Clinical EEG slowing induced by electroconvulsive therapy is better described by increased frontal aperiodic activity.
Sydney E Smith, Vincent Ma, Celene Gonzalez...
https://pubmed.ncbi.nlm.nih.gov/37968263Actively Recruiting
Led by Artur Biktimirov · Updated on 2024-12-10
35
Participants Needed
3
Research Sites
N/A
Total Duration
A
Artur Biktimirov
Lead Sponsor
S
Skolkovo Institute of Science and Technology
Collaborating Sponsor
This research aims to understand brain network problems and how they recover during rehabilitation with spinal cord stimulation (SCS) in people with spinal cord injuries. It focuses on recording resting-state EEG to track brain function changes and explore how brain neuroplasticity plays a role when effective SCS programs are used with implanted electrodes. The study includes participants with either partial or complete spinal cord injuries at various levels. Participants first have resting-state EEG recordings before and after implanting multichannel electrodes into the epidural space below the injury. The spinal cord stimulator is then activated, and optimal stimulation programs are selected to either reduce spasticity or improve voluntary muscle control. Throughout the rehabilitation, EEG recordings are taken before, during, and after stimulation, including a final recording before discharge. The stimulation parameters are adjusted systematically over about two weeks to maximize effectiveness and comfort. During the study, participants follow motor imagery exercises imagining and then performing limb movements while EEG is recorded with the stimulator both off and on. Researchers monitor changes in EEG rhythms and connectivity, focusing on measures like mu rhythm desynchronization. The study also uses clinical scales for neurological function and quality of life at baseline. Postoperative monitoring continues for up to two weeks to ensure safety and track progress. The collected data aims to improve rehabilitation strategies and personalize recovery after spinal cord injury.
CONDITIONS
Clinical Testing of Invasive Spinal Cord Stimulation and Evaluation of Its Physiological Effects Using the Electroencephalography
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgery to implant multichannel electrodes into the epidural space of the spinal cord below the injury level and the stimulator is placed in the iliac crest area.
1 surgical visit (in-person)
Duration - Up to 2 weeks
Participants have resting-state EEG recordings before the stimulator is turned on and during the selection of the optimal spinal cord stimulation (SCS) program for spastic syndrome suppression and volitional motor control.
Multiple EEG recording sessions during this period
Duration - Up to 2 weeks
Participants receive spinal cord stimulation starting on the second day after surgery with adjustments to stimulation parameters for optimal spasticity suppression and voluntary motor control.
Daily stimulator use with periodic visits for program adjustments
Duration - Within the 2-week rehabilitation period
Participants perform motor imagery and actual movements with EEG recorded to evaluate mu rhythm desynchronization with stimulator off and on.
1 to 2 EEG recording sessions
Duration - Up to 2 weeks
Scheduled monitoring and final resting-state EEG recording with stimulator on before discharge.
Approximately 6 post-operative visits
Total: 3 locations
1
Federal Autonomous Educational Institution of Higher Education FEFU
Vladivostok, Primorskiy (Maritime) Kray, Russia, 690922
Actively Recruiting
2
Federal Center of Brain Research and Neurotechnologies
Moscow, Russia, 117513
Actively Recruiting
3
Vladimir Zelman Center for Neurobiology and Brain Rehabilitation, Skolkovo Institute of Science and Technology
Moscow, Russia, 121205
Active, Not Recruiting
A
Artur Biktimirov, MD
D
Daria Kleeva, Research Fellow
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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