This is the classic website, which will be retired eventually. Please visit the modernized instead.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05665998
Recruitment Status : Recruiting
First Posted : December 27, 2022
Last Update Posted : May 24, 2023
Information provided by (Responsible Party):
Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne

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.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Tetraplegia Device: ARC-BSI Cervical system Not Applicable

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 (, 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) ( 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-site, single-arm, non-blinded, non-randomized, interventional
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation (UP2)
Actual Study Start Date : May 22, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ARC-BSI Cervical Rehabilitation
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.
Device: ARC-BSI Cervical system
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 Measures :
  1. Number of treatment-related serious adverse events (SAEs). [ Time Frame: Through completion of the study 12 months ]

Secondary Outcome Measures :
  1. Graded and Redefined Assessment of Strength Sensibility, and Prehension (GRASSP) score [ Time Frame: 7 months ]
    0-232 points, higher score indicating better performance

  2. Action Research Arm Test (ARAT) score [ Time Frame: 7 months ]
    0-57 points, higher score indicating better performance

  3. Capabilities of the Upper Extremity Test (CUE-T) [ Time Frame: 7 months ]
    0-68 points, higher score indicating better performance

  4. Range of Motion (in rad) [ Time Frame: 7 months ]
  5. Grasp force (in N) [ Time Frame: 7 months ]
  6. Pinch force (in N) [ Time Frame: 7 months ]
  7. International Standards for Neurological Classification of SCI (ISNCSCI) score [ Time Frame: 7 months ]
    0-324 points, higher score indicating better function

  8. Maximum voluntary contraction (in N.m) [ Time Frame: 7 months ]
  9. Somato-sensory evoked potential amplitude (in mV) [ Time Frame: 7 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05665998

Layout table for location contacts
Contact: Jocelyne Bloch, MD +41 79 556 29 51
Contact: Henri Lorach, PhD +41 77 495 50 48

Layout table for location information
CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Jocelyne Dr Bloch, Prof. Dr.         
Sponsors and Collaborators
Ecole Polytechnique Fédérale de Lausanne
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.

Layout table for additonal information
Responsible Party: Jocelyne Bloch, Certified neurosurgeon, head of functional neurosurgery, Ecole Polytechnique Fédérale de Lausanne Identifier: NCT05665998    
Other Study ID Numbers: UP2
First Posted: December 27, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne:
Spinal cord stimulation
Brain computer interface
Brain spine interface
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations