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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries (SCI); Spinal Cord Injury

• Registration Number: NCT06725836
• Lead Sponsor: Artur Biktimirov

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.

Detailed Description

The aim of the study is to identify the nature of brain network dysfunctions and assess the recovery of their function based on resting-state electroencephalography (EEG) recordings during rehabilitation using spinal cord stimulation (SCS).

The study aims to gather information on the role of brain neuroplasticity during the use of effective SCS programs with implanted electrodes in participants with partial or complete spinal cord injury at various levels.

Participants are enrolled according to inclusion criteria. Before the procedure for implanting multichannel electrodes, resting-state EEG recordings are performed. Then, multichannel electrodes are implanted into the epidural space of the spinal cord below the level of injury. After the implantation, another resting-state EEG recording is conducted before the stimulator is turned on for the first time. Once the optimal SCS program is selected (for the suppression of spastic syndrome or volitional motor control), periodic resting-state EEG recordings are made: before stimulation, during stimulation, and after stimulation. Before the participant is discharged, a final resting-state EEG recording is performed with the stimulator turned on. Scheduled postoperative monitoring will be conducted for up to 2 weeks.

SCS is initiated on the second day after the surgical procedure. The participant is instructed on the use of the stimulator. The optimal program is selected within commonly accepted ranges of stimulation parameters (frequency, amplitude, pulse width) based on maximum efficacy.

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.

Within the motor imagery paradigm, following the selection of the program for volitional motor control, participants are instructed to sequentially imagine movements of the limbs (general flexion and extension of the left arm, general flexion and extension of the right arm, general flexion and extension of the left leg, and general flexion and extension of the right leg) in response to auditory and visual cues displayed on a computer screen. After imagining these movements, participants are required to physically perform the same movements. Recordings are made with the stimulator both turned off and on. Throughout the entire recording period, EEG is continuously recorded from the participant. The primary aim of this recording is to investigate the desynchronization of the mu rhythm.

Study Timeline

• Study Start: 2023-04-22
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed	Up to 2 weeks	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.
Spatial distribution of electroencephalography rhythms in standard frequency bands during neurostimulator turned on/off and with eyes open/closed	Up to 2 weeks	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.
Functional connectivity measures in standard frequency bands (imaginary part of coherence, PLV, etc.) during neurostimulation on/off and with eyes open/closed	Up to 2 weeks	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.
Mu rhythm desynchronization within the motor imagery paradigm during neurostimulation on/off and with eyes open/closed	Up to 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
American Spine Injury Association / International Standards for Neurological and Functional Classification of Spinal Cord Injury (ASIA/ISCSCI)	Baseline	The ASIA/ISNCSCI is a standardized quantitative system for assessing the neurological status of patients with spinal cord injuries. The assessment algorithm involves sequential determination of the following: sensory levels of injury on the right and left sides by dermatome (where 0 - absent, 1 - impaired/altered sensation (reduced or hypersensitivity), and 2 - normal sensation); motor levels of injury on the right and left sides (ranging from 0, which represents complete paralysis, to 5, which represents normal active movement); the neurological level of injury; completeness of injury (complete or incomplete); and the degree of spinal cord injury (A - complete injury; B - complete absence of motor function but with preserved sensation; C - significant motor function impairment with preserved sensation; D - mild motor impairments with normal sensation and functionally significant movements; E - sensation and motor function are graded as normal).
The Short Form-36 (SF-36)	Baseline	The Short Form-36 consists of eight scales: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role function, and mental health. Each scale ranges from 0 (worst possible score) to 100 (best possible score).
Spinal Cord Independence Measure III (SCIM-III)	Baseline	The SCIM-III scale consists of three subscales: self-care (eating, bathing, dressing), respiration and sphincter management, and mobility (in bed and transfers in/out of the room). The results are determined by summing the points of all items, yielding a total score (ranging from 0 to 100) and/or by summing the subscale scores (self-care: 0-20; respiration and sphincter management: 0-40; mobility: 0-40).
The Neurogenic Bladder Symptom Score (NBSS)	Baseline	The NBSS scale allows for the assessment of symptom severity regardless of the type of neurogenic dysfunction and whether or not the patient has voluntary urination. The scale consists of 24 items that measure bladder symptoms across 3 different domains: incontinence (ranging from 0 to 29), storage and voiding (from 0 to 22), and consequences (from 0 to 23). There is also a single general question about quality of life related to urination, rated on a scale from 0 (satisfied) to 4 (dissatisfied). For all domains, a higher score indicates a more severe symptom burden or a greater negative impact on quality of life.

Trial Locations

Locations (3)

Federal Autonomous Educational Institution of Higher Education FEFU; 🇷🇺 Vladivostok, Primorsky Krai, Russian Federation

Federal Center of Brain Research and Neurotechnologies; 🇷🇺 Moscow, Russian Federation

Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology; 🇷🇺 Moscow, Russian Federation