Spinal Cord Associative Plasticity Study (SCAP)
Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy
About this trial
This is an interventional basic science trial for Cervical Spinal Cord Injury focused on measuring spinal cord injury, paired brain and spinal cord stimulation, convergent stimulation, spinal cord associative plasticity, transcutaneous spinal cord stimulation, intraoperative monitoring, upper-limb muscle activation, motor cortex, cervical spinal cord
Eligibility Criteria
NON-INVASIVE
Inclusion Criteria:
(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); provide informed consent.
(Able-bodied participants)
- 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.
Exclusion criteria:
(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; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;
- 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 Classification of Class III or IV;
- 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 heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
- 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)
Sites / Locations
- Bronx Veterans Medical Research Foundation, IncRecruiting
- Columbia University Irving Medical CenterRecruiting
- Weill Cornell MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
1. Uninjured participants - Immediate and lasting effects of non-invasive paired stimulation
2. Intraoperative participants - Immediate effects of paired stimulation
3. Intraoperative participants - Lasting effects of SCAP
4. Chronic cervical SCI participants - Lasting effects of non-invasive SCAP
5. Intraoperative participants - Lasting effects of SCAP at or below myelopathic region
Participants will take part in the following to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Intraoperative pairing of cortical and spinal stimulation.
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP).
Participants with chronic cervical SCI will take part in the following, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region.