RECRUITING

Spinal Cord Associative Plasticity Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Spinal Cord Associative Plasticity Study

Quick Facts

Study Start:2021-09-10
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05163639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 18-80 years.
  2. * Must have stable prescription medication for 30 days prior to screening
  3. * 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.
  4. * No known central or peripheral neurological disease or injury.
  5. * Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
  1. * Personal or extensive family history of seizures;
  2. * Ventilator dependence or patent tracheostomy site;
  3. * Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
  4. * History of stroke, brain tumor, brain abscess, or multiple sclerosis;
  5. * 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);
  6. * 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;
  7. * 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;
  8. * 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);
  9. * History of significant hearing problems;
  10. * History of bipolar disorder;
  11. * History of suicide attempt;
  12. * Active psychosis;
  13. * Recent history (\>1 year) of chemical substance dependency or significant psychosocial disturbance;
  14. * Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
  15. * Open skin lesions over the face, neck, shoulders, or arms;
  16. * Pregnancy; and
  17. * Unsuitable for study participation as determined by study physician.

Contacts and Locations

Study Contact

Jason B Carmel, M.D., Ph.D.
CONTACT
917-301-1882
jbc28@cumc.columbia.edu
Noam Y Harel, M.D., Ph.D.
CONTACT
212-241-7317
noam.harel@mssm.edu

Principal Investigator

Jason B Carmel, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Bronx Veterans Medical Research Foundation, Inc
New York, New York, 10029
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Jason B Carmel, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-10
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-09-10
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Cervical Spinal Cord Injury
  • Tetraplegia/Tetraparesis
  • Cervical Myelopathy