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

Artur Biktimirov

Status: Enrolling

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

Treatments: Diagnostic Test: Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.; Procedure: Implantation of electrodes into the epidural space for spinal cord stimulation; Diagnostic Test: Electroencephalography within the motor imagery paradigm; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06725836

DVFU-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Spinal Cord Stimulation

Experimental group

Description:

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

Treatment:

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

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

Diagnostic Test: Electroencephalography within the motor imagery paradigm

Procedure: Implantation of electrodes into the epidural space for spinal cord stimulation

Diagnostic Test: Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.