Measuring Vestibular Organ Function With Weak Alternating Current Stimulation

Official title

Measuring Vestibular Organ Function With Weak Alternating-current Stimulation

Overview

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

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.

Interventions

• 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 stimulat
• 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.

Primary outcome measures

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

Secondary outcome measures (2)

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Finland · 1 center

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

Identifiers

NCT: NCT07267910 · VESTI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗