## Protocol Section
### Identification Module
**NCT ID:** NCT06421753

**Acronym:** SDSS_UMS

**Brief Title:** Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients

**Official Title:** Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients

#### Organization Study ID Info
**ID:** 2024-01-VR
#### Organization
**Class:** OTHER
**Full Name:** UGECAM Rhône-Alpes
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** UGECAM Rhône-Alpes

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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

**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 Module

**Conditions:**

- Upper Motor Neuron Disease

**Keywords:**

- functional electrical stimulation

- muscle fatigue

- rehabilitation

- spinal cord injury

- stroke

- multiple sclerosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention 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 Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: SDSS

**Label:** Spatially Distributed Sequential Functional Electrical Stimulation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: Standard Electrical Stimulation During Functional Electrical Stimulation

**Label:** Standard Electrical Stimulation During Functional Electrical Stimulation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Spatially Distributed Sequential Functional Electrical Stimulation

**Description:** 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.

**Name:** SDSS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Standard Electrical Stimulation During Functional Electrical Stimulation

**Description:** 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.

**Name:** Standard Electrical Stimulation During Functional Electrical Stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Average quadriceps power output (watts) measured during 3 minutes of FES cycling

**Time Frame:** during sessions of FES cycling

#### Secondary Outcomes

**Description:** 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

**Measure:** Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes

**Time Frame:** before the first session of FES cycling

### Eligibility Module

**Eligibility 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr.jdimarco@gmail.com

**Name:** julie di marco, MD

**Phone:** 01133472532161

**Role:** CONTACT

**Contact 2:**

**Email:** secmedhdj.valrosay@ugecam.assurance-maladie.fr

**Name:** sarah finel

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Saint didier au mont d'or

**Contacts:**

***Contact 1:***

- **Email:** dr.jdimarco@gmail.com

- **Name:** julie di marco, MD

- **Phone:** 01133472532161

- **Role:** CONTACT

***Contact 2:***

- **Name:** julie di marco, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** SMR Val Rosay

**Status:** RECRUITING

**Zip:** 69370

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000057177

- Term: TDP-43 Proteinopathies

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M15415

- Name: Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M18879

- Name: Motor Neuron Disease

- Relevance: HIGH

- As Found: Motor Neuron Disease

- ID: M4024

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Motor Neuron Disease

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M28759

- Name: TDP-43 Proteinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T349

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Motor Neuron Disease

- ID: T4699

- Name: Primary Lateral Sclerosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016472

- Term: Motor Neuron Disease

- ID: D000000690

- Term: Amyotrophic Lateral Sclerosis

### Misc Info Module

- Version Holder: 2024-05-31
