Spinal Cord Injuries (SCI)NCT06725836
Clinical Testing of Invasive Spinal Cord Stimulation and Evaluation of Its Physiological Effects Using the Electroencephalography
A study testing Implantation of electrodes into the epidural space for spinal cord stimulation, Selection of the optimal spinal cord stimulation program for spastic syndrome suppression and Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation. in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by Artur Biktimirov at 3 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries (SCI), Spinal Cord Injury
- What is being tested?
- Implantation of electrodes into the epidural space for spinal cord stimulation, Selection of the optimal spinal cord stimulation program for spastic syndrome suppression and Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesRussia
- Study dates
- 22 Apr 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia3 sites, 2 recruiting
- Recruiting
Federal Center of Brain Research and Neurotechnologies
Moscow, 117513
Artur Biktimirov, MD, 7 914 965 14 88, Biartur2006@yandex.ru
- Active, not recruiting
Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
Moscow, 121205
- Recruiting
Federal Autonomous Educational Institution of Higher Education FEFU
Vladivostok, Primorskiy (Maritime) Kray, 690922
Artur Biktimirov, MD, 7 914 965 1488, Biartur2006@yandex.ru
Nikita Kozulin, Student
About this study
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
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.
Read the 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
- Being tested
- Implantation of electrodes into the epidural space for spinal cord stimulation, Selection of the optimal spinal cord stimulation program for spastic syndrome suppression, Selection of the optimal spinal cord stimulation program for volitional motor control, Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation., Electroencephalography within the motor imagery paradigm
- Keywords
- Spinal Cord Stimulation, Electric Stimulation Therapy, Spinal Cord Injuries, Rehabilitation, Brain Waves, Central Nervous System, EEG
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of electrodes into the epidural space for spinal cord stimulationProcedure or surgery
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.
Selection of the optimal spinal cord stimulation program for spastic syndrome suppressionProcedure or surgery
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.
Selection of the optimal spinal cord stimulation program for volitional motor controlProcedure or surgery
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.
Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.Diagnostic test
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.
Electroencephalography within the motor imagery paradigmDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Patients with clinical presentations of complete and incomplete spinal cord injury. Receives: Procedure: Implantation of electrodes into the epidural space for spinal cord stimulation; 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; Diagnostic Test: Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation.; Diagnostic Test: Electroencephalography within the motor imagery paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral characteristics of resting electroencephalography in standard frequency bands during neurostimulator turned on/off and with eyes open/closed
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.
Measured: Up to 2 weeks
Spatial distribution of electroencephalography rhythms in standard frequency bands during neurostimulator turned on/off and with eyes open/closed
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.
Measured: 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
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.
Measured: Up to 2 weeks
Mu rhythm desynchronization within the motor imagery paradigm during neurostimulation on/off and with eyes open/closed
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.
Measured: Up to 2 weeks
Secondary outcomes (4)
American Spine Injury Association / International Standards for Neurological and Functional Classification of Spinal Cord Injury (ASIA/ISCSCI)
The ASIA/ISNCSCI is a standardized quantitative system for assessing the neurological status of patients with spinal cord injuries. The assessment algorithm involves sequential determination of the following: sensory levels of injury on the right and left sides by dermatome (where 0 - absent, 1 - impaired/altered sensation (reduced or hypersensitivity), and 2 - normal sensation); motor levels of injury on the right and left sides (ranging from 0, which represents complete paralysis, to 5, which represents normal active movement); the neurological level of injury; completeness of injury (complete or incomplete); and the degree of spinal cord injury (A - complete injury; B - complete absence of motor function but with preserved sensation; C - significant motor function impairment with preserved sensation; D - mild motor impairments with normal sensation and functionally significant movements; E - sensation and motor function are graded as normal).
Measured: Baseline
The Short Form-36 (SF-36)
The Short Form-36 consists of eight scales: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role function, and mental health. Each scale ranges from 0 (worst possible score) to 100 (best possible score).
Measured: Baseline
Spinal Cord Independence Measure III (SCIM-III)
The SCIM-III scale consists of three subscales: self-care (eating, bathing, dressing), respiration and sphincter management, and mobility (in bed and transfers in/out of the room). The results are determined by summing the points of all items, yielding a total score (ranging from 0 to 100) and/or by summing the subscale scores (self-care: 0-20; respiration and sphincter management: 0-40; mobility: 0-40).
Measured: Baseline
The Neurogenic Bladder Symptom Score (NBSS)
The NBSS scale allows for the assessment of symptom severity regardless of the type of neurogenic dysfunction and whether or not the patient has voluntary urination. The scale consists of 24 items that measure bladder symptoms across 3 different domains: incontinence (ranging from 0 to 29), storage and voiding (from 0 to 22), and consequences (from 0 to 23). There is also a single general question about quality of life related to urination, rated on a scale from 0 (satisfied) to 4 (dissatisfied). For all domains, a higher score indicates a more severe symptom burden or a greater negative impact on quality of life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start22 Apr 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artur Biktimirov
- Sponsor type
- University, hospital or other
- Collaborators
- Skolkovo Institute of Science and Technology, The Federal Center of Brain Research and Neurotechnologies
- Responsible party
- Sponsor-investigator, Artur Biktimirov, Far Eastern Federal University
- Investigators
- Artur Biktimirov, MD, Study chair, Federal Autonomous Educational Institution of Higher Education FEFU; Federal Center of Brain Research and NeurotechnologiesMikhail Lebedev, PhD, Study director, Faculty of Mechanics and Mathematics, Lomonosov Moscow State UniversityDaria Kleeva, Research Fellow, Principal investigator, Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and TechnologyAlexander Kaplan, D.Sci., Ph.D., Study director, Faculty of Biology, Lomonosov Moscow State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725836
- Sponsor's protocol ID
- DVFU-04
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37968263Simis 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.
PubMed 33897390Jensen 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.
PubMed 22801188Lopez-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.
PubMed 26177457
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06725836
- Acronym / sponsor ID
- DVFU-04
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Artur BiktimirovUniversity, hospital or other
- Collaborators
- Skolkovo Institute of Science and Technology, The Federal Center of Brain Research and Neurotechnologies
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Procedure: Implantation of electrodes into the epidural space for spinal cord stimulation, 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, Diagnostic Test: Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation., Diagnostic Test: Electroencephalography within the motor imagery paradigmPatients with clinical presentations of complete and incomplete spinal cord injury. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of electrodes into the epidural space for spinal cord stimulationUnder 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 or surgery | Spinal Cord Stimulation |
| Selection of the optimal spinal cord stimulation program for spastic syndrome suppressionDuring 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 or surgery | Spinal Cord Stimulation |
| Selection of the optimal spinal cord stimulation program for volitional motor controlOver 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. | Procedure or surgery | Spinal Cord Stimulation |
| 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 | Spinal Cord Stimulation |
| Electroencephalography within the motor imagery paradigmThe 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. | Diagnostic test | Spinal Cord Stimulation |
Primary outcome
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.
4 secondary outcomes
American Spine Injury Association / International Standards for Neurological and Functional Classification of Spinal Cord Injury (ASIA/ISCSCI)
Time frame: Baseline
The Short Form-36 (SF-36)
Time frame: Baseline
Spinal Cord Independence Measure III (SCIM-III)
Time frame: Baseline
The Neurogenic Bladder Symptom Score (NBSS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 37968263Smith 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.
- Background: PubMed 33897390Simis 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.
- Background: PubMed 22801188Jensen 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.
- Background: PubMed 26177457Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Artur Biktimirov, MD study chair
Federal Autonomous Educational Institution of Higher Education FEFU; Federal Center of Brain Research and Neurotechnologies
Mikhail Lebedev, PhD study director
Faculty of Mechanics and Mathematics, Lomonosov Moscow State University
Daria Kleeva, Research Fellow principal investigator
Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of electrodes into the epidural space for spinal cord stimulation, Selection of the optimal spinal cord stimulation program for spastic syndrome suppression and Resting electroencephalography for identifying neurocorrelates of spinal cord stimulation. in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by Artur Biktimirov at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artur Biktimirov, MD (7 914 965 14 88, Biartur2006@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06725836, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.