Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Safety Measure
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Jocelyne Bloch
Prof.
Centre Hospitalier Universitaire Vaudois
Eligibility 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
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
- •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.
Outcomes
Primary Outcomes
Safety Measure
Time Frame: Through study completion, an average of 1 year
Number of device deficiencies
Secondary Outcomes
- SSEP(8 weeks and 19 weeks after implantation)
- Maximum Voluntary Contraction(1 week before implantation, 8 weeks and 19 weeks after implantation)
- Gait Analysis(1 week before implantation, 8 weeks and 19 weeks after implantation)
- WISCI II score(1 week before implantation, 8 weeks and 19 weeks after implantation)
- 10mWT(1 week before implantation, 8 weeks and 19 weeks after implantation)
- Time Up and Go(1 week before implantation, 8 weeks and 19 weeks after implantation)
- Berg Balance Scale(1 week before implantation, 8 weeks and 19 weeks after implantation)
- Upper Limb Neurobiomechanics(8 weeks and 19 weeks after implantation)
- Weight bearing capacity(1 week before implantation, 8 weeks and 19 weeks after implantation)
- SCIM III score(1 week before implantation, 8 weeks and 19 weeks after implantation)
- 6minWT(1 week before implantation, 8 weeks and 19 weeks after implantation)
- Modified Ashworth Scale(1 week before implantation, 8 weeks and 19 weeks after implantation)
- ASIA score(1 week before implantation, 8 weeks and 19 weeks after implantation)
- WHOQOL-BREF(1 week before implantation, 8 weeks and 19 weeks after implantation)
- BCI performance measures(8 weeks and 19 weeks after implantation)
- ECoG signal stability(8 weeks and 19 weeks after implantation)