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Clinical Testing of Invasive Spinal Cord Stimulation and Evaluation of Its Physiological Effects Using the Electroencephalography

RecruitingNAAges any - anyAllArtur Biktimirov
NCT06725836 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the study is to identify the specific characteristics of brain network dysfunctions and assess the recovery of their functionality through the recording of resting-state electroencephalography (EEG) during rehabilitation using spinal cord stimulation (SCS). Researchers expect that effective SCS scenarios will result in progressive alterations in the quantitative metrics of resting-state EEG throughout the rehabilitation period. The data obtained may be used to optimize rehabilitation protocols and develop personalized approaches for recovery after spinal cord injury.

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📋 Eligibility rules (as published)
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
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What it tests

  • Implantation of electrodes into the epidural space for spinal cord stimulation
  • Selection of the optimal spinal cord stimulation program for spastic syndrome suppression
  • Selection of the optimal spinal cord stimulation program for volitional motor control
  • Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.
  • Electroencephalography within the motor imagery paradigm
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Where

3 sites
Federal Autonomous Educational Institution of Higher Education FEFU
Vladivostok, Russia
Federal Center of Brain Research and Neurotechnologies
Moscow, Russia
Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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