Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05665998

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

Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2026-04-23

3

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new system that uses brain signals to control electrical stimulation of the spinal cord in people with cervical spinal cord injury. This approach aims to restore voluntary arm movements by connecting motor intentions from the brain to spinal cord stimulation below the injury. The study focuses on safety and early effectiveness in three participants with chronic, severe spinal cord injuries who have significant upper limb impairment. The investigational treatment involves implanting a neuroprosthetic device combining a 64-channel electrocorticography (ECoG) array over the motor cortex and a 32-channel cervical epidural electrical spinal cord stimulation system. This system decodes the participant's motor intentions and translates them into muscle-specific electrical stimulation to promote arm movement. The implanted device allows continuous brain signal recording and spinal cord stimulation designed to restore voluntary control and support neurorehabilitation. Participants will undergo assessments of safety through monitoring serious adverse events during the 12-month study. Functional outcomes related to upper limb strength, sensation, motion range, and motor control will be measured using several standardized tests over 7 months. The study includes monitoring neurological status, muscle force, and sensory evoked potentials. Participants are expected to engage in follow-up visits and comply with study protocols to help evaluate the system's impact on arm function and overall neurological recovery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must provide informed consent documented by signature
  • Must be aged between 18 and 75 years at enrollment
  • Must have a non-progressive traumatic cervical spinal cord injury
  • Must be classified as A, B, C, or D on the ASIA Impairment Scale
  • Must have completed primary standard rehabilitation care
  • Must have severe upper limb impairment as determined by the investigator
  • Must have sustained the injury at least 6 months before consent
  • Must be able to understand and communicate in French or English
  • Must agree to comply with study conditions and attend all appointments
  • Women of childbearing potential must use safe contraception
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of severe autonomic dysreflexia
  • Brain damage or history of epilepsy
  • Spinal stenosis or post-traumatic damage at implantation site
  • Gastrointestinal ulcers within the last five years
  • Psychological disorders
  • Intention to become pregnant during the study
  • Known or suspected drug or alcohol abuse
  • Participation in another clinical study with drugs or devices within 30 days prior or during this study
  • Previous stem cell injection in the spinal cord
  • Investigator or related persons
  • Unstable or significant medical conditions interfering with study
  • Hematological disorders increasing surgical risk
  • Need for ventilator support
  • Spinal cord injury from non-traumatic causes
  • Spasms limiting participation in study training
  • Use of intrathecal baclofen pump
  • Implanted pacemakers or defibrillators
  • Need for MRI
  • Congenital or acquired upper limb abnormalities affecting joints or bones

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Not specified

Participants undergo unilateral implantation of a neuroprosthetics system composed of an electrocorticography acquisition system and a cervical epidural electrical spinal cord stimulation system to restore voluntary arm movements.

Treatment

Duration - Up to 7 months

Participants use the implanted ARC-BSI Cervical system, which decodes motor attempts and modulates electrical stimulation to enable voluntary control of arm movements combined with neurorehabilitation.

Regular visits during the treatment period

Trial Site Locations

Total: 1 location

1

CHUV

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

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Research Team

J

Jocelyne Bloch, MD

H

Henri Lorach, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis.

Andreas Rowald, Salif Komi, Robin Demesmaeker...

https://pubmed.ncbi.nlm.nih.gov/35132264

An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration.

Alim Louis Benabid, Thomas Costecalde, Andrey Eliseyev...

https://pubmed.ncbi.nlm.nih.gov/31587955