Testing spinal cord stimulation and its effects on brain activity
Official title: Clinical Testing and Assessment of the Physiological Effects of Invasive Spinal Cord Stimulation Using Electroencephalography to Optimize Rehabilitation Programs and Develop Personalized Approaches for Recovery After Spinal Injury
Run by Far Eastern Federal University · NCT06725836 · Data updated 2026-11-12
This study is testing if spinal cord stimulation can improve brain activity in people with spinal cord injuries to help them recover better.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Far Eastern Federal University Academic / other |
| Locations | 3 sites (Vladivostok, Primorskiy (Maritime) Kray and 2 other locations) |
| Status | Recruiting |
| Started | April 22, 2023 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | December 10, 2024 |
| Trial ID | NCT06725836 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with either complete or incomplete spinal cord injuries who are scheduled for spinal cord stimulation device implantation.
✕Probably not a fit
Patients with severe somatic pathology, mental disorders, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effects of spinal cord stimulation (SCS) on brain network dysfunctions in patients with spinal cord injuries. Participants will undergo implantation of multichannel electrodes in the epidural space, followed by resting-state electroencephalography (EEG) recordings to assess brain activity before, during, and after stimulation. The goal is to understand neuroplasticity and optimize rehabilitation protocols based on the EEG data collected throughout the rehabilitation process. This approach may lead to personalized recovery strategies for individuals with spinal cord injuries.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation outcomes for patients with spinal cord injuries by tailoring treatment based on individual brain activity patterns.
How similar studies have gone: While the approach of using EEG to assess the effects of spinal cord stimulation is innovative, similar studies have shown promise in understanding neuroplasticity and rehabilitation outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with implanted spinal cord stimulation device * Patients undergoing a scheduled implantation of a spinal cord stimulation device * Complete spinal cord injury * Incomplete spinal cord injury Exclusion Criteria: * Presence of severe somatic pathology that prevents surgical treatment and participation in the study * Presence of mental disorders, severe depression, or a history of suicidal tendencies * History of oncology * History of epilepsy * History of stroke * Inability to perform electrical stimulation due to other somatic pathology * Purulent-septic pathology * Drug addiction (including in the medical history) * Central nervous system developmental anomalies * Any conditions that, in the investigator's opinion, meet the exclusion criteria
Where it's running
-
Federal Autonomous Educational Institution of Higher Education FEFU
Vladivostok, Primorskiy (Maritime) Kray, Russia Recruiting -
Federal Center of Brain Research and Neurotechnologies
Moscow, Russia Recruiting -
Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
Moscow, Russia Active not recruiting
Study contacts
- Principal investigator: Daria Kleeva, Research Fellow — Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
- Study coordinator: Artur Biktimirov, MD
- Email: Biartur2006@yandex.ru
- Phone: 7 914 965 14 88
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.