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Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch) (BoxSwitch)

Primary Purpose

Spinal Cord Injuries

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Procedure/Surgery

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring SCI, Spinal Cord Injury, Epidural Spinal Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having completed the main phase of the STIMO study (NCT02936453) and having improved on at least one of the primary or secondary endpoints (WISCI II Score, 10-Meter Walk test, Weight Bearing Capacity, SCIM III Score or 6-Minute Walk test). Age 18-65 SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D SCI ≥ 12months SCI lesion level T10 and above with preservation of conus function SCI due to trauma Stable medical, physical and psychological condition as considered by the investigators Able to understand and interact with the study team in French or English Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments Must provide and sign the Informed Consent prior to any study-related procedures Exclusion Criteria: Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery History of myocardial infarction or cerebrovascular event within the past 6 months Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders) Any active implanted cardiac device such as pacemaker or defibrillator Any indication that would require diathermy Any indication that would require MRI Any anatomical limitations in the implantation area as judged by the investigators Other conditions that would make the subject unable to participate in testing in the judgement of the investigators Clinically significant mental illness in the judgement of the investigators Presence of indwelling baclofen or insulin pump Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant Enrolment of the investigator, his/her family members, employees, and other dependent persons

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted Epidural Spinal Stimulation

Arm Description

Single arm study: the participants that have undergone the STIMO study will be proposed to exchange their currently implanted system with selected components from the ARC-IM Lumbar system. After the surgery, the participants will perform around 20 optimization sessions that may include rehabilitation to configure the neuromodulation system. Then the participants will use the ARC-IM Lumbar system independently during daily life activities until the end of the 36 months post-surgery. Assessments will be planned throughout the course of the study at the end of the optimization phase, after 12 and 24 months post-surgery and at the end of the study, with and/or stimulation.

Outcomes

Primary Outcome Measures

Preliminary safety of the ARC Therapy

Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM system.

Secondary Outcome Measures

10 Meters Walk test (m/s)

The 10 Meters Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.

6 Minutes Walk test (meters)

The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance.

International Standards For Neurological Classification of Spinal Injury (ISNCSCI)

A neurological assessment and classification of a spinal cord injury

Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)

The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI.

Neuromuscular Recovery Scale (NRS)

The NRS is used to measure quality of movement without compensatory movement patterns using a body weight support system and a treadmill.

Walking Index for Spinal Cord Injury (WISCI II)

The Walking Index for Spinal Cord Injury (WISCI) is a scale that measures the type and amount of assistance (in terms of requirements of assistive devices, or human helpers) required by a person with spinal cord injury (SCI) for walking.

Modified Ashworth Scale (MAS)

The modified Ashworth scale a universally accepted clinical tool used to measure the increase of muscle tone.

Spinal Cord Independence Measure (SCIM III)

The SCIM address specific areas of function in patients with spinal cord injuries (SCI).

Quality of Life questionnaires

Questionnaires addressing bowel, bladder and sexual functions.

Full Information

NCT ID

NCT05942339

First Posted

June 12, 2023

Last Updated

July 4, 2023

Sponsor

Ecole Polytechnique Fédérale de Lausanne

1. Study Identification

Unique Protocol Identification Number

NCT05942339

Brief Title

Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch)

Acronym

BoxSwitch

Official Title

Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2023 (Anticipated)

Primary Completion Date

August 2027 (Anticipated)

Study Completion Date

August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ecole Polytechnique Fédérale de Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at supporting mobility in participants with chronic spinal cord injury. Only participants that have undergone the STIMO study (NCT02936453) will be proposed to exchange their currently implanted system with components of the newly developed ARC-IM Lumbar system. The goal is to improve more effective lower-limb motor activities, while also simplifying the personal at-home use of the system. In addition, this study aims to evaluate the potential effect of ARC Therapy on muscle tone, bladder, bowel and sexual functions, and quality of life of the participants. Preliminary safety and efficacy will be assessed in both the short term and throughout the duration of the study (from the surgery to 36 months after the implantation of the ARC-IM Lumbar system).

Detailed Description

Studies have shown that using Electrical Epidural Stimulation (EES) could improve considerably the functional movements after paralyzing SCI. In the STIMO study (NCT02936453), the investigational system was mainly composed of medical devices developed for other indications and used off-label, allowing only a limited tuning of EES protocols. To overcome this limitation, we propose to conduct a study in which a new platform will be investigated. This new therapy, named ARC Therapy, features the ARC-IM implantable pulse generator with an optimized communication system and the ARC-IM implantable leads supporting stimulation protocols specifically developed for effective activation of motor neurons. The study will take place at the CHUV (Lausanne, Switzerland). A maximum of 8 participants will be enrolled in the study and implanted with an ARC-IM IPG. Only participants that have undergone the STIMO protocol (NCT02936453) can enrol in the current BoxSwitch study. Replacement of their currently implanted IPG and lead will be assessed on a case-by-case manner considering current status of their implanted devices, technical and surgical compatibility with the newly proposed ARC-IM Lumbar system components. The study intervention consists of several phases preceded by pre-screening: Screening and enrollment, baseline and pre-implantation assessments, surgery, optimization phase, short-term assessments, independent use phase and follow-up assessments at months 12, 24 and 36. Measures will be performed before surgical intervention and at regular intervals during the study. The total duration of the study will be approximately 48 months (up to 36 months/participant).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

SCI, Spinal Cord Injury, Epidural Spinal Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-site, single-arm, non-blinded, non-randomized, interventional

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Targeted Epidural Spinal Stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Procedure/Surgery

Intervention Description

The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.

Primary Outcome Measure Information:

Title

Preliminary safety of the ARC Therapy

Description

Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM system.

Time Frame

Through study completion (expected 3 years)

Secondary Outcome Measure Information:

Title

10 Meters Walk test (m/s)

Description

The 10 Meters Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

6 Minutes Walk test (meters)

Description

The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance.

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

International Standards For Neurological Classification of Spinal Injury (ISNCSCI)

Description

A neurological assessment and classification of a spinal cord injury

Time Frame

Baseline, 12 months, 24 months and 36 months

Title

Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)

Description

The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI.

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

Neuromuscular Recovery Scale (NRS)

Description

The NRS is used to measure quality of movement without compensatory movement patterns using a body weight support system and a treadmill.

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

Walking Index for Spinal Cord Injury (WISCI II)

Description

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

Modified Ashworth Scale (MAS)

Description

The modified Ashworth scale a universally accepted clinical tool used to measure the increase of muscle tone.

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

Spinal Cord Independence Measure (SCIM III)

Description

The SCIM address specific areas of function in patients with spinal cord injuries (SCI).

Time Frame

Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Title

Quality of Life questionnaires

Description

Questionnaires addressing bowel, bladder and sexual functions.

Time Frame

Monthly during the first year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Grégoire Courtine, Prof

Phone

+41 21 69 30762

gregoire.courtine@epfl.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jocelyne Bloch, MD

Organizational Affiliation

CHUV

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch)

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