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)

July 4, 2023 updated by: Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Age 18-65
  3. SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D
  4. SCI ≥ 12months
  5. SCI lesion level T10 and above with preservation of conus function
  6. SCI due to trauma
  7. Stable medical, physical and psychological condition as considered by the investigators
  8. Able to understand and interact with the study team in French or English
  9. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
  10. Must provide and sign the Informed Consent prior to any study-related procedures

Exclusion Criteria:

  1. Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
  2. History of myocardial infarction or cerebrovascular event within the past 6 months
  3. Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
  4. Any active implanted cardiac device such as pacemaker or defibrillator
  5. Any indication that would require diathermy
  6. Any indication that would require MRI
  7. Any anatomical limitations in the implantation area as judged by the investigators
  8. Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
  9. Clinically significant mental illness in the judgement of the investigators
  10. Presence of indwelling baclofen or insulin pump
  11. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  12. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant
  13. Enrolment of the investigator, his/her family members, employees, and other dependent persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Targeted Epidural Spinal Stimulation

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.
Device: Procedure/Surgery
The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary safety of the ARC Therapy
Time Frame: Through study completion (expected 3 years)
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.
Through study completion (expected 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 Meters Walk test (m/s)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
The 10 Meters Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
6 Minutes Walk test (meters)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance.
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
Time Frame: Baseline, 12 months, 24 months and 36 months
A neurological assessment and classification of a spinal cord injury
Baseline, 12 months, 24 months and 36 months
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI.
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Neuromuscular Recovery Scale (NRS)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
The NRS is used to measure quality of movement without compensatory movement patterns using a body weight support system and a treadmill.
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Walking Index for Spinal Cord Injury (WISCI II)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
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.
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Modified Ashworth Scale (MAS)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
The modified Ashworth scale a universally accepted clinical tool used to measure the increase of muscle tone.
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Spinal Cord Independence Measure (SCIM III)
Time Frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
The SCIM address specific areas of function in patients with spinal cord injuries (SCI).
Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Quality of Life questionnaires
Time Frame: Monthly during the first year
Questionnaires addressing bowel, bladder and sexual functions.
Monthly during the first year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ecole Polytechnique Fédérale de Lausanne

Investigators

  • Principal Investigator: Jocelyne Bloch, MD, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOX2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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