A Randomized, Single-blind Trial of LI-TMS and AVS for Stoke Recovery in Healthy Participants (Phase 1).

NCT06613282 | Enrolling By Invitation

• 1 other identifier: LI-TMS and AVS for recovery
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recovery Methods; Rehabilitation Program; Stroke, Ischemic; Stroke

Keywords

Low Intensity Transcranial Magnetic Stimulation; audio-visual stimulation; AVS; recovery after stroke; stroke rehabilitation; LI-TMS

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.

Secondary Outcomes (1)

• EEG

  Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.

Study Arms (2)

LI-TMS and AVS

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants receive no interventions for 14 days. Participants will be screened and tested on days 1, 14 and 28.

Interventions

Low Intensity Transcranial Magnetic Stimulation DEVICE

* 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

LI-TMS and AVS

Auditory and visual stimulation DEVICE

* 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.

LI-TMS and AVS

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• somatic and neurological diseases in the exacerbation stage;
• presence of epileptic seizures on the EEG;
• cognitive disorders;
• presence of visual and hearing pathologies that prevent the sessions;
• women during pregnancy.

Sponsors & Collaborators

• Siberian Scientific Research and Test Center for Biomedical Engineering: lead
• Novosibirsk State Medical University: collaborator

Study Sites (1)

Novosibirsk State Medical University

Novosibirsk, Novosibirsk Oblast, 630091, Russia

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Photic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Viktor Drobyshev, Dr. Med. Sc.

  Novosibirsk State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medical Sciences, Professor of the Department of Hospital Therapy and Medical Rehabilitation at the Novosibirsk State Medical University, Head of the Physiotherapy Department at City Clinical Hospital No. 2

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 25, 2024
• Study Start: September 16, 2024
• Primary Completion: December 15, 2024
• Study Completion: February 28, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Materials will be made available 6 months after publication of the primary outcomes.
• Access Criteria: Data and study materials relevant to any publication will be posted within six months of publication on this site or another open platform on the Internet which will be accessible to any interested party.

Locations

RU (1)