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Trial record 4 of 7 for:    Stimo

Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (STIMO-BSI)

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ClinicalTrials.gov Identifier: NCT04632290
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: STIMO-BSI system implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All participants
All participants receive the same intervention.
Device: STIMO-BSI system implantation
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT04632290


Contacts
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Contact: Grégoire Courtine +41 21 693 01 72 stimobsi.contact@epfl.ch

Sponsors and Collaborators
Ecole Polytechnique Fédérale de Lausanne
Investigators
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Principal Investigator: Jocelyne Bloch Centre Hospitalier Universitaire Vaudois
Publications:

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Responsible Party: Jocelyne Bloch, Prof., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04632290    
Other Study ID Numbers: STIMO-BSI
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System