Improving hand function after spinal cord injury using electrical stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates spinal cord associative plasticity (SCAP), a technique that combines cortical and spinal electrical stimulation to enhance recovery of arm and hand function in individuals with cervical spinal cord injuries. The research aims to determine if electrical stimulation can strengthen signaling through the spinal cord to the muscles and improve understanding of spinal cord function. Participants will undergo both non-invasive and intraoperative stimulation to assess the effects of paired brain and spinal cord stimulation on muscle activation and movement recovery. The study seeks to translate promising animal research into human therapy for those with paralysis or weakness following spinal cord injury.

Why it matters

Who can join: the full rules

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)

Where it's running

• Bronx Veterans Medical Research Foundation, Inc
  New York, New York, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jason B Carmel, M.D., Ph.D. — Columbia University
• Study coordinator: Jason B Carmel, M.D., Ph.D.
• Email: jbc28@cumc.columbia.edu
• Phone: 917-301-1882

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cervical spinal cord stimulation for improving arm and hand function

  This study is testing different ways of using spinal cord stimulation to see if it can help people with cervical spinal cord injuries improve their arm and hand function.

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• Robotically implanted Neuralink N1 brain-computer interface to control external devices

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• Robotically implanted brain chip to help control external devices

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• Robotically implanted brain-computer interface for controlling devices

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.