Spinal Cord Associative Plasticity Study

Recruiting now · Early Phase 1

Conditions studied: Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy

In brief

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. The purpose of the study is to: 1. Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation. 2. Improve our understanding of the spinal cord and how it produces movement. 3. Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function. Aim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity (SCAP). Aim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing. In rats, SCAP augments muscle activation for hours after just 5 minutes of paired stimuli. Whereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord, Aim 3 assesses whether paired stimulation can be effective across injured cord segments. Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI, either traumatic or pre-operative patients with myelopathy in non-invasive experiments, or targeting myelopathic segments in intraoperative segments.

Key facts

Study ID

NCT05163639

Run by

Columbia University

People needed

92

Starts

2021-09-10

Expected to finish

2027-12-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• (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.

You may not qualify 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 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;

Where it is running

• Bronx Veterans Medical Research Foundation, Inc — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.