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New treatment option for Cervical Spinal Cord Injury
Official title Spinal Cord Associative Plasticity Study
ClinicalTrials.gov ID: NCT05163639
What this study is testing
- What it's testing
- Spinal cord associative plasticity (SCAP) is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand function in spinal cord injury. The proposed study will advance understanding of SCAP, which is critical to its effective translation to human therapy.
- Phase 1: an early, usually small safety 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 80. Healthy volunteers may be eligible.
You may be able to join if
- NON-INVASIVE (All participants)
- Age between 18-80 years.
- Must have stable prescription medication for 30 days prior to screening
- Must be able to: abstain from alcohol, smoking and caffeine consumption on the day of each experiment; abstain from recreational drugs for the...
- No known central or peripheral neurological disease or injury. (SCI participants - including patients scheduled for intraoperative procedures)
You likely can't join if
- (All participants)
- Personal or extensive family history of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed...
See the full eligibility criteria
- NON-INVASIVE (All participants)
- Age between 18-80 years.
- Must have stable prescription medication for 30 days prior to screening
- Must be able to: abstain from alcohol, smoking and caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits)...
- No known central or peripheral neurological disease or injury. (SCI participants - including patients scheduled for intraoperative procedures)
- Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
- (All participants)
- Personal or extensive family history of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines...
- Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional...
- Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in...
- History of significant hearing problems;
- History of bipolar disorder;
- History of suicide attempt;
- Active psychosis;
- Recent history (\>1 year) of chemical substance dependency or significant psychosocial disturbance;
- Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
- Open skin lesions over the face, neck, shoulders, or arms;
- Pregnancy; and
- Unsuitable for study participation as determined by study physician. INTRA-OPERATIVE Inclusion Criteria:
- Clinical indication for cervical spine surgery. Exclusion criteria: (For experiments involving cortical stimulation)
- Epilepsy;
- A history of skull surgery with metal implants;
- Cochlear implants;
- Patients with aneurysm stents in neck or brain blood vessels;
- Evidence of skull shrapnel; (For experiments involving spinal cord stimulation)
- Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)
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 to 80 years. Healthy volunteers may be eligible. 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.