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

NCT06725836 | Recruiting

• 1 other identifier: DVFU-04
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

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

Spinal Cord Injuries (SCI); Spinal Cord Injury

Keywords

Spinal Cord Stimulation; Electric Stimulation Therapy; Spinal Cord Injuries; Rehabilitation; Brain Waves; Central Nervous System; EEG

Outcome Measures

Primary Outcomes (4)

• Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed

  Electroencephalography (EEG) spectral power in standard frequency bands (1-40 Hz) will be analyzed across different conditions: stimulator on vs. off, and eyes open vs. closed. Independent component analysis (ICA) will be used for artifact removal, followed by spectral power computation and normalization.

  Up to 2 weeks

• Spatial distribution of electroencephalography rhythms in standard frequency bands during neurostimulator turned on/off and with eyes open/closed

  This outcome evaluates the spatial patterns of electroencephalography (EEG) rhythms across the scalp in standard frequency bands. Independent component analysis (ICA) will correct artifacts, and spatial maps of EEG power will be compared between the neurostimulation conditions (on/off) and different visual states (eyes open/closed). This analysis will help identify brain regions influenced by SCS.

  Up to 2 weeks

• Functional connectivity measures in standard frequency bands (imaginary part of coherence, PLV, etc.) during neurostimulation on/off and with eyes open/closed

  Functional connectivity between brain regions will be measured using metrics such as coherence and phase-locking value (PLV) in standard frequency bands. The analysis will focus on how connectivity patterns change with the stimulator on vs. off and eyes open vs. closed, providing insights into network-level effects of spinal cord stimulation.

  Up to 2 weeks

• Mu rhythm desynchronization within the motor imagery paradigm during neurostimulation on/off and with eyes open/closed

  Changes in mu rhythm desynchronization during motor imagery will be evaluated as a marker of motor cortex engagement. Electroencephalography (EEG) will be recorded during imagined limb movements, with and without neurostimulation. The comparison will determine the effect of spinal cord stimulation (SCS) on motor-related brain activity.

  Up to 2 weeks

Secondary Outcomes (4)

• American Spine Injury Association / International Standards for Neurological and Functional Classification of Spinal Cord Injury (ASIA/ISCSCI)

  Baseline

• The Short Form-36 (SF-36)

  Baseline

• Spinal Cord Independence Measure III (SCIM-III)

  Baseline

• The Neurogenic Bladder Symptom Score (NBSS)

  Baseline

Study Arms (1)

Spinal Cord Stimulation

EXPERIMENTAL

Patients with clinical presentations of complete and incomplete spinal cord injury.

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

Interventions

Implantation of electrodes into the epidural space for spinal cord stimulation PROCEDURE

Under X-ray guidance and with neurophysiological supervision, the electrode is implanted. The stimulator is surgically placed in a pocket formed in the iliac crest area on the left side, where it is secured. The generator is connected to an electrode array positioned on the dorsal epidural surface of the spinal cord at the appropriate level (sacral-lumbar/cervical region), as confirmed by intraoperative fluoroscopy.

Spinal Cord Stimulation

Selection of the optimal spinal cord stimulation program for spastic syndrome suppression PROCEDURE

During the selection of the optimal stimulation program for spasticity suppression, spinal cord stimulation (SCS) is performed at various sites on the electrode array. Stimulation is initiated at a specific site with a frequency of 60 Hz, and the intensity is gradually increased until the spasticity is alleviated (i.e., the limb can flex and extend without restriction). If there is no effect, the stimulation frequency is increased by 5 Hz, and the intensity is again adjusted from 0 to comfortable values. Stimulation is sequentially applied at different sites, and those sites where muscle spasticity is most effectively suppressed are selected.

Spinal Cord Stimulation

Selection of the optimal spinal cord stimulation program for volitional motor control PROCEDURE

Over the course of two weeks, the configuration of the electrodes and the intensity of the stimulation are adjusted to ensure optimal voluntary muscle control. A systematic approach is used to determine the most suitable settings. First, the anodes and cathodes on the electrode array are identified. The desired frequency range is 20-40 Hz. The pulse width is determined empirically. The adjustment begins at 20 Hz, with the stimulation intensity gradually increased. If unpleasant sensations (such as muscle spasms or pain) occur, the intensity is reduced to comfortable values. If there is no effect, the stimulation frequency is increased by 5 Hz, and the intensity is adjusted again from 0 to comfortable levels. Stimulation is sequentially applied at different sites, with the sites that provide the most effective voluntary muscle control being selected.

Spinal Cord Stimulation

Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation. DIAGNOSTIC_TEST

The procedure utilizes the method of electroencephalography (EEG). Throughout the procedure, EEG signals are recorded. Initially, the participant is recorded in a resting state before the implantation of the stimulator for 20 minutes (5 minutes with eyes open, followed by 5 minutes with eyes closed). After the surgery, the participant is recorded in the same manner before the first activation of the stimulator. After selecting the programs, the participant is recorded without stimulation (eyes open, then closed), followed by recordings with the spinal cord stimulator (SCS) activated (eyes open, then closed). The stimulation is then turned off again, and recording is conducted with eyes open and closed. Before discharge, the participant is recorded in a resting state for 20 minutes with the stimulation program active.

Spinal Cord Stimulation

Electroencephalography within the motor imagery paradigm DIAGNOSTIC_TEST

The procedure utilizes the method of electroencephalography (EEG). Throughout the procedure, EEG signals are recorded. During the experiment, with the stimulator turned off, the participant views a fixation cross on a computer screen. Then, they hear an auditory signal and see a sign indicating a specific movement (complete flexion and extension of the left arm, complete flexion and extension of the right arm, complete flexion and extension of the left leg, complete flexion and extension of the right leg). The participant imagines the movements according to the auditory and visual signals on the screen. Subsequently, the participant performs the same movements in the same order. The motor control stimulation program is then activated, and the entire sequence is repeated (first imagining the movement, then performing the imagined movements). The timing of the command presentations is recorded with marker placements.

Spinal Cord Stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artur Biktimirov: lead
• Skolkovo Institute of Science and Technology: collaborator
• The Federal Center of Brain Research and Neurotechnologies: collaborator

Study Sites (3)

Federal Autonomous Educational Institution of Higher Education FEFU

Vladivostok, Primorskiy (Maritime) Kray, 690922, Russia

RECRUITING

Federal Center of Brain Research and Neurotechnologies

Moscow, 117513, Russia

RECRUITING

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

Moscow, 121205, Russia

ACTIVE NOT RECRUITING

Related Publications (4)

• Smith SE, Ma V, Gonzalez C, Chapman A, Printz D, Voytek B, Soltani M. Clinical EEG slowing induced by electroconvulsive therapy is better described by increased frontal aperiodic activity. Transl Psychiatry. 2023 Nov 16;13(1):348. doi: 10.1038/s41398-023-02634-9.

  PMID: 37968263 BACKGROUND

• Simis M, Doruk Camsari D, Imamura M, Filippo TRM, Rubio De Souza D, Battistella LR, Fregni F. Electroencephalography as a Biomarker for Functional Recovery in Spinal Cord Injury Patients. Front Hum Neurosci. 2021 Apr 9;15:548558. doi: 10.3389/fnhum.2021.548558. eCollection 2021.

  PMID: 33897390 BACKGROUND

• Jensen MP, Sherlin LH, Gertz KJ, Braden AL, Kupper AE, Gianas A, Howe JD, Hakimian S. Brain EEG activity correlates of chronic pain in persons with spinal cord injury: clinical implications. Spinal Cord. 2013 Jan;51(1):55-8. doi: 10.1038/sc.2012.84. Epub 2012 Jul 17.

  PMID: 22801188 BACKGROUND

• Lopez-Larraz E, Montesano L, Gil-Agudo A, Minguez J, Oliviero A. Evolution of EEG Motor Rhythms after Spinal Cord Injury: A Longitudinal Study. PLoS One. 2015 Jul 15;10(7):e0131759. doi: 10.1371/journal.pone.0131759. eCollection 2015.

  PMID: 26177457 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Artur Biktimirov, MD

  Federal Autonomous Educational Institution of Higher Education FEFU; Federal Center of Brain Research and Neurotechnologies

  STUDY CHAIR

• Mikhail Lebedev, PhD

  Faculty of Mechanics and Mathematics, Lomonosov Moscow State University

  STUDY DIRECTOR

• Daria Kleeva, Research Fellow

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

  PRINCIPAL INVESTIGATOR

• Alexander Kaplan, D.Sci., Ph.D.

  Faculty of Biology, Lomonosov Moscow State University

  STUDY DIRECTOR

Central Study Contacts

Artur Biktimirov, MD

CONTACT

7 914 965 14 88; Biartur2006@yandex.ru

Daria Kleeva, Research Fellow

CONTACT

7 931 359 70 09; dkleeva@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Laboratory of Experimental and Translational Medicine of Far Eastern Federal University (FEFU)

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: April 22, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)