Measuring Vestibular Organ Function With Weak Alternating Current Stimulation

NCT ID: NCT07267910

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Vestibular Disorder Vestibular Schwannoma Vestibular Neuritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All study participants will get the same interventions but in different randomized order. The order randomization is based on the balanced Latin square design such that each intervention type occurs equally often in each position in the order, so that any order effects are distributed evenly among the subjects.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

All study participants will get the same interventions but in different randomized order. The investigator does know the possible types of intervention but not the order they will be applied in. Therefore at the time of applying the intervention neither the participant nor the investigator know which specific intervention is being applied.

Study Groups

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EVS + measurement

The study composes of multiple interventions (1-3 min electrical vestibular stimulation and response measurement). All study participants will get the same interventions but in different randomized order.

Group Type EXPERIMENTAL

Active transcranial electrical vestibular stimulation (Active EVS)

Intervention Type DEVICE

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 stimulation waveforms which are applied in a randomized sequence, such that neither the participant nor the investigator know the exact stimulation type at the time of the measurement.

Sham transcranial electrical vestibular stimulation (Sham EVS)

Intervention Type DEVICE

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.

Control measurement

Intervention Type DEVICE

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.

Interventions

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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 stimulation waveforms which are applied in a randomized sequence, such that neither the participant nor the investigator know the exact stimulation type at the time of the measurement.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Business Finland

OTHER

Sponsor Role collaborator

Aalto University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilkka Laakso, D.Sc. (Tech)

Role: PRINCIPAL_INVESTIGATOR

Aalto University

Topi Jutila, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HUS Helsinki University Hospital

Locations

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Dept. of Otorhinolaryngology, HUS Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Central Contacts

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Janita Nissi, D.Sc. (Tech)

Role: CONTACT

+358 504344819

Otto Kangasmaa, M.Sc. (Tech)

Role: CONTACT

+358 503443152

Facility Contacts

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Topi Jutila, MD, PhD

Role: primary

+358 504271558

Other Identifiers

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VESTI

Identifier Type: -

Identifier Source: org_study_id

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