Measuring Vestibular Organ Function With Weak Alternating Current Stimulation (VESTI)

Measuring Vestibular Organ Function With Weak Alternating-current Stimulation

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Vestibular Schwannoma; Vestibular Disorder; Vestibular Neuritis
• Intervention / Treatment: Device: Active transcranial electrical vestibular stimulation (Active EVS); Device: Sham transcranial electrical vestibular stimulation (Sham EVS); Device: Control measurement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janita Nissi, D.Sc. (Tech); Phone Number: +358 504344819; Email: janita.nissi@aalto.fi
• Study Contact Backup: Name: Otto Kangasmaa, M.Sc. (Tech); Phone Number: +358 503443152; Email: otto.kangasmaa@aalto.fi

Study Locations

• Finland
  • Helsinki, Finland, 00130
    • Dept. of Otorhinolaryngology, HUS Helsinki University Hospital
    • Contact: Topi Jutila, MD, PhD; Phone Number: +358 504271558; Email: topi.jutila@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency of the EVS response	Latency of the EVS-induced movement response measured as the time delay between the stimulation and the measured movement.	From study appointment to the analysis of the results (up to 12 months)
Highest frequency of the EVS-induced response	Highest frequency at which EVS induces a response determined via spectral analysis of the movement data	From study appointment to the analysis of the results (up to 12 months)

Collaborators and Investigators

• Sponsor: Aalto University
• Collaborators: Helsinki University Central Hospital; Business Finland
• Investigators: Principal Investigator: Ilkka Laakso, D.Sc. (Tech), Aalto University; Principal Investigator: Topi Jutila, MD, PhD, HUS Helsinki University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Otorhinolaryngologic Diseases; transcranial electrical stimulation; Vestibular disorders; Electrical vestibular stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Labyrinth Diseases; Vestibular Diseases; Neuroma, Acoustic; Vestibular Neuronitis; Otorhinolaryngologic Diseases
• Other Study ID Numbers: VESTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No