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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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 comfortabl
• Процедура 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
• Диагностический тест 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 o
• Диагностический тест 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

Первичные конечные точки

• Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed [Срок оценки: Up to 2 weeks]
• Spatial distribution of electroencephalography rhythms in standard frequency bands during neurostimulator turned on/off and with eyes open/closed [Срок оценки: 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 [Срок оценки: Up to 2 weeks]
• Mu rhythm desynchronization within the motor imagery paradigm during neurostimulation on/off and with eyes open/closed [Срок оценки: Up to 2 weeks]

Вторичные конечные точки (4)

• American Spine Injury Association / International Standards for Neurological and Functional Classification of Spinal Cord Injury (ASIA/ISCSCI) [Срок оценки: Baseline]
• The Short Form-36 (SF-36) [Срок оценки: Baseline]
• Spinal Cord Independence Measure III (SCIM-III) [Срок оценки: Baseline]
• The Neurogenic Bladder Symptom Score (NBSS) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Россия · 3 центра

• Federal Autonomous Educational Institution of Higher Education FEFU — Vladivostok
• Federal Center of Brain Research and Neurotechnologies — Moscow
• Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Sc — Moscow

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06725836 · DVFU-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗