Solomon JM. Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity in Adults With Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):751-768. doi: 10.1016/j.apmr.2018.10.016. Epub 2018 Nov 16.

  PMID: 30452892 BACKGROUND

• Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.

  PMID: 17964875 BACKGROUND

• Levin MF, Hui-Chan CW. Relief of hemiparetic spasticity by TENS is associated with improvement in reflex and voluntary motor functions. Electroencephalogr Clin Neurophysiol. 1992 Apr;85(2):131-42. doi: 10.1016/0168-5597(92)90079-q.

  PMID: 1373366 BACKGROUND

• Lazorthes Y, Sol JC, Sallerin B, Verdie JC. The surgical management of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:35-41; dicussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1035.x.

  PMID: 11918648 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

• 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

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Korhan B Bayram

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Korhan B Bayram, M.D.

CONTACT

+905073066695; korbay@gmail.com

Büşra Candal, M.D.

CONTACT

+905436940747; busraalpppp@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: June 20, 2026
• First Posted: June 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)