Clinical trial NCT06725836: Clinical Testing of Invasive Spinal Cord Stimulation and Evaluation of Its Physiological Effects Using the Electroencephalography
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Spinal Cord Injury
Keywords: Spinal Cord Stimulation
Electric Stimulation Therapy
Spinal Cord Injuries
Rehabilitation
Brain Waves
Central Nervous System
EEG
Lead sponsor: Far Eastern Federal University
Sponsor class: OTHER
Collaborators: name: Skolkovo Institute of Science and Technology
name: The Federal Center of Brain Research and Neurotechnologies
First posted: 2024-12-10
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed
timeFrame: Up to 2 weeks
measure: Spatial distribution of electroencephalography rhythms in standard frequency bands during neurostimulator turned on/off and with eyes open/closed
timeFrame: Up to 2 weeks
measure: Functional connectivity measures in standard frequency bands (imaginary part of coherence, PLV, etc.) during neurostimulation on/off and with eyes open/closed
timeFrame: Up to 2 weeks
measure: Mu rhythm desynchronization within the motor imagery paradigm during neurostimulation on/off and with eyes open/closed
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: American Spine Injury Association / International Standards for Neurological and Functional Classification of Spinal Cord Injury (ASIA/ISCSCI)
timeFrame: Baseline
measure: The Short Form-36 (SF-36)
timeFrame: Baseline
measure: Spinal Cord Independence Measure III (SCIM-III)
timeFrame: Baseline
measure: The Neurogenic Bladder Symptom Score (NBSS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Vladivostok
country: Russian Federation
facility: Federal Autonomous Educational Institution of Higher Education FEFU
state: Primorsky Krai
city: Moscow
country: Russian Federation
facility: Federal Center of Brain Research and Neurotechnologies
city: Moscow
country: Russian Federation
facility: Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
Study officials:
affiliation: Federal Autonomous Educational Institution of Higher Education FEFU; Federal Center of Brain Research and Neurotechnologies
name: Artur Biktimirov, MD
role: STUDY_CHAIR
affiliation: Faculty of Mechanics and Mathematics, Lomonosov Moscow State University
name: Mikhail Lebedev, PhD
role: STUDY_DIRECTOR
affiliation: Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
name: Daria Kleeva, Research Fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Biology, Lomonosov Moscow State University
name: Alexander Kaplan, D.Sci., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.