High versus low pulse‑duration electrical stimulation for upper‑limb spasticity after pyramidal tract injury
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
This trial will try high versus low pulse‑duration neuromuscular electrical stimulation to reduce upper‑limb spasticity in people with pyramidal tract–related upper motor neuron lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of West Attica Academic / other |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT07321158 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 45 patients with pyramidal tract–related upper limb spasticity and randomize them 1:1:1 to high‑pulse‑duration NMES, low‑pulse‑duration NMES, or usual care. All participants receive conventional physiotherapy three times weekly for six weeks while NMES groups receive 30‑minute stimulation sessions with differing pulse durations. Outcomes include clinical spasticity scales (Modified Ashworth Scale, Modified Tardieu Scale, Composite Spasticity Scale) and neurophysiological measures (H‑reflex, M‑wave, Hmax/Mmax ratio) measured before and after the intervention. The goal is to determine whether pulse duration changes NMES effectiveness and to help standardize NMES parameters for upper limb spasticity.
Who should consider this trial
Good fit: Adults with a first-time pyramidal tract lesion causing upper‑limb spasticity, intact cognition, normal vital signs, and without excluded comorbidities (for example uncontrolled cardiovascular disease, active seizures, severe obesity, relevant skin or musculoskeletal problems, metallic residues in the limb, or pregnancy) are ideal candidates.
Not a fit: Patients with prior pyramidal tract damage, cognitive decline, significant comorbidities, skin lesions or metallic implants in the affected limb, BMI over 30, active seizures, or pregnancy are excluded and therefore unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could reduce arm spasticity and improve function and quality of life for people with pyramidal tract lesions.
How similar studies have performed: Previous studies have shown NMES can reduce spasticity, but protocols and parameters vary widely and direct comparisons of different pulse durations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Athens, Attica
- Attikon Hospital — Athens, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Athanasios K. Chasiotis, Physiotherapist
- Email: thanosch1@gmail.com , achasiotis@uniwa.gr
- Phone: +306973257982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.