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.|
|ClinicalTrials.gov Identifier: NCT05665998|
Recruitment Status : Recruiting
First Posted : December 27, 2022
Last Update Posted : May 24, 2023
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-site, single-arm, non-blinded, non-randomized, interventional|
|Masking:||None (Open Label)|
|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|
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.
- Number of treatment-related serious adverse events (SAEs). [ Time Frame: Through completion of the study 12 months ]
- Graded and Redefined Assessment of Strength Sensibility, and Prehension (GRASSP) score [ Time Frame: 7 months ]0-232 points, higher score indicating better performance
- Action Research Arm Test (ARAT) score [ Time Frame: 7 months ]0-57 points, higher score indicating better performance
- Capabilities of the Upper Extremity Test (CUE-T) [ Time Frame: 7 months ]0-68 points, higher score indicating better performance
- Range of Motion (in rad) [ Time Frame: 7 months ]
- Grasp force (in N) [ Time Frame: 7 months ]
- Pinch force (in N) [ Time Frame: 7 months ]
- International Standards for Neurological Classification of SCI (ISNCSCI) score [ Time Frame: 7 months ]0-324 points, higher score indicating better function
- Maximum voluntary contraction (in N.m) [ Time Frame: 7 months ]
- Somato-sensory evoked potential amplitude (in mV) [ Time Frame: 7 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT05665998
|Contact: Jocelyne Bloch, MD||+41 79 556 29 email@example.com|
|Contact: Henri Lorach, PhD||+41 77 495 50 firstname.lastname@example.org|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Jocelyne Dr Bloch, Prof. Dr.|