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New treatment option for Stroke
Official title Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation
ClinicalTrials.gov ID: NCT07610850
What this study is testing
- What it's testing
- The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with cervical and lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of upper and lower limbs in participants with chronic stroke suffering from mobility impairment. The goal is to establish a direct bridge between the motor intention of the participant and the spinal cord, which should not only improve or restore voluntary control of arm and leg movement and support immediate mobility, but also promote neurological recovery when combined with neurorehabilitation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Must be between 18-70 years old at the time of enrolment.
- Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment.
- Must have a score lower than 25 on the Fugl-Meyer upper-limb scale.
- Must be able to stand with or without assistive device for 30 seconds.
- Must have a score higher than 22 at the Montreal Cognitive Assessment.
You likely can't join if
- Must not be pregnant or breast feeding (if applicable).
- Must not have the intention to become pregnant during the study (if applicable).
- Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery.
- Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by...
- Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g...
- Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support.
See the full eligibility criteria
- Must be between 18-70 years old at the time of enrolment.
- Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment.
- Must have a score lower than 25 on the Fugl-Meyer upper-limb scale.
- Must be able to stand with or without assistive device for 30 seconds.
- Must have a score higher than 22 at the Montreal Cognitive Assessment.
- Must present right or left hemiplegia.
- Must have completed primary standard of care rehabilitation.
- Must provide and sign the study's Informed Consent prior to any study-related procedures.
- Must be able to understand and interact with the study team in French or English.
- Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.
- Must use effective contraception for women of childbearing capacity.
- Must be able to withhold antiplatelet/anticoagulation agents perioperatively for the time of the surgeries (if applicable).
- Must not be pregnant or breast feeding (if applicable).
- Must not have the intention to become pregnant during the study (if applicable).
- Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery.
- Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by the psychologist.
- Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., major cognitive disorder, renal failure, hepatic dysfunction, epilepsy...
- Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support.
- Must not have any active implanted device, such as a pacemaker or other neurostimulator.
- Must not have any spinal anatomical abnormalities or incompatibilities with the implanted system precluding surgery.
- Must not have severe spasticity of the upper limb or lower limb (Modified Ashworth Scale \> 3).
- Must not have indication requiring frequent MRIs.
- Must not participate in another clinical study using drugs or medical devices that might interfere with the outcomes of the study.
- Must not be the investigator him/herself, his/her family members, employees, and other dependent persons.
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.