An interventional study of Low Intensity Transcranial Magnetic Stimulation and Auditory and visual stimulation in Recovery Methods, Rehabilitation Program and Stroke, Ischemic, sponsored by Siberian Scientific Research and Test Center for Biomedical Engineering. Enrolling by invitation at 1 site in Russian Federation. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Siberian Scientific Research and Test Center for Biomedical Engineering · Not applicable, Interventional, and Treatment
This randomized, controlled, single-blind clinical pilot study investigates the therapeutic potential of low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) and newly offered interventional protocols in healthy participants for further research on stroke rehabilitation and therapeutic effects.
The goal of this clinical trial is to learn if the intervention can be used in the future treatment of patients recovering after stroke. It will also learn about the safety of low-intensity repetitive transcranial magnetic stimulation and audio-visual stimulation.
The main questions it aims to answer are:
Does intervention with LI-TMS and AVS influence the parameter Work Efficiency (WE) of the participant? Does intervention with LI-TMS and AVS influence the parameter Warming-up work indicator (WU) of the participant? Does intervention with LI-TMS and AVS influence the parameter Psychological Stability (PS) of the participant? Does intervention with LI-TMS and AVS influence the parameter Perceptual Accuracy (Tv) of the participant? Does intervention with LI-TMS and AVS affect changes in the participants electroencephalogram parameters? The researchers will compare the results of LI-TMS and AVS intervention to a control group that received no intervention but only underwent an examination to evaluate the effects of the interventions.
Participants will:
Receive interventions from LI-TMS and AVS every day for 2 weeks with a weekend break on Saturday and Sunday.
Attend the clinic 3 times during the trial and undergo testing and screening. The first clinic visit is before the intervention course. The second clinic visit will be the day immediately following the end of the two-week intervention course. The third visit will be two weeks after the second visit.
Stroke is a leading cause of disability worldwide, significantly impacting individuals; quality of life and their ability to perform daily activities. Rehabilitation is critical for stroke survivors as it aims to restore function, improve mobility, and enhance overall well-being.
Auditory-visual stimulation (AVS) is a stroke rehabilitation technique that combines auditory and visual stimuli to promote cognitive and motor recovery. This approach is based on the principles of neuroplasticity, which suggest that engaging multiple senses through receptor systems can promote brain plasticity and recovery after neurological injury such as stroke.
Transcranial Magnetic Stimulation (TMS) is a promising technique in stroke rehabilitation that involves applying magnetic fields to the scalp, which induces electrical currents in specific brain regions. This method is believed to facilitate neuroplasticity, the brains ability to reorganize itself by forming new neural connections.
LI-TMS is a variant of TMS that uses lower intensity magnetic fields. This technique is designed to minimize discomfort while still promoting neuroplasticity. Key aspects of LI-TMS include:
This study aims to test the proposed interventional protocols using a prototype device for low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) on healthy participants.
Participants in the experimental group are screened and tested upon their first visit to the hospital. Afterward, intervention courses are run five days a week for two weeks. Activities take place on Monday, Tuesday, Wednesday, Thursday and Friday while Saturday and Sunday are free. Interventions of each protocol are applied for two days in routine. At the end of the intervention course, participants are screened and tested again at the hospital and after two weeks.
The following is how the Interventional procedure goes: first, the device will be plugged in and tested, then in 5 minutes the subject sits in a comfortable chair, further a disposable hair cap is put on his/her head, a textile helmet with coil emitters is put on top of the disposable hair cap, then glasses with Red, Green, Blue Light-emitting diodes and stereo headphones. The Interventional protocol was selected in prototype software. In conformance with the selected Interventional protocol, the characteristics of the exposure signal were then set up. The button on the prototypes touch screen was pressed next. The intervention procedure was stopped when the time on the timer on the touch screen of the prototype expired. When the exposure procedure was over, the prototype was switched off and all its exposure units were taken off of the test subject in reverse order.
The study will involve two groups: an experimental group and a control group. The experimental group, consisting of 30 healthy participants, will receive a course of interventions over two weeks of days. The comparison will be made with a control group consisting of 10 healthy participants who will receive no intervention, only screening, and testing.
Interventions. Experimental: Day 1 and Day 2
Control: Day 1 - Day 14 The control group does not receive any intervention for 14 days.
Participants in the experimental group and control group are screened and tested on the first day and on day fourteen and on day 28th of the study.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Siberian Scientific Research and Test Center for Biomedical Engineering as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants must be in good general health, as verified by reviewing their medical history and physical examination. They must not have any serious illnesses that could be a barrier to the research.
Exclusion Criteria:
Participants receive low-intensity transcranial magnetic stimulation interventions with audio-visual stimulation for 14 days. On days 6, 7, 13, and 14 of the study, participants will not receive any interventions. Participants will be screened and tested on days 1 and 14 of treatment and two weeks after the end of the intervention.
Device: Low Intensity Transcranial Magnetic Stimulation · Device: Auditory and visual stimulation
Participants receive no interventions for 14 days. Participants will be screened and tested on days 1, 14 and 28.
* Magnetic stimulation frequency range: 0.1 - 700 Hz. * Amplitude of the magnetic field at a short distance from the magnetic coil: 1-5 milliTesla. * Emitter coil dimensions: ⌀28×26 mm. * Number of emitter coils: 32 coils. * Covering the entire scalp of a human head with 32 coil emitters.
Also known as: LI-TMS
* Frequency range of light stimulation: 0.1 - 60 Hz. * Audio stimulation frequency range: 20 - 2000 Hz. * Sound level: 70 Decibel. * The wavelength range of visual stimulation: red - 620 - 760 nm; green - 510 - 550 nm; blue - 450 - 480 nm. * Illuminance: 300 - 350 lx.
Work Efficiency (WE)
Work Efficiency (WE) is a key parameter derived from the Schulte table test that quantifies the effectiveness of a participants performance during the test. It reflects the relationship between the number of correct responses and the time taken to complete the task. Calculation of Work Efficiency is calculated using the following formula: WE= T/N. Where: N = the number of tables completed by the participant. T = Time taken to complete the test (measured in seconds). This formula indicates that Work Efficiency increases with either a higher number of correct responses or a shorter completion time. Measurement Units Values in the range of 30 to 50 seconds are good result. Values above 90 seconds are a negative result. Better result of WE suggest better cognitive efficiency and processing speed, while worse result may indicate difficulties in attention or visual processing.
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Warming-up Work Indicator (WU)
Warming-up Work Indicator (WU) indicates the amount of effort or cognitive load that an individual expends during the initial phase of the test. Calculation of WU The WU is typically calculated based on the time taken to complete the first task of the Schulte table test compared to the overall time taken for the entire test. The first tasks time is compared with the average WE time. A WU ratio close to 1 indicates the best possible preparation of the participant, whereas ratios above 1 indicate that more time needs to be taken as a warm-up before optimal performance. WU = T1 / WE Measurement Units A result less than 1.0 is an indicator of good Warming-up Work Indicator; accordingly, the higher 1.0 this indicator is, the more the subject needs preparation for the main job.
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Psychological Stability (PS)
Psychological Stability (PS) is a parameter derived from the Schulte table test that assesses the ability to sustain the operational activity for a long time. It reflects how well a participant can manage distractions and maintain attention throughout the test. Calculation: PS =T(n-1) /WE. Measurement Units. Psychological Stability does not have a standardized unit of measurement; rather, it is often expressed as a score or index that can be compared across individuals or populations. Measurement Units The result indicator less than 1.0 indicates good Psychological Stability, accordingly, the higher this indicator is, the worse the Psychological Stability of the test subject to perform the tasks.
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Attention switching time (t)
The Test of Attention Switching Time Using Black-Red Table is a psychological assessment designed to measure the efficiency of attention switching in individuals. Attention switching time (t) refers to the duration it takes for an individual to shift their focus from one task or stimulus to another. It is a critical parameter in cognitive psychology, as it reflects the efficiency of an individuals cognitive processing and ability to manage attention in dynamic environments. Calculation: The difference between the time required to complete the last task and the sum of the time spent working on the first and the second task will be the time the subject spends switching attention from one activity to another. Measurement Units A shorter completion time of the Attentional Switching Time Test using the Black-Red Tables indicates better attentional switching ability.
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Perceptual Accuracy (Tv)
The Memorize and Place Shapes task is a cognitive assessment designed to evaluate spatial memory and perceptual accuracy. Perceptual Accuracy (Tv) refers to the precision with which an individual can recognize and reproduce shapes after they have been memorized. This parameter is crucial in understanding cognitive functions related to memory and visual processing. Calculation: The result is an overall calculation made from the complete number of dots correctly placed on all forms. Among others, the following is calculated: Perceptual accuracy: Tv = (∑ / n) \* 100, where ∑ is the total number of correctly filled-in Remember and dot test forms and n is the number of dot cards viewed. Multiply the result of the division by 100 to obtain the perceptual accuracy in percent. Measurement Units The higher the Perceptual Accuracy (Tv) score on the Memorise and Place Shapes test, the better the participant\'s visual perception.
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
EEG
Standard procedure for recording an electroencephalogram.
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Plan to share: Yes — All individual patient data that underline results in a publication will be shared.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.