Using advanced electrical stimulation to improve movement in patients with upper motor neuron syndrome
Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
This study is testing if a new type of electrical stimulation can help improve movement in people with upper motor neuron syndrome better than the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | UGECAM Rhône-Alpes Academic / other |
| Locations | 1 site (Saint didier au mont d'or) |
| Trial ID | NCT06421753 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Spatially Distributed Sequential Functional Electrical Stimulation (SDSS) against Standard Electrical Stimulation (SES) in patients suffering from upper motor neuron syndrome. It employs a single case experimental design, where participants will undergo three cycling sessions of functional electrical stimulation, with evaluations conducted before and during the training. The sessions will include a warm-up phase followed by electrically stimulated cycling, with rest periods in between. The goal is to assess whether the new stimulation method leads to better rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with motor deficits due to upper motor neuron syndrome who can tolerate electrical stimulation.
Not a fit: Patients with major cognitive disorders, cardiac pacemakers, or severe spasticity of the lower limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for patients with upper motor neuron syndrome.
How similar studies have performed: While there have been studies on electrical stimulation for rehabilitation, the specific approach of SDSS is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with Upper Motor Neuron syndrome: * adult (\> 18 years) * motor deficit due to an acquired traumatic or neurodegenerative motor deficiency of the central nervous system (MRC\<4/5) * stable clinical condition, particularly on the cardiovascular level (recent assessment by a cardiologist with stress test) * non denervated muscles * tolerant to muscle electrical stimulation * having given written consent * able to cycle 30 minutes with FES-cycling Exclusion Criteria: * major cognitive comprehension disorders that could compromise understanding of the protocol and the smooth running of the study * cardiac pacemaker and other contraindications relating to the use of electrostimulation (in particularly "deep vein thrombosis") * spasticity of the lower limbs making flexion/extension movement difficult * participation in another study * pregnancy * people with the following legal and administrative states or situations: * people placed under judicial protection; * persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation; * unemancipated minors; * people who are not affiliated to a social security scheme or beneficiaries of such a scheme
Where this trial is running
Saint didier au mont d'or
- SMR Val Rosay — Saint didier au mont d'or, France (Recruiting)
Study contacts
- Study coordinator: julie di marco, MD
- Email: dr.jdimarco@gmail.com
- Phone: 01133472532161
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.