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Active, Not Recruiting

NCT Number: NCT04632290

Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury

In a current first-in-human study, called Stimulation Movement Overground (STIMO, NCT02936453), Epidural Electrical Stimulation (EES) of the spinal cord is applied to enable individuals with chronic severe spinal cord injury (SCI) to complete intensive locomotor neurorehabilitation training. In this clinical feasibility study, it was demonstrated that EES results in an immediate enhancement of walking function, and that when applied repeatedly as part of a neurorehabilitation program, EES can improve leg motor control and trigger neurological recovery in individuals with severe SCI to a certain extent (Wagner et al. 2018).

Preclinical studies showed that linking brain activity to the onset and modulation of spinal cord stimulation protocols not only improves the usability of the stimulation, but also augments neurological recovery. Indeed, rats rapidly learned to modulate their cortical activity in order to adjust the amplitude of spinal cord stimulation protocols. This brain-spine interface allowed them to increase the amplitude of the movement of their otherwise paralyzed legs to climb up a staircase (Bonizzato et al. 2018). Moreover, gait rehabilitation enabled by this brain-spine interface (BSI) augmented plasticity and neurological recovery. When EES was correlated with cortical neuron activity during training, rats showed better recovery than when training was only supported by continuous stimulation (Bonizzato et al. 2018). This concept of brain spine-interface was validated in non-human primates (Capogrosso et al. 2016).

Clinatec (Grenoble, France) has developed a fully 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 of time and with a high signal to noise ratio the electrical signals from the motor cortex. This ECoG-based system allowed tetraplegic patients to control an exoskeleton (ClinicalTrials.gov, NCT02550522) with up to 8 degrees of freedom for the upper limb control (Benabid et al. 2019). This device was implanted in 2 individuals so far; one of them has been using this system both at the hospital and at home for more than 3 years.

We hypothesize that ECoG-controlled EES in individuals with SCI will establish a direct bridge between the patient's motor intention and the spinal cord below the lesion, which will not only improve or restore voluntary control of leg movements, but will also boost neuroplasticity and neurological recovery when combined with neurorehabilitation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having completed the main phase of the STIMO study (NCT02936453).
  • SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D
  • Level of lesion: T10 and above, based on AIS level determination by the PI, with preservation of conus function
  • The intact distance between the cone and the lesion must be at least 60 mm.
  • Focal spinal cord disorder caused by either trauma or epidural, subdural or intramedullary bleeding
  • Minimum 12 months post-injury
  • Completed in-patient rehabilitation program
  • Stable medical, physical and psychological condition as considered by Investigators
  • Able to understand and interact with the study team in French or English
  • Adequate care-giver support and access to appropriate medical care in patient's home community
  • Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
  • Must provide and sign the Informed Consent prior to any study related procedures

Exclusion criteria

  • Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
  • History of severe autonomic dysreflexia
  • Brain damage
  • Epilepsy
  • Spinal stenosis
  • Use of an intrathecal Baclofen pump.
  • Any active implanted cardiac device such as pacemaker or defibrillator.
  • Any indication that would require diathermy.
  • Any indication that would require MRI.
  • Increased risk for defibrillation.
  • Severe joint contractures disabling or restricting lower limb movements.
  • Haematological disorders with increased risk for surgical interventions (increased risk of haemorrhagic events).
  • Congenital or acquired lower limb abnormalities (affection of joints and bone).
  • Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breast feeding or not willing to take contraception.
  • Known or suspected non-compliance, drug or alcohol abuse.
  • Spinal cord lesion due to either a neurodegenerative disease or a tumor.
  • Gastrointestinal ulcers in the last five years
  • Known or suspected eye disorders or diseases
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  • Any other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results

Treatment and study plan

STIMO-BSI system implantation

Device

Participants are implanted bilaterally with epidural electrocorticography devices. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.

ARC-BSI Lumbar System

Device

ARC-BSI Lumbar System for participants entering the optional extension with system upgrade: replacement of the neurostimulator, and upgrade of the WIMAGINE system and STIMO system wearable devices.

Primary outcomes

  1. Safety Measure

    Time frame: Through study completion, an average of 1 year

    Number of Adverse Events possibly, probably or causally related to the procedure or device.

  2. Safety Measure

    Time frame: Through study completion, an average of 1 year

    Number of device deficiencies

Secondary outcomes

  1. WISCI II score

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    From 0 to 20, higher scores mean a better outcome

  2. 10mWT

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

  3. Weight bearing capacity

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

  4. SCIM III score

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    From 0 to 100, higher scores mean a better outcome

  5. 6minWT

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

  6. Time Up and Go

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

  7. Maximum Voluntary Contraction

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

  8. ASIA score

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    From 0 to 100, higher scores mean a better outcome

  9. Modified Ashworth Scale

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    From 0 to 4, higher scores mean a worst outcome

  10. Berg Balance Scale

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    From 0 to 56, higher scores mean a better outcome

  11. Gait Analysis

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    Average step height, step length, amplitude of EMG activity during walking

  12. WHOQOL-BREF

    Time frame: 1 week before implantation, 8 weeks and 19 weeks after implantation

    From 0 to 100, higher scores mean a better outcome

  13. BCI performance measures

    Time frame: 8 weeks and 19 weeks after implantation

    Decoding accuracy from 0-100% higher numbers mean a better outome

  14. Upper Limb Neurobiomechanics

    Time frame: 8 weeks and 19 weeks after implantation

    Average range of movement, amplitude of EMG activity during upper limb movements

  15. ECoG signal stability

    Time frame: 8 weeks and 19 weeks after implantation

    Power density spectrum of the ECoG signal over each electrode

  16. SSEP

    Time frame: 8 weeks and 19 weeks after implantation

    Amplitude and latency of the cortically evoked potentials

Sponsors and collaborators

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Other

Registry information

Acronym: STIMO-BSI

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 17, 2020
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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