Measuring Vestibular Organ Function With Weak Alternating Current Stimulation

Официальное название

Measuring Vestibular Organ Function With Weak Alternating-current Stimulation

Обзор

The goal of this clinical trial is to preliminarily evaluate the use of electrical stimulation in diagnosing disorders with the vestibular system. The main questions it aims to answer are: * Can electrical vestibular stimulation combined with movement measurement be used to diagnose disorders of the vestibular system? * Can electrical stimulation provide treatment or rehabilitation opportunities for patients suffering from disorders of the vestibular system?

Подробное описание

The participants will each attend one experimental session consisting of multiple short (1-3 min) measurement trials. During a trial the participant's vestibular system is stimulated with a transcranial electrical stimulator device and their movements are recorded with a force plate and acceleration sensors.

The goal of the study is to collect and analyse data from 30 research participants with diagnosed vestibular disorders.

Вмешательства

• Устройство Active transcranial electrical vestibular stimulation (Active EVS)
  Active transcranial electrical vestibular stimulation (EVS) with alternating current (maximum peak current below 2 mA and stimulation frequency 2-20 Hz) applied for 1-3 minutes at a time and for under 20 minutes in total. EVS will be applied either bilaterally (ear to ear) or unilaterally (left ear to neck or right ear to neck). The participants movements during the stimulation are measured with a force plate and wearable acceleration sensors. The study uses multiple types of vestibular stimulat
• Устройство Sham transcranial electrical vestibular stimulation (Sham EVS)
  Sham (no current) transcranial electrical vestibular stimulation applied for 1-3 minutes. The participant's movements during the supposed stimulation are measured with a force plate and wearable acceleration sensors. Neither the participant nor the investigator know at what point of the intervention sequence the sham stimulation is applied.
• Устройство Control measurement
  The participant's movements are measured with a force plate and wearable acceleration sensors for the same time duration (1-3 min) and following the same protocols as in other interventions, but both the participant and the investigator know that no stimulation is being applied. The control measurement will always be completed before all other interventions and is not part of the randomized intervention sequence.

Первичные конечные точки

• Changes in the frequency content of the movement response signals [Срок оценки: From study appointment to the analysis of the results (up to 12 months)]

Вторичные конечные точки (2)

• Latency of the EVS response [Срок оценки: From study appointment to the analysis of the results (up to 12 months)]
• Highest frequency of the EVS-induced response [Срок оценки: From study appointment to the analysis of the results (up to 12 months)]

Критерии участия

Критерии включения

• Signed informed consent form
• One of the following: clinically diagnosed vestibular schwannoma, vestibular neuritis, or simultaneous unilateral hearing loss and vestibular dysfunction.

Критерии исключения

• History of epilepsy or seizures
• Past brain surgery
• Pacemaker, cochlear implant, or other implanted medical device
• Pregnancy
• Skin problems or damaged skin at the site of the stimulation (scalp and neck)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Финляндия · 1 центр

• Dept. of Otorhinolaryngology, HUS Helsinki University Hospital — Helsinki

Идентификаторы

NCT: NCT07267910 · VESTI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗