NCT06725836

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Artur Biktimirov · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries (SCI)
• Spinal Cord Injury

Interventions

Type	Name	Description
PROCEDURE	Implantation of electrodes into the epidural space for spinal cord stimulation	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.
PROCEDURE	Selection of the optimal spinal cord stimulation program for spastic syndrome suppression	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.
PROCEDURE	Selection of the optimal spinal cord stimulation program for volitional motor control	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.
DIAGNOSTIC_TEST	Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.	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.
DIAGNOSTIC_TEST	Electroencephalography within the motor imagery paradigm	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.

Timeline

• Start date: 2023-04-22
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

3 sites across 1 country: Russia