Exploring spinal cord stimulation and training for 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 project aims to investigate how spinal cord stimulation (SCS) affects neural circuits involved in motor function improvements for individuals with spinal cord injuries (SCI). The study will assess both short-term excitability and long-term plasticity of corticospinal, reticulospinal, and spinal neural circuits through various interventions, including electrophysiology assessments and activity-based training. By understanding the neural mechanisms enhanced by SCS, the research seeks to develop targeted therapies that promote recovery in individuals with chronic SCI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Healthy Volunteers

* Age between 16 and 65 years old
* Healthy people with no major comorbidities of any organ system

Exclusion Criteria:

Healthy Volunteers

* Subjects younger than 16 or older than 65 years old
* Subjects not providing consent or not able to consent
* Subjects with any acute or chronic pain condition
* Subjects with any acute or chronic disease of a major organ system
* Use of analgesics within 24 hours prior to study period
* Use of caffeine with 3 hours of study appointment

Inclusion criteria:

Participants with spinal cord injury (SCI)

* Age between 16-65 years old
* Traumatic SCI C4-T9 level, incomplete (ASIA C or D)
* at least 1 year post injury
* Stable medical condition
* difficulty independently performing leg movements in routine activities
* able to follow simple commands
* able to speak and respond to questions

Exclusion criteria:

Participants with spinal cord injury (SCI)

* Subjects younger than 16 or older than 65 years old
* Not willing or able to provide consent
* Any acute or chronic pain condition
* Any acute or chronic disease of a major organ system
* Use of analgesics within 24 hours prior to study appointment
* Use of caffeine with 3 hours of study appointment
* Presence of tremors, spasms and other significant involuntary movements
* Etiology of SCI other than trauma
* Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
* History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc).
* Severe joint contractures disabling or restricting lower limb movements.
* Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
* Depression, anxiety, or cognitive impairment
* Deficit of visuospatial orientation
* Sitting tolerance less than 1 hour
* Severe hearing or visual deficiency
* Miss more than 3 appointments without notification
* Unable to comply with any of the procedures in the protocol
* Botulinum toxin injection in lower extremity muscles in the prior six months
* Any passive implants (osteosynthesis material, metallic plates or screws) below T9.
* Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
* History of alcoholism or another drug abuse
* Pregnancy (or possible pregnancy)
* Having an Intrathecal Baclofen Therapy Pump (ITB pump)
* History of epilepsy

Where it's running

• Washington University
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Ismael Seanez, PhD — Washington University School of Medicine
• Study coordinator: Ismael Seanez, PHD
• Email: ismaelseanez@wustl.edu
• Phone: 314-935-7665

Similar studies

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

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• ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab

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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.