Using spinal cord stimulation and activity training to improve arm function in patients with cervical spinal cord injuries

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 clinical trial investigates the safety and effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) for individuals with acute to subacute cervical spinal cord injuries. Participants will undergo a 10-day regimen of this combined intervention in an inpatient rehabilitation setting, with their progress compared to a sham control and an ABT-only group. The study aims to assess not only the safety and feasibility of the intervention but also its potential to enhance upper extremity function and explore underlying neurophysiological mechanisms. The trial will evaluate changes in cortical and spinal excitability as part of the outcome measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* must be at least 18 years of age.
* must have had a spinal cord injury for less than or equal to 8 weeks.
* must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).
* must have some degree of motor dysfunction in the hand (bilateral UE motor score \<25).
* must be medically stable enough to participate in activity-based recovery training.
* must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.
* must have ability to understand and the willingness to sign an informed consent.

Exclusion Criteria:

* have a history of seizures, head trauma and/or cognitive deficit
* have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
* have a pressure sore or skin issues.
* have severe spasticity.
* in medically unstable condition.
* have a history of illicit drug abuse.
* have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.
* unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).
* unable to meet the attendance requirements.
* currently enrolled in another interventional research study.
* unable to follow instructions and maintain alertness during assessments and training.

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Fan Zhang, PhD
• Email: fzhang@kesslerfoundation.org
• Phone: 4015362070

Similar studies

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

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  This project tests different patterns of brain and nerve electrical stimulation to restore touch and pressure sensations in people with cervical spinal cord injuries who already have ReHAB implants.

  Recruiting Case Western Reserve University · Cleveland, Ohio · NCT07225582

• Non-invasive breathing therapies to improve respiratory function after chronic spinal cord injury

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  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07135583

• Using brain-computer interface technology to improve walking in spinal cord injury patients

  This study is testing a new brain-computer interface system to see if it can help people with spinal cord injuries walk better and improve their quality of life.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT06939660

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.