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Pyramidal Tract-related SpasticityPD-NMES-SPASNCT07321158

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

A study testing High Pulse Duration Neuromuscular Electrical Stimulation Group and Low Pulse Duration Neuromuscular Electrical Stimulation Group in people with Pyramidal Tract-related Spasticity and Upper Motor Neuron Lesion, run by University of West Attica at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High Pulse Duration Neuromuscular Electrical Stimulation Group and Low Pulse Duration Neuromuscular Electrical Stimulation Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteGreece
Study dates
6 Jan 2026to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis by neurologist with first damage of pyramidal tract with upper limb spasticity
  • absence of cognitive dysfunction
  • normal vital signs
  • absence of pharmacological treatment of spasticity (per os pharmacological treatment does not affect spasticity results and was not an exclusion criteria on patients' recruitment).

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Attikon Hospital

    Athens, Attica, 12462

Other trials in Greece

About this study

Official title: The Effectiveness of High Versus Low Pulse Duration Neuromuscular Electrical Stimulation (NMES) in Patients With Upper Limb Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools: A Randomized Controlled Trial

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.

Read the detailed description

Spasticity can be characterized as a clinical phenotype related to upper motor neuron syndrome and is highly correlated with pyramidal tract lesions, leading to patients' quality of life degradation. The assessment of spasticity encompasses both clinical rating scales (such as Modified Ashworh Scale, Modified Tardieu Scale and Composite Spasticity Scale) and neurophysiological approaches through surface electromyography (such as Hoffmann reflex (H-reflex) , Mwave, and Hmax/Mmax ratio (or M/H amplitude ratio), which seem to be elevated in spasticity. A wide spectrum of therapeutic modalities, including pharmacological and non-pharmacological interventions, have been developed for the management of spasticity. Among non-pharmacological interventions, physical therapy through Neuromuscular Electrical Stimulation can be used to manage upper and lower limb spasticity through the reduction of stretch reflex excitability, facilitation reciprocal inhibition and spinal excitability modulation.

This randomized controlled trial consists of:

  • Participants randomization into one control group (group A, n=15) and two intervention groups: group B (High Pulse Duration Neuromuscular Electrical Stimulation/HPD-NMES, n=15), group C (Low Pulse Duration Neuromuscular Electrical Stimulation/LPD-NMES, n=15).
  • Conventional Physiotherapy training program for 15 minutes per session, 3 times per week for 6 weeks total (groups A, B,C) and Neuromuscular Electrical Stimulation protocol for 30 minutes per session, 3 times per week for 6 weeks total (Group B=HPD-NMES and Group C=LPD-NMES)
  • Primary spasticity evaluation tool at baseline and post intervention (6weeks) through surface electromyography.
  • Secondary spasticity evaluation tools (Modified Ashworth Scale/MAS, Range of Motion/ROM, Modified Barthel Index/MBI and 12 version World Health Organization Disability Assessment Schedule 2.0/ WHODAS 2.0) at baseline and post-intervention (6 weeks).

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.

Being tested
High Pulse Duration Neuromuscular Electrical Stimulation Group, Low Pulse Duration Neuromuscular Electrical Stimulation Group, Usual Care Group
Keywords
spasticity, pyramidal tract, upper motor neuron lesion, electromyography, neuromuscular electrical stimulation
Medical subject headings
Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Pulse Duration Neuromuscular Electrical Stimulation GroupDevice

    Also called HPD-NMES

    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.

  • Low Pulse Duration Neuromuscular Electrical Stimulation GroupDevice

    Also called LPD-NMES

    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.

  • Usual Care GroupOther

    Also called Control Group

    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.
Study groups in NCT07321158
Study groupRoleWhat they receive
High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)ExperimentalParticipants will receive 15 minutes Conventional physiotherapy training program (same as control group) and 30 minutes High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)
Receives: Device: High Pulse Duration Neuromuscular Electrical Stimulation Group; Other: Usual Care Group
Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)ExperimentalParticipants will receive 15 minutes Conventional physiotherapy training program (same as control group) and 30 minutes Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)
Receives: Device: Low Pulse Duration Neuromuscular Electrical Stimulation Group; Other: Usual Care Group
ControlOtherPatients 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)
Receives: Other: Usual Care Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and 6 weeks

Secondary outcomes (5)

  1. Modified Ashworth Scale

    1. Changes in Modified Ashworth Scale (MAS) scores. A 5-item evaluation scale that assessed muscle hypertonia. The minimum score is 0 (normal muscle tone) and the maximum is 4 (limb rigid). Higher scores indicate increase in spasticity.

    Measured: Baseline and 6 weeks

  2. Range Of Motion

    Changes in Range of Motion (ROM) scores: The assessment will be conducted using an electronic goniometer to precisely determine the range of motion of the elbow joint affected by spasticity. Patients will be positioned in the supine position on the examination table with the affected side oriented toward the examiner. Then, the examiner will align the goniometer with anatomical landmarks the base of the goniometer over the lateral epicondyle of the humerus, the stable axis along the humerus and the movable axis along the radius. The angle of the elbow-flexion will be recorded, and the measured value will be substracted from 145o (the range of motion of a full elbow flexion) in order to calculate elbow extension. Decreases in elbow extension scores indicate reduction in spasticity levels.

    Measured: Baseline and 6 weeks

  3. Modified Barthel Index

    Changes in Modified Barthel Index (MBI) scores. Modified Barthel Index is an evaluation scale that assesses patient's performance in activities of daily living. It consists of 10 domains with activities of daily living and mobility. Greater scores are correlated with decreased level of dependence

    Measured: Baseline and 6 weeks

  4. World Health Organization Disability Assessment Schedule 2.0

    Changes in 12 version World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) scores: WHODAS 2.0 is an evaluation scale that assesses perceived disability associated with the health condition in the 30 days preceding its application. Is divided into six domains: i) cognition, ii) mobility, iii) self-care, iv) interpersonal relationships, v) activities of daily living and vi) participation. Each item is rated from 1 (no difficulty) to 5 (extreme difficulty or unable to do). Larger scores refer to larger disability.

    Measured: Baseline and 6 weeks

  5. Changes in biceps brachii diameter (Ultrasound, objective measure)

    Biceps brachii diameter will be objectively assessed by standardized multi-mode ultrasound at baseline and in 6 weeks in all three study groups (HPD-NMES, LPD-NMES, and Control). The diameter's assessment will be measured on 90o elbow flexion and on 0ο extension.This non-invasive, safe and reproduciple measure requires minimal time and is conducted within scheduled study visits, without altering trial design, primary outcomes, or participant burden.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start6 Jan 2026
  3. Primary completion30 Jun 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07321158
Sponsor's protocol ID
45492/16-05-2025
Acronym
PD-NMES-SPAS
Status last verified
Oct 2026
First submitted
10 Dec 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40688884

  • 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.

    PubMed 36600817

  • 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.

  • 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.

    PubMed 41041108

  • 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.

    PubMed 24382533

  • 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.

    PubMed 36850945

  • 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.

    PubMed 40286626

  • 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.

    PubMed 37877957

  • 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

  • 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.

    PubMed 18948361

  • 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.

    PubMed 15799144

  • 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.

    PubMed 28462794

  • 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.

    PubMed 31574840

  • 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

  • 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.

    PubMed 22737049

Questions about this trial

What is this clinical trial studying?

A study testing High Pulse Duration Neuromuscular Electrical Stimulation Group and Low Pulse Duration Neuromuscular Electrical Stimulation Group in people with Pyramidal Tract-related Spasticity and Upper Motor Neuron Lesion, run by University of West Attica at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in surface electromyography (EMG) parameters (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07321158, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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