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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEcole Polytechnique Fédérale de Lausanne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • ARC-BSI Cervical system

    Device

    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.

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: ARC-BSI Cervical RehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through completion of the study 12 months

Secondary outcomes

1

Graded and Redefined Assessment of Strength Sensibility, and Prehension (GRASSP) score

0-232 points, higher score indicating better performance

Time frame
7 months
2

Action Research Arm Test (ARAT) score

0-57 points, higher score indicating better performance

Time frame
7 months
3

Capabilities of the Upper Extremity Test (CUE-T)

0-68 points, higher score indicating better performance

Time frame
7 months
4

Range of Motion (in rad)

Time frame
7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.