The Effectiveness of Different Pulse Duration of NMES in Patients With Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools

NCT07321158 | Recruiting

• 1 other identifier: 41389/06-05-2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity is a common symptom that affects more than 50% of patients with upper motor neuron lesions due to damage on pyramidal tract. Despite the current pharmacological and physical therapy rehabilitation methods, previous studies have highlighted the beneficial role of Neuromuscular Electrical Stimulation (NMES) on managing upper limb spasticity. However, due to heterogeneity of application parameters there is a lack of a standardized protocol for spasticity management. The aim of the study will be to examine the effects of high versus low pulse duration neuromuscular electrical stimulation on upper limb spasticity on patients with pyramidal tract-related spasticity. A total of 45 patients will be randomized (1:1:1 ratio) to either high pulse duration NMES (HPD-NMES) or low pulse duration NMES (LPD-NMES) or Control group, receiving the standard of care. Randomization will be performed by an independent investigator, who will allocate participants to one of three groups, using a random number generator, prior to baseline assessment. Each group will receive a 15min-conventional-physiotherapeutic protocol. HPD-NMES and LPD-NMES will receive an additional 30min-NMES protocol of high and low pulse duration, respectively. Pre and post intervention spasticity will be evaluated using Range of Motion (ROM) of the elbow joint through electronic goniometer, Modified Ashworth Scale (MAS) and surface electromyography (EMG). Furthermore, Modified Barthel Index (MBI) and 12-version of World Health Organization Disability Assessment Schedule (WHODAs) will be used for evaluating participants' quality of life. Statistical analysis will aim to highlight the effects of NMES both on the EMG-electrophysiological parameters and on clinical evaluation scales. Additionally, it will seek to determine which of the two NMES pulse durations produced more beneficial results in reducing spasticity levels.

Conditions

Pyramidal Tract-related Spasticity; Upper Motor Neuron Lesion

Keywords

spasticity; pyramidal tract; upper motor neuron lesion; electromyography; neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in surface electromyography (EMG) parameters

  1\. Changes in surface electromyography (EMG) parameters (Hoffmann reflex(H-reflex) of the flexor carpi radialis, M wave, F response of the median nerve, Hmax/Mmax ratio (or M/H amplitude ratio), motor unit number estimation (MUNE) and F response of the spastic upper limb).

  Baseline and 6 weeks

Secondary Outcomes (5)

• Modified Ashworth Scale

  Baseline and 6 weeks

• Range Of Motion

  Baseline and 6 weeks

• Modified Barthel Index

  Baseline and 6 weeks

• World Health Organization Disability Assessment Schedule 2.0

  Baseline and 6 weeks

• Changes in biceps brachii diameter (Ultrasound, objective measure)

  Baseline and 6 weeks

Study Arms (3)

High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)

EXPERIMENTAL

Participants will receive 15 minutes Conventional physiotherapy training program (same as control group) and 30 minutes High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)

Device: High Pulse Duration Neuromuscular Electrical Stimulation Group; Other: Usual Care Group

Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)

EXPERIMENTAL

Participants will receive 15 minutes Conventional physiotherapy training program (same as control group) and 30 minutes Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)

Device: Low Pulse Duration Neuromuscular Electrical Stimulation Group; Other: Usual Care Group

Control

OTHER

Patients will receive 15 minute conventional physiotherapy training program that includes seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocepive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment -Bobath (NDT-Bobath) etc)

Other: Usual Care Group

Interventions

Usual Care Group OTHER

Conventional physiotherapy training program * Seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocetive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment- Bobath (NDT-Bobath) etc) * Treatment Duration: 15minutes per session, 3 times per week for 6 weeks total.

Also known as: Control Group

Control; High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES); Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)

High Pulse Duration Neuromuscular Electrical Stimulation Group DEVICE

30 minutes High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES) * NMES Application Parameters: * Waveform: rectangular, biphasic. Symmetrical * Pulse Duration:450μsec * Frequency: 100Hz * Intensity: Optical muscle contraction and patients' tolerability * Ramp up: 2sec * Ramp down:2sec * ON/OFFtime: 10sec/30sec (1:3) * Treatment Duration: 30 minutes per session, 3 times per week for 6 weeks total.

Also known as: HPD-NMES

High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)

Low Pulse Duration Neuromuscular Electrical Stimulation Group DEVICE

30 minutes Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES) * NMES Application Parameters: * Waveform: rectangular, biphasic. Symmetrical * Pulse Duration:100μsec * Frequency: 100Hz * Intensity: Optical muscle contraction and patients' tolerability * Ramp up: 2sec * Ramp down:2sec * ON/OFFtime: 10sec/30sec (1:3) * Treatment Duration: 30 minutes per session, 3 times per week for 6 weeks total.

Also known as: LPD-NMES

Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)

Eligibility Criteria

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

You may qualify if:

• diagnosis by neurologist with first damage of pyramidal tract with upper limb spasticity
• absence of cognitive dysfunction
• normal vital signs

You may not qualify if:

• prior neurological damage to pyramidal tract
• cognitive decline
• dermatological damages
• prior musculoskeletal dysfunction on the upper limb with spasticity
• presence of metallic residues on the spastic upper limb
• presence of seizures or psychiatric disorders
• severe malformation or obesity (BMI \>30kg/m2)
• history of coronary or other cardiovascular diseases (deep vein thrombosis, pulmonary embolism)
• presence of systematic inflammatory disease
• cancer on terminal stages
• pregnancy.

Sponsors & Collaborators

• University of West Attica: lead
• Attikon Hospital: collaborator

Study Sites (1)

Attikon Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (37)

• Chasiotis AK, Giannopapas V, Papadopoulou M, Panagopoulos T, Stasinopoulos D, Giannopoulos S, Bakalidou D. High-Frequency Transcutaneous Electrical Nerve Stimulation in the Management of Pyramidal Tract-Related Spasticity: A Systematic Review. Cureus. 2025 Jun 18;17(6):e86298. doi: 10.7759/cureus.86298. eCollection 2025 Jun.

  PMID: 40688884 BACKGROUND

• Chasiotis A, Giannopapas V, Papadopoulou M, Chondrogianni M, Stasinopoulos D, Giannopoulos S, Bakalidou D. The Effect of Neuromuscular Electrical Nerve Stimulation in the Management of Post-stroke Spasticity: A Scoping Review. Cureus. 2022 Nov 29;14(11):e32001. doi: 10.7759/cureus.32001. eCollection 2022 Nov.

  PMID: 36600817 BACKGROUND

• Kai S, Nakabayashi K. Evoked EMG Makes Measurement of Muscle Tone Possible by Analysis of the H/M Ratio. [Internet]. Electrodiagnosis in New Frontiers of Clinical Research. InTech; 2013; doi: 10.5772/55783.

  BACKGROUND

• Kunoh K, Takenaka T, Kimura D, Suzuki T. Unilateral Vibration Stimulation in Patients With Post-stroke Spasticity Suppresses Muscle Tonus in the Contralateral Homologous Muscles. Cureus. 2025 Aug 31;17(8):e91360. doi: 10.7759/cureus.91360. eCollection 2025 Aug.

  PMID: 41041108 BACKGROUND

• Tekgul H, Polat M, Tosun A, Serdaroglu G, Gokben S. Electrophysiologic assessment of spasticity in children using H-reflex. Turk J Pediatr. 2013 Sep-Oct;55(5):519-23.

  PMID: 24382533 BACKGROUND

• Papavasileiou A, Xenofondos A, Baudry S, Lapole T, Amiridis IG, Metaxiotis D, Tsatalas T, Patikas DA. Protocols Targeting Afferent Pathways via Neuromuscular Electrical Stimulation for the Plantar Flexors: A Systematic Review. Sensors (Basel). 2023 Feb 20;23(4):2347. doi: 10.3390/s23042347.

  PMID: 36850945 BACKGROUND

• Scalia M, Borzuola R, Parrella M, Borriello G, Sica F, Monteleone F, Macaluso A. Neuromuscular electrical stimulation reduces spinal excitability in Multiple Sclerosis patients with spasticity symptoms. Mult Scler Relat Disord. 2025 Jul;99:106457. doi: 10.1016/j.msard.2025.106457. Epub 2025 Apr 19.

  PMID: 40286626 BACKGROUND

• Ferfeli S, Galanos A, Dontas IA, Triantafyllou A, Triantafyllopoulos IK, Chronopoulos E. Reliability and validity of the Greek adaptation of the Modified Barthel Index in neurorehabilitation patients. Eur J Phys Rehabil Med. 2024 Feb;60(1):44-54. doi: 10.23736/S1973-9087.23.08056-5. Epub 2023 Oct 25.

  PMID: 37877957 BACKGROUND

• Papadopoulou, M., Stasi, S., Bakalidou, D. et al. Psychometric Properties of the 12-Item World Health Organization Disability Assessment Schedule (WHODAS 2.0) in Adult Patients with Motor Disabilities. J Dev Phys Disabil 32, 801-819 (2020). https://doi.org/10.1007/s10882-019-09721-0

  BACKGROUND

• Voerman GE, Fleuren JF, Kallenberg LA, Rietman JS, Snoek GJ, Hermens HJ. Patient ratings of spasticity during daily activities are only marginally associated with long-term surface electromyography. J Neurol Neurosurg Psychiatry. 2009 Feb;80(2):175-81. doi: 10.1136/jnnp.2008.147090. Epub 2008 Oct 23.

  PMID: 18948361 BACKGROUND

• Burridge JH, Wood DE, Hermens HJ, Voerman GE, Johnson GR, van Wijck F, Platz T, Gregoric M, Hitchcock R, Pandyan AD. Theoretical and methodological considerations in the measurement of spasticity. Disabil Rehabil. 2005 Jan 7-21;27(1-2):69-80. doi: 10.1080/09638280400014592.

  PMID: 15799144 BACKGROUND

• Nakipoglu Yuzer GF, Kose Donmez B, Ozgirgin N. A Randomized Controlled Study: Effectiveness of Functional Electrical Stimulation on Wrist and Finger Flexor Spasticity in Hemiplegia. J Stroke Cerebrovasc Dis. 2017 Jul;26(7):1467-1471. doi: 10.1016/j.jstrokecerebrovasdis.2017.03.011. Epub 2017 Apr 24.

  PMID: 28462794 BACKGROUND

• He YL, Gao Y, Fan BY. Effectiveness of neuromuscular electrical stimulation combined with rehabilitation training for treatment of post-stroke limb spasticity. Medicine (Baltimore). 2019 Sep;98(39):e17261. doi: 10.1097/MD.0000000000017261.

  PMID: 31574840 BACKGROUND

• Allen, K., Goodman, C. Using Electrical Stimulation: A Guideline for Allied Health Professionals [Internet]. New South Wales, Australia: Sydney Local Health District and Royal Rehabilitation Centre; 2014. Report No.: Clinical Guideline; https://www.alliedhealthsupport.com/wp-content/uploads/2019/03/Using-Electrical-Stimulation_A-guideline-for-allied-health-professionals-January-2014.pdf

  BACKGROUND

• Doucet BM, Lam A, Griffin L. Neuromuscular electrical stimulation for skeletal muscle function. Yale J Biol Med. 2012 Jun;85(2):201-15. Epub 2012 Jun 25.

  PMID: 22737049 BACKGROUND

• Nussbaum EL, Houghton P, Anthony J, Rennie S, Shay BL, Hoens AM. Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Physiother Can. 2017;69(5):1-76. doi: 10.3138/ptc.2015-88.

  PMID: 29162949 BACKGROUND

• Hsu SS, Hu MH, Luh JJ, Wang YH, Yip PK, Hsieh CL. Dosage of neuromuscular electrical stimulation: is it a determinant of upper limb functional improvement in stroke patients? J Rehabil Med. 2012 Feb;44(2):125-30. doi: 10.2340/16501977-0917.

  PMID: 22266658 BACKGROUND

• Reed B. The Physiology of Neuromuscular Electrical Stimulation: Pediatr Phys Ther. 1997;9(3):96???102; doi: 10.1097/00001577-199700930-00002.

  BACKGROUND

• Castel-Lacanal E. Sites of electrical stimulation used in neurology. Ann Phys Rehabil Med. 2015 Sep;58(4):201-207. doi: 10.1016/j.rehab.2015.05.004. Epub 2015 Jul 14.

  PMID: 26183200 BACKGROUND

• Amiridis IG, Mani D, Almuklass A, Matkowski B, Gould JR, Enoka RM. Modulation of motor unit activity in biceps brachii by neuromuscular electrical stimulation applied to the contralateral arm. J Appl Physiol (1985). 2015 Jun 15;118(12):1544-52. doi: 10.1152/japplphysiol.00031.2015. Epub 2015 Apr 30.

  PMID: 25930023 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

• Xie T, Leng Y, Zhi Y, Jiang C, Tian N, Luo Z, Yu H, Song R. Increased Muscle Activity Accompanying With Decreased Complexity as Spasticity Appears: High-Density EMG-Based Case Studies on Stroke Patients. Front Bioeng Biotechnol. 2020 Nov 16;8:589321. doi: 10.3389/fbioe.2020.589321. eCollection 2020.

  PMID: 33313042 BACKGROUND

• 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

• Clair-Auger JM, Collins DF, Dewald JP. The effects of wide pulse neuromuscular electrical stimulation on elbow flexion torque in individuals with chronic hemiparetic stroke. Clin Neurophysiol. 2012 Nov;123(11):2247-55. doi: 10.1016/j.clinph.2012.04.024. Epub 2012 May 22.

  PMID: 22627022 BACKGROUND

• 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.

  PMID: 23129814 BACKGROUND

• Sahin N, Ugurlu H, Albayrak I. The efficacy of electrical stimulation in reducing the post-stroke spasticity: a randomized controlled study. Disabil Rehabil. 2012;34(2):151-6. doi: 10.3109/09638288.2011.593679. Epub 2011 Oct 15.

  PMID: 21999668 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

• Takeda K, Tanino G, Miyasaka H. Review of devices used in neuromuscular electrical stimulation for stroke rehabilitation. Med Devices (Auckl). 2017 Aug 24;10:207-213. doi: 10.2147/MDER.S123464. eCollection 2017.

  PMID: 28883745 BACKGROUND

• Huang Y, Nam C, Li W, Rong W, Xie Y, Liu Y et al. A comparison of the rehabilitation effectiveness of neuromuscular electrical stimulation robotic hand training and pure robotic hand training after stroke: A randomized controlled trial. Biomedical Signal Processing and Control. 2020 Feb;56:101723. doi: 10.1016/j.bspc.2019.101723

  BACKGROUND

• Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.

  PMID: 17299744 BACKGROUND

• Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.

  PMID: 22984012 BACKGROUND

• Picelli A, Tamburin S, Gajofatto F, Zanette G, Praitano M, Saltuari L, Corradini C, Smania N. Association between severe upper limb spasticity and brain lesion location in stroke patients. Biomed Res Int. 2014;2014:162754. doi: 10.1155/2014/162754. Epub 2014 May 25.

  PMID: 24963473 BACKGROUND

• Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.

  PMID: 7192811 BACKGROUND

• Lohia A, McKenzie J. Neuroanatomy, Pyramidal Tract Lesions. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540976/

  PMID: 31082020 BACKGROUND

• Cho MJ, Yeo SS, Lee SJ, Jang SH. Correlation between spasticity and corticospinal/corticoreticular tract status in stroke patients after early stage. Medicine (Baltimore). 2023 Apr 25;102(17):e33604. doi: 10.1097/MD.0000000000033604.

  PMID: 37115067 BACKGROUND

• Lee D, Song J, Kim JW, Ahn TB. Spasticity secondary to isolated involvement of the pyramidal tract. J Neurol Sci. 2016 Sep 15;368:130-1. doi: 10.1016/j.jns.2016.06.072. Epub 2016 Jul 1. No abstract available.

  PMID: 27538615 BACKGROUND

• de Oliveira-Souza R. Damage to the pyramidal tracts is necessary and sufficient for the production of the pyramidal syndrome in man. Med Hypotheses. 2015 Jul;85(1):99-110. doi: 10.1016/j.mehy.2015.04.007. Epub 2015 Apr 29.

  PMID: 25959865 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Athanasios K. Chasiotis, Physiotherapist

CONTACT

+306973257982; thanosch1@gmail.com , achasiotis@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc, PHDc

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 6, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)