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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Business Finland | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilkka Laakso, D.Sc. (Tech) | Aalto University | Principal Investigator |
| Topi Jutila, MD, PhD | HUS Helsinki University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Otorhinolaryngology, HUS Helsinki University Hospital | Helsinki | 00130 | Finland |
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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.
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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.
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| 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. |
|
| 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. |
|
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) |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D009464 | Neuroma, Acoustic |
| D020338 | Vestibular Neuronitis |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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