BridgeMD
New treatment option for Spinal Cord Injury
Official title Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury
ClinicalTrials.gov ID: NCT06867809
What this study is testing
- What it's testing
- Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury. While some scientists have begun to study the effect of electrical stimulation on patient's ability to walk and move their legs after lower spinal cord injury, the use of stimulation of the upper (cervical) spine to restore arm and hand function after cervical spinal cord injury remains less well explored.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥18 years with incomplete traumatic SCI (American Spinal Injury Association (ASIA) B-D, levels between C4 to T1) incurred \> 1 year...
- At least 2/5 motor power in at least one upper extremity muscle group
- International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score (ISNCSCI-UEMS) ≤ 40/50
- Able to follow multistep commands
- Ability and willingness to provide informed consent
You likely can't join if
- Cervical or thoracic stenosis that would preclude safe lead placement
- Any ongoing ventilator use (continuous or intermittent)
- Urinary tract infection or pneumonia requiring treatment (within past 3 months)
- Skin ulcers or other lesions
- History of posterior cervical fusion
- Autonomic dysreflexia requiring treatment (within past 3 months)
See the full eligibility criteria
- Patients aged ≥18 years with incomplete traumatic SCI (American Spinal Injury Association (ASIA) B-D, levels between C4 to T1) incurred \> 1 year before the start of the study
- At least 2/5 motor power in at least one upper extremity muscle group
- International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score (ISNCSCI-UEMS) ≤ 40/50
- Able to follow multistep commands
- Ability and willingness to provide informed consent
- English speaking
- Cervical or thoracic stenosis that would preclude safe lead placement
- Any ongoing ventilator use (continuous or intermittent)
- Urinary tract infection or pneumonia requiring treatment (within past 3 months)
- Skin ulcers or other lesions
- History of posterior cervical fusion
- Autonomic dysreflexia requiring treatment (within past 3 months)
- Implanted brain stimulators
- Intracranial aneurysm clips
- Ferromagnetic metallic implants in the head (except for within mouth)
- Any active implanted device including intrathecal medication pumps or existing spinal cord stimulators (does not include non-active spinal instrumentation such as rods, screws, or interbody devices)
- Cochlear implants
- Cardiac pacemaker/defibrillator
- Any history of seizures
- Family history of idiopathic epilepsy in a first degree relative
- Bipolar disorder
- Any history of suicide attempt
- Active psychosis
- Intracranial lesion or increased intracranial pressure
- History of stroke or intracranial neurologic conditions with structural damage
- Medications that lower seizure threshold
- Substance use that lowers seizure threshold (heavy alcohol use)
- Moderate to severe heart disease
- Pregnancy or plans to become pregnant within the study period
- Any other medical or psychological condition that precludes involvement in the study as determined by a study physician
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. 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.