Actively Recruiting

Phase Not Applicable
All Genders
ID06725836

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

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

35

Participants Needed

3

Research Sites

N/A

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

This research aims to understand brain network problems and how they recover during rehabilitation with spinal cord stimulation (SCS) in people with spinal cord injuries. It focuses on recording resting-state EEG to track brain function changes and explore how brain neuroplasticity plays a role when effective SCS programs are used with implanted electrodes. The study includes participants with either partial or complete spinal cord injuries at various levels. Participants first have resting-state EEG recordings before and after implanting multichannel electrodes into the epidural space below the injury. The spinal cord stimulator is then activated, and optimal stimulation programs are selected to either reduce spasticity or improve voluntary muscle control. Throughout the rehabilitation, EEG recordings are taken before, during, and after stimulation, including a final recording before discharge. The stimulation parameters are adjusted systematically over about two weeks to maximize effectiveness and comfort. During the study, participants follow motor imagery exercises imagining and then performing limb movements while EEG is recorded with the stimulator both off and on. Researchers monitor changes in EEG rhythms and connectivity, focusing on measures like mu rhythm desynchronization. The study also uses clinical scales for neurological function and quality of life at baseline. Postoperative monitoring continues for up to two weeks to ensure safety and track progress. The collected data aims to improve rehabilitation strategies and personalize recovery after spinal cord injury.

CONDITIONS

Brief 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...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implantation

Duration - 1 day

Participants undergo surgery to implant multichannel electrodes into the epidural space of the spinal cord below the injury level and the stimulator is placed in the iliac crest area.

1 surgical visit (in-person)

Post-implantation EEG Assessments

Duration - Up to 2 weeks

Participants have resting-state EEG recordings before the stimulator is turned on and during the selection of the optimal spinal cord stimulation (SCS) program for spastic syndrome suppression and volitional motor control.

Multiple EEG recording sessions during this period

Spinal Cord Stimulation Treatment

Duration - Up to 2 weeks

Participants receive spinal cord stimulation starting on the second day after surgery with adjustments to stimulation parameters for optimal spasticity suppression and voluntary motor control.

Daily stimulator use with periodic visits for program adjustments

Motor Imagery EEG Recording

Duration - Within the 2-week rehabilitation period

Participants perform motor imagery and actual movements with EEG recorded to evaluate mu rhythm desynchronization with stimulator off and on.

1 to 2 EEG recording sessions

Post-operative Follow-up

Duration - Up to 2 weeks

Scheduled monitoring and final resting-state EEG recording with stimulator on before discharge.

Approximately 6 post-operative visits

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

D

Daria Kleeva, Research Fellow

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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Published Research Related To This Trial

Clinical EEG slowing induced by electroconvulsive therapy is better described by increased frontal aperiodic activity.

Sydney E Smith, Vincent Ma, Celene Gonzalez...

https://pubmed.ncbi.nlm.nih.gov/37968263