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

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

Interventions

DEVICE

Low Intensity Transcranial Magnetic Stimulation

* 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.

DEVICE

Auditory and visual stimulation

* 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.

Sponsors & Collaborators

• Novosibirsk State Medical University

  collaborator OTHER

• Siberian Scientific Research and Test Center for Biomedical Engineering

  lead OTHER

Principal Investigators

• Viktor Drobyshev, Dr. Med. Sc. · Novosibirsk State Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-16

Primary Completion

2024-12-15

Completion

2025-02-28

Countries

• Russia

Study Locations