Verticality PerceptionNCT02184130
Altered Vestibular Perception and Transcranial Magnetic Stimulation
A study testing transcranial magnetic stimulation and motion stimuli in people with Verticality Perception and Self-motion Perception, run by University of Zurich at 1 site in Switzerland.
Trial summary
The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences motion sensation. Patients with vestibular disorders frequently have disabling disturbances of perception. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Verticality Perception, Self-motion Perception
- What is being tested?
- transcranial magnetic stimulation and motion stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-70
- informed consent
Who cannot join
- disturbed consciousness
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- prior history of a major psychiatric disorder
- history of definite stroke
- focal lesion on MRI exam
- use of anxiolytic, antidepressant, neuroleptic or sedative medication
Show all 11Show fewer
- has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
- History of seizure or a family history of epilepsy;
- increased intracranial pressure, such as after infarctions or trauma
- pregnancy or possibility of being pregnant unless precluded by a negative pregnancy test
- history of any significant head trauma.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Altered Vestibular Perception by Virtual Lesions of Cerebral and Cerebellar Structures Using Repetitive Transcranial Magnetic Stimulation - Implications for Human Vestibular Dysfunction
The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences motion sensation. Patients with vestibular disorders frequently have disabling disturbances of perception. Related to these symptoms is that large areas of the cerebral hemispheres and the cerebellum receive information from the vestibular, visual and somatosensory systems that is integrated within a vestibular cortical network into an accurate perception of spatial orientation. Interrupting the pathways that process information about the direction of gravity and angular velocity leads to impairment of the internal estimate of gravity and the perception of body motion. The strategy of this research is to use repetitive transcranial magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss of function within the central vestibular pathways at the very beginning of adaptation. Our underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to affect ocular motor control of vestibular reflexes and perception alike but with a cortical lesion there will be dissociation between ocular motor control and perception. This research helps to understand the mechanisms involved in the perception of vestibular information and the cerebellar influence on processing vestibular input and offers a unique opportunity to make major inroads into the understanding and eventually treatment of the often incapacitating symptoms of patients with vestibular disease
- Conditions
- Verticality Perception, Self-motion Perception
- Being tested
- transcranial magnetic stimulation and motion stimuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulation and motion stimuliOther
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Not described Receives: Other: transcranial magnetic stimulation and motion stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in verticality perception and self-motion perception after TMS (transcranial magnetic stimulation)
Measured: within 30min after TMS
Secondary outcomes (1)
vestibulo-ocular reflex after TMS (transcranial magnetic stimulation)
Measured: within 30min after TMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startOct 2011
- Primary completionNov 2016
- Study completionSep 2017
Why it stopped: insufficient funds and participants, thus terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verticality PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Straumann, Prof MD, Principal investigator, University Hospital Zurich, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184130
- Sponsor's protocol ID
- tms_percept_zurich
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Vestibular Perception by Virtual Lesions of Cerebral and Cerebellar Structures Using Repetitive Transcranial Magnetic Stimulation - Implications for Human Vestibular Dysfunction
- ClinicalTrials.gov ID
- NCT02184130
- Acronym / sponsor ID
- tms_percept_zurich
- Conditions
- Verticality Perception, Self-motion Perception
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient funds and participants, thus terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences motion sensation. Patients with vestibular disorders frequently have disabling disturbances of perception. Related to these symptoms is that large areas of the cerebral hemispheres and the cerebellum receive information from the vestibular, visual and somatosensory systems that is integrated within a vestibular cortical network into an accurate perception of spatial orientation. Interrupting the pathways that process information about the direction of gravity and angular velocity leads to impairment of the internal estimate of gravity and the perception of body motion. The strategy of this research is to use repetitive transcranial magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss of function within the central vestibular pathways at the very beginning of adaptation. Our underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to affect ocular motor control of vestibular reflexes and perception alike but with a cortical lesion there will be dissociation between ocular motor control and perception. This research helps to understand the mechanisms involved in the perception of vestibular information and the cerebellar influence on processing vestibular input and offers a unique opportunity to make major inroads into the understanding and eventually treatment of the often incapacitating symptoms of patients with vestibular disease
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Other: transcranial magnetic stimulation and motion stimuli |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ages 18-70
- informed consent
Key exclusion criteria (11 listed)
- disturbed consciousness
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- prior history of a major psychiatric disorder
- history of definite stroke
- focal lesion on MRI exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulation and motion stimuli | Other | TMS |
Primary outcome
changes in verticality perception and self-motion perception after TMS (transcranial magnetic stimulation)
Time frame: within 30min after TMS
1 secondary outcome
vestibulo-ocular reflex after TMS (transcranial magnetic stimulation)
Time frame: within 30min after TMS
Results and safety
The study was stopped early (reason given: insufficient funds and participants, thus terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Straumann, Prof MD principal investigator
University Hospital Zurich, Division of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation and motion stimuli in people with Verticality Perception and Self-motion Perception, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient funds and participants, thus terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in verticality perception and self-motion perception after TMS (transcranial magnetic stimulation) (time frame: within 30min after TMS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.