Actively Recruiting

Phase Not Applicable
All Genders
NCT06725836

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

Led by Artur Biktimirov · Updated on 2024-12-10

35

Participants Needed

3

Research Sites

292 weeks

Total Duration

On this page

Sponsors

A

Artur Biktimirov

Lead Sponsor

S

Skolkovo Institute of Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Severe somatic conditions preventing surgery or study participation
  • Mental disorders, severe depression, or history of suicidal tendencies
  • History of cancer
  • History of epilepsy
  • History of stroke
  • Inability to undergo electrical stimulation due to other somatic conditions
  • Purulent-septic infections
  • Drug addiction including history
  • Central nervous system developmental anomalies
  • Any conditions deemed exclusionary by the investigator

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Federal Autonomous Educational Institution of Higher Education FEFU

Vladivostok, Primorskiy (Maritime) Kray, Russia, 690922

Actively Recruiting

2

Federal Center of Brain Research and Neurotechnologies

Moscow, Russia, 117513

Actively Recruiting

3

Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology

Moscow, Russia, 121205

Active, Not Recruiting

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Research Team

A

Artur Biktimirov, MD

CONTACT

D

Daria Kleeva, Research Fellow

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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