Measuring Vestibular Organ Function With Weak Alternating Current Stimulation

NCT07267910 | Not Yet Recruiting

• 1 other identifier: VESTI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Vestibular Disorder; Vestibular Schwannoma; Vestibular Neuritis

Keywords

Vestibular disorders; Otorhinolaryngologic Diseases; Electrical vestibular stimulation; transcranial electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in the frequency content of the movement response signals

  Changes of the power in a frequency band of 0-20 Hz in the measured movement response signals during active electrical vestibular stimulation (EVS). The measured movement response signals are force plate Center of Pressure (CoP) and 3-axis acceleration data from wearable acceleration sensors.

  From study appointment to the analysis of the results (up to 12 months)

Secondary Outcomes (2)

• Latency of the EVS response

  From study appointment to the analysis of the results (up to 12 months)

• Highest frequency of the EVS-induced response

  From study appointment to the analysis of the results (up to 12 months)

Study Arms (1)

EVS + measurement

EXPERIMENTAL

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.

Device: Active transcranial electrical vestibular stimulation (Active EVS); Device: Sham transcranial electrical vestibular stimulation (Sham EVS); Device: Control measurement

Interventions

Active transcranial electrical vestibular stimulation (Active EVS) 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.

EVS + measurement

Sham transcranial electrical vestibular stimulation (Sham EVS) 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.

EVS + measurement

Control measurement 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.

EVS + measurement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalto University: lead
• Helsinki University Central Hospital: collaborator
• Business Finland: collaborator

Study Sites (1)

Dept. of Otorhinolaryngology, HUS Helsinki University Hospital

Helsinki, 00130, Finland

Location

MeSH Terms

Conditions

Vestibular Diseases; Neuroma, Acoustic; Vestibular Neuronitis; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Ilkka Laakso, D.Sc. (Tech)

  Aalto University

  PRINCIPAL INVESTIGATOR

• Topi Jutila, MD, PhD

  HUS Helsinki University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janita Nissi, D.Sc. (Tech)

CONTACT

+358 504344819; janita.nissi@aalto.fi

Otto Kangasmaa, M.Sc. (Tech)

CONTACT

+358 503443152; otto.kangasmaa@aalto.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)