Upper Motor Neuron DiseaseSDSS_UMSNCT06421753
Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
A study testing SDSS and Standard Electrical Stimulation During Functional Electrical Stimulation in people with Upper Motor Neuron Disease, run by UGECAM Rhône-Alpes at 1 site in France.
Trial summary
To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Motor Neuron Disease
- What is being tested?
- SDSS and Standard Electrical Stimulation During Functional Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2024to 31 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients
Read the detailed description
Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.
Participants will be evaluated before and during the training.
- Conditions
- Upper Motor Neuron Disease
- Being tested
- SDSS, Standard Electrical Stimulation During Functional Electrical Stimulation
- Keywords
- functional electrical stimulation, muscle fatigue, rehabilitation, spinal cord injury, stroke, multiple sclerosis
- Medical subject headings
- Motor Neuron Disease, Spinal Cord Injuries, Stroke, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDSSDevice
Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed.
Standard Electrical Stimulation During Functional Electrical StimulationDevice
Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed.
| Study group | Role | What they receive |
|---|---|---|
| Spatially Distributed Sequential Functional Electrical Stimulation | Experimental | Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling. Receives: Device: SDSS |
| Standard Electrical Stimulation During Functional Electrical Stimulation | Active comparator | Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out. During the second session, the order of the stimulation phases is reversed. Receives: Device: Standard Electrical Stimulation During Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average quadriceps power output (watts) measured during 3 minutes of FES cycling
The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated.
Measured: during sessions of FES cycling
Secondary outcomes (1)
Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes
Dry electrode then hydrogel electrode are placed on the quadriceps' motor point The amplitude of stimulation is increased in steps of 3 mA followed by 5 seconds of rest for subsequent trains until the subject feels a burning sensation. the stimulation threshold (mA) is compared between dry and hydrogel electrode
Measured: before the first session of FES cycling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start16 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- SCED : Single Case Experimental Design Each patient is his own control Patient will be randomised to receive FES-cycling with SDSS or standard electrical stimulation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UGECAM Rhône-Alpes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421753
- Sponsor's protocol ID
- 2024-01-VR
- Acronym
- SDSS_UMS
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jafari E, Kajganic P, Bergeron V, Di Marco J, Metani A, Popovic-Maneski L. Efficacy of high- versus moderate-intensity spatially distributed sequential stimulation in subjects with spinal cord injury: an isometric study. J Neuroeng Rehabil. 2025 Mar 24;22(1):65. doi: 10.1186/s12984-025-01567-2.
PubMed 40122808
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
- ClinicalTrials.gov ID
- NCT06421753
- Acronym / sponsor ID
- SDSS_UMS / 2024-01-VR
- Conditions
- Upper Motor Neuron Disease
- Keywords
- functional electrical stimulation, muscle fatigue, rehabilitation, spinal cord injury, stroke, multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UGECAM Rhône-AlpesUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients
Detailed description
Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.
Participants will be evaluated before and during the training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- SCED : Single Case Experimental Design Each patient is his own control Patient will be randomised to receive FES-cycling with SDSS or standard electrical stimulation
| Arm | Type | Receives |
|---|---|---|
| Spatially Distributed Sequential Functional Electrical Stimulation | Experimental | Device: SDSSInterventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling. |
| Standard Electrical Stimulation During Functional Electrical Stimulation | Active comparator | Device: Standard Electrical Stimulation During Functional Electrical StimulationEach session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out. During the second session, the order of the stimulation phases is reversed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDSSEach session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed. | Device | Spatially Distributed Sequential Functional Electrical Stimulation |
| Standard Electrical Stimulation During Functional Electrical StimulationEach session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed. | Device | Standard Electrical Stimulation During Functional Electrical Stimulation |
Primary outcome
Average quadriceps power output (watts) measured during 3 minutes of FES cycling
Time frame: during sessions of FES cycling
The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated.
1 secondary outcome
Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes
Time frame: before the first session of FES cycling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 40122808Jafari E, Kajganic P, Bergeron V, Di Marco J, Metani A, Popovic-Maneski L. Efficacy of high- versus moderate-intensity spatially distributed sequential stimulation in subjects with spinal cord injury: an isometric study. J Neuroeng Rehabil. 2025 Mar 24;22(1):65. doi: 10.1186/s12984-025-01567-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDSS and Standard Electrical Stimulation During Functional Electrical Stimulation in people with Upper Motor Neuron Disease, run by UGECAM Rhône-Alpes at 1 site in France.
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 8 inclusion and 10 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 19 Sep 2025. 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 France. 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?
Average quadriceps power output (watts) measured during 3 minutes of FES cycling (time frame: during sessions of FES cycling). 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 NCT06421753, which also lists 1 linked publication.
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 19 Sep 2025.