Dept. of Otorhinolaryngology, HUS Helsinki University Hospital
Helsinki, 00130, Finland
NCT Number: NCT07267910
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?
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Helsinki, 00130, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (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.
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.
Time frame: From study appointment to the analysis of the results (up to 12 months)
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.
Time frame: From study appointment to the analysis of the results (up to 12 months)
Latency of the EVS-induced movement response measured as the time delay between the stimulation and the measured movement.
Time frame: From study appointment to the analysis of the results (up to 12 months)
Highest frequency at which EVS induces a response determined via spectral analysis of the movement data
Aalto University
Other
Measuring Vestibular Organ Function With Weak Alternating-current Stimulation
Acronym: VESTI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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