BridgeMD
New treatment option for Spinal Cord Injuries
Official title Transcutaneous Spinal Cord Stimulation for Upper Extremity Function
ClinicalTrials.gov ID: NCT06596369
What this study is testing
- What it's testing
- Transcutaneous electrical stimulation (tcES) of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury (SCI). More recently, the use of invasive, epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke.
- Phase 3: a large, late-stage study
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 75
You may be able to join if
- SCI cohort:
- individuals aged 18 to 75 years of age who have suffered a spinal cord injury
- cervical level injury (C3 to C8)
- at least 1-year post-injury
- for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or...
You likely can't join if
- pregnant women
- aphasia or dysphasia
- spasticity grade Modified Ashworth Scale ≥ 3 Transcranial magnetic stimulation-specific exclusion criteria (both cohorts)
- participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators...
- participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
- participants with a history of seizures or epilepsy
See the full eligibility criteria
- SCI cohort:
- individuals aged 18 to 75 years of age who have suffered a spinal cord injury
- cervical level injury (C3 to C8)
- at least 1-year post-injury
- for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior...
- individuals aged 18-75 years of age who have suffered any type of stroke resulting in upper extremity motor dysfunction with partially preserved motor function
- ≥ 6 months post-stroke
- At least 4 months since last BoNT injection for treatment of spasticity or any other condition or ≤ 2 months after study completion
- for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior...
- pregnant women
- aphasia or dysphasia
- spasticity grade Modified Ashworth Scale ≥ 3 Transcranial magnetic stimulation-specific exclusion criteria (both cohorts)
- participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
- participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
- participants with a history of seizures or epilepsy
- participants taking any medication which may reduce seizure threshold
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. 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.