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Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation (UP2)

Primary Purpose

Cervical Spinal Cord Injury, Tetraplegia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ARC-BSI Cervical system
Sponsored by
Ecole Polytechnique Fédérale de Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury focused on measuring Spinal cord stimulation, Brain computer interface, Brain spine interface

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Must provide Informed Consent as documented by signature (Appendix Informed Consent Form), Must be at least 18 years old and no older than 75 years old at the time of enrolment, Must be suffering from non-progressive traumatic cervical spinal cord injury, Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification, Must have completed primary standard of care rehabilitation, Must be severely impaired in his upper limb function as determined by the investigator, Must have sustained the injury at least 6 months before signing the consent form, Must be able to understand and interact with the study team in French or English, Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments, Must use safe contraception for women of childbearing capacity, Must not be pregnant nor breast feeding, Must not have history of severe autonomic dysreflexia, Must not have brain damage, Must not have history of epilepsy, Must not have spinal stenosis, Must not have gastrointestinal ulcers in the last five years, Must not have any psychological disorder, Must not have the intention to become pregnant during the course of the study, Must not be known or suspected of drug or alcohol abuse, Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study, Must not have previously been injected with stem cells in the spinal cord, Must not be the investigator himself, his/her family members, employees or other dependent persons, Must not have any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator, Must not have any hematological disorders with increased risk for surgical intervention, Must not require ventilator support, Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc), Must not be subject to spasms that limit the ability of the subject to participate in the study training as determined by the investigator, Must not display spinal stenosis or post traumatic damage at location of implantation, Must not require the use of an intrathecal baclofen pump, Must not be implanted with a device such as pacemakers or defibrillators, Must not have any indication that would require an MRI, Must not suffer from congenital nor acquired upper limb abnormalities (affection of joints or bones).

Sites / Locations

  • CHUVRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARC-BSI Cervical Rehabilitation

Arm Description

Implantation of a neuroprosthetics system composed of an electrocorticography acquisition system (WIMAGINE) and a cervical epidural electrical spinal cord stimulation system (ARC-IM) to restore voluntary arm movements in participants with SCI.

Outcomes

Primary Outcome Measures

Number of treatment-related serious adverse events (SAEs).

Secondary Outcome Measures

Graded and Redefined Assessment of Strength Sensibility, and Prehension (GRASSP) score
0-232 points, higher score indicating better performance
Action Research Arm Test (ARAT) score
0-57 points, higher score indicating better performance
Capabilities of the Upper Extremity Test (CUE-T)
0-68 points, higher score indicating better performance
Range of Motion (in rad)
Grasp force (in N)
Pinch force (in N)
International Standards for Neurological Classification of SCI (ISNCSCI) score
0-324 points, higher score indicating better function
Maximum voluntary contraction (in N.m)
Somato-sensory evoked potential amplitude (in mV)

Full Information

First Posted
December 14, 2022
Last Updated
May 22, 2023
Sponsor
Ecole Polytechnique Fédérale de Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT05665998
Brief Title
Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation
Acronym
UP2
Official Title
Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation (UP2)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
July 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cervical spinal cord stimulation can elicit arm and hand movements through recruitment of proprioceptive neurons in the dorsal roots. In participants with cervical spinal cord injury, the spare roots bellow the lesion can be used to reactivate motor function. Decoding of motor intentions can be achieved through implantable electrocorticography (ECoG) devices. In this study, the investigators will use an investigational system using ECoG signal recording over the motor cortex to drive muscle specific electrical epidural spinal cord stimulation (EES). The investigators will assess the safety and preliminary efficacy of this system in 3 participants.
Detailed Description
In a current first-in-human clinical trial, called STIMO, Electrical Epidural Spinal Stimulation (EES) is applied to enable individuals with chronic severe spinal cord injury (SCI) to complete intensive locomotor neurorehabilitation training. In this clinical feasibility study, EES triggered an immediate enhancement of walking function, and was integrated in an intensive neurorehabilitation program. This therapy improved leg motor control and triggered neurological recovery in individuals with severe SCI to a certain extent (Wagner et al. 2018, Kathe et al. 2022). Concurrently, preclinical and clinical evidence demonstrated a similar recruitment of upper limb muscles through cervical spinal cord stimulation, re-triggering arm movements after paralysis. The spatial and temporal modulation of the electrical stimulation can selectively activate muscle groups towards a specific function. Clinatec (CEA, Grenoble, France) has developed an implantable electrocorticogram (ECoG) recording device with a 64-channel epidural electrode array capable of recording electrical signals from the motor cortex for an extended period and with a high signal to noise ratio. This ECoG-based system allowed tetraplegic patients to control an exoskeleton (Clinicaltrials.gov, NCT 02550522) with up to 8 degrees of freedom for the upper limb control (Benabid et al., 2019). This device has been implanted in 4 individuals so far; one of them has been using this system both at the hospital and at home for more than 3 years. Another ongoing clinical study: STIMO-BSI (Brain Spine Interface) (Clinicaltrials.gov: NTC04632290), is combining the EES and ECoG technology to allow leg motor control in patients with chronic SCI through the decoding of cortical signals. In this study, the investigators will test the safety and preliminary efficacy of ECoG-controlled EES in individuals with cervical SCI and establish a direct bridge between the participants' motor intention and the spinal cord below the lesion, which could restore voluntary control of arm movements as well as promote neurological recovery when combined with neurorehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury, Tetraplegia
Keywords
Spinal cord stimulation, Brain computer interface, Brain spine interface

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
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARC-BSI Cervical Rehabilitation
Arm Type
Experimental
Arm Description
Implantation of a neuroprosthetics system composed of an electrocorticography acquisition system (WIMAGINE) and a cervical epidural electrical spinal cord stimulation system (ARC-IM) to restore voluntary arm movements in participants with SCI.
Intervention Type
Device
Intervention Name(s)
ARC-BSI Cervical system
Intervention Description
Unilateral implantation of a 64 channel - ECoG array over the sensory motor cortex combined with an implantation of 32 channel spinal cord stimulation system over the cervical region. The system decodes the motor attempts of the participant and translates those intentions into modulation of electrical stimulation.
Primary Outcome Measure Information:
Title
Number of treatment-related serious adverse events (SAEs).
Time Frame
Through completion of the study 12 months
Secondary Outcome Measure Information:
Title
Graded and Redefined Assessment of Strength Sensibility, and Prehension (GRASSP) score
Description
0-232 points, higher score indicating better performance
Time Frame
7 months
Title
Action Research Arm Test (ARAT) score
Description
0-57 points, higher score indicating better performance
Time Frame
7 months
Title
Capabilities of the Upper Extremity Test (CUE-T)
Description
0-68 points, higher score indicating better performance
Time Frame
7 months
Title
Range of Motion (in rad)
Time Frame
7 months
Title
Grasp force (in N)
Time Frame
7 months
Title
Pinch force (in N)
Time Frame
7 months
Title
International Standards for Neurological Classification of SCI (ISNCSCI) score
Description
0-324 points, higher score indicating better function
Time Frame
7 months
Title
Maximum voluntary contraction (in N.m)
Time Frame
7 months
Title
Somato-sensory evoked potential amplitude (in mV)
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Must provide Informed Consent as documented by signature (Appendix Informed Consent Form), Must be at least 18 years old and no older than 75 years old at the time of enrolment, Must be suffering from non-progressive traumatic cervical spinal cord injury, Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification, Must have completed primary standard of care rehabilitation, Must be severely impaired in his upper limb function as determined by the investigator, Must have sustained the injury at least 6 months before signing the consent form, Must be able to understand and interact with the study team in French or English, Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments, Must use safe contraception for women of childbearing capacity, Must not be pregnant nor breast feeding, Must not have history of severe autonomic dysreflexia, Must not have brain damage, Must not have history of epilepsy, Must not have spinal stenosis, Must not have gastrointestinal ulcers in the last five years, Must not have any psychological disorder, Must not have the intention to become pregnant during the course of the study, Must not be known or suspected of drug or alcohol abuse, Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study, Must not have previously been injected with stem cells in the spinal cord, Must not be the investigator himself, his/her family members, employees or other dependent persons, Must not have any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator, Must not have any hematological disorders with increased risk for surgical intervention, Must not require ventilator support, Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc), Must not be subject to spasms that limit the ability of the subject to participate in the study training as determined by the investigator, Must not display spinal stenosis or post traumatic damage at location of implantation, Must not require the use of an intrathecal baclofen pump, Must not be implanted with a device such as pacemakers or defibrillators, Must not have any indication that would require an MRI, Must not suffer from congenital nor acquired upper limb abnormalities (affection of joints or bones).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne Bloch, MD
Phone
+41 79 556 29 51
Email
jocelyne.bloch@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Henri Lorach, PhD
Phone
+41 77 495 50 48
Email
henri.lorach@epfl.ch
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyne Dr Bloch, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30382197
Citation
Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
Results Reference
background
PubMed Identifier
36352232
Citation
Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9.
Results Reference
background
PubMed Identifier
35132264
Citation
Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.
Results Reference
background
PubMed Identifier
34425566
Citation
Larzabal C, Bonnet S, Costecalde T, Auboiroux V, Charvet G, Chabardes S, Aksenova T, Sauter-Starace F. Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients. J Neural Eng. 2021 Sep 9;18(5). doi: 10.1088/1741-2552/ac2003.
Results Reference
background
PubMed Identifier
31587955
Citation
Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.
Results Reference
background
PubMed Identifier
36196116
Citation
Lorach H, Charvet G, Bloch J, Courtine G. Brain-spine interfaces to reverse paralysis. Natl Sci Rev. 2022 Jan 18;9(10):nwac009. doi: 10.1093/nsr/nwac009. eCollection 2022 Oct. No abstract available.
Results Reference
background

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Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation

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