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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 5
- Primary Endpoint
- Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
Investigators
Artur Biktimirov
Head of the Laboratory of Experimental and Translational Medicine of Far Eastern Federal University (FEFU)
Far Eastern Federal University