MigraineNCT04196933
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
A study testing Temporal Binding Adaptation - PSS training, Temporal Binding Adaptation - PSS adaptation with VI stimulation and Chronic Motion-modulated Stimulation in people with Migraine and Vestibular Migraine, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. Read more about this study
- Who is it for?
- Ages 8 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Vestibular Migraine, Vestibular Schwannoma
- What is being tested?
- Temporal Binding Adaptation - PSS training, Temporal Binding Adaptation - PSS adaptation with VI stimulation and Chronic Motion-modulated Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 31 Dec 2025
- 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 8 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal subjects
- normal vestibular-oculomotor exams
- normal low-frequency standard rotational testing
- normal hearing
- Migraine
- meets International Headache Society (IHS) criteria for migraine with or without aura
Show all 23Show fewer
- tested more than 2 weeks after most recent migraine headache
- Vestibular Migraine
- meets Barany Society criteria for vestibular migraine, which includes:
- episodic vestibular symptoms that occur with headaches that meet the IHS criteria for migraine
- tested more than 2 weeks after most recent migraine headache or vestibular episode
- Vestibular Schwannoma
- existence of unilateral vestibular schwannoma (pre \& post clinical intervention e.g. surgical resection)
- must plan to have clinical intervention such as sub-occipital surgical approach with complete sectioning of the vestibular nerve
- rotational testing to assess pre-surgical vestibular function
- audiogram
- brain MRI consistent with vestibular schwannoma
- audiography in each ear
- Vestibular (VI) and Cochlear (CI) Implant subjects
- scheduled for CI surgery because of deafness
- minimum 5 year history of documented absence of auditory and vestibular function, based on review of their audiograms and vestibular tests
- specific vestibular criteria: peak ice water caloric response of less than 3deg/s for each ear; yaw VOR time constant <3s and gain <0.25; and reduced head impulse gain (<0.25) for all canal planes
- specific audiographic criteria: 80dB or greater sensorineural hearing loss in both ears
Who cannot join
- Normal subjects
- history of otologic or neurologic disease
- on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- pregnant or recently (<6mos) pregnant
- Migraine
- history of vestibular symptoms (other than motion sickness)
Show all 16Show fewer
- evidence of other neurologic or otologic dysfunction
- on migraine prophylactic medications
- on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- Vestibular Migraine (VM)
- other neurologic or otologic dysfunction as defined above except for central eye movement findings that are consistent with VM and therefore not exclusionary.
- on migraine prophylactic medication
- on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- Vestibular Schwannoma
- other otologic disease (other than presbycusis) or any neurologic disease (other than migraine)
- on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: Temporal Synthesis of Vestibular and Extra-Vestibular Sensory Signals
Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. The temporal binding of vestibular and non-vestibular sensory cues is poorly understood and has not been studied in detail, despite the fact that the vestibular system operates in an inherently multimodal environment. In this study, the researchers are investigating the physiology and pathophysiology of vestibular temporal binding by studying normal subjects, patients with peripheral and central vestibular dysfunction, and patients with vestibular and cochlear signals provided by prosthetic implants in the inner ear.
Read the detailed description
Multiple sensory cues are generated by discrete events (e.g., the vestibular-visual signals after hitting a pothole) and while they do not reach the cerebrum simultaneously, the brain can synthesize them if they are interpreted as corresponding to a single event. This is critical because the central representation of an event is improved if two or more relevant cues are integrated but conversely is degraded if unrelated inputs are synthesized. Little research has focused on temporal binding of vestibular signals with other sensory cues, even though the vestibular system operates in an inherently multimodal environment, and virtually nothing is known about temporal binding abnormalities in patients with peripheral or central vestibular disorders. The investigators will use psychophysical tests (quantifying the PSS [point of subjective simultaneity] and TBW [temporal binding window]) to study vestibular temporal binding in normal people, patients with combined vestibular and cochlear prostheses, and patients with peripheral or central vestibular dysfunction. The researchers will investigate two fundamental aspects of temporal binding: its dependence on signal precision and adaptation driven by habitual exposure to sensory patterns. Furthermore, the researchers will investigate how and why temporal binding differs from normal in patients with peripheral and central vestibular dysfunction.
- Conditions
- Migraine, Vestibular Migraine, Vestibular Schwannoma, Motion Sickness, Dizziness, Vestibular Disorder
- Being tested
- Temporal Binding Adaptation - PSS training, Temporal Binding Adaptation - PSS adaptation with VI stimulation, Chronic Motion-modulated Stimulation
- Keywords
- sensory integration, cochlear implant, vestibular implant, balance, dizziness, vestibular disorders
- Medical subject headings
- Migraine Disorders, Neuroma, Acoustic, Motion Sickness, Dizziness, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Binding Adaptation - PSS trainingBehavioural
After the PSS and TBW are calculated with the standard TOJ paradigm, 100 training trials are provided where the SOA is set to a PSS slightly greater than what was the mean calculated for normal subjects, with the goal of shifting the PSS in a direction associated with better clinical vestibular parameters and vestibular precision measurements (e.g. standard rotational testing VOR time constant, lower DHI, higher FGA score) . Then the TOJ task will be repeated but every 10 testing trials will be followed by 10 training trials (SOA = PSS desired or mean normal PSS), and this pattern will be repeated 10 times to 100 more training trials interspersed with the Post TOJ data. Subjects will respond after all trials and testing and training will not be distinguished. After this is completed, the new PSS and TBW are calculated. Sham PSS training will be identical to the above except that the 'training' period will consist of random SOAs rather than a series of fixed SOAs.
Temporal Binding Adaptation - PSS adaptation with VI stimulationBehavioural
The adaptation will utilize the same approach used in non-implanted patients. The investigators will provide a repeated, fixed SOA with either the CI or VI leading the other stimulus by 220 ms. After the training period, which will match the number of stimuli pairs provided to our normal vestibular-auditory control subjects undergoing PSS adaptation, the TOJ study is repeated to recalculate the PSS and TBW.
Chronic Motion-modulated StimulationBehavioural
To provide 8 hours of 'physiologic' CI and VI inputs during normal activities, the investigators will employ standard motion-modulated stimulation with the VI. This requires pre-adaptation to a 200 pps tonic stimulation rate (to emulate the push-pull design of the native vestibular system allowing modulating stimulation upward or downward with opposite directions of motion). The three electrodes are connected to the head-mounted prosthetic circuit, which consists of three angular velocity sensors (one aligned with the sensitive axis of each canal) such that head rotations in the plane of the given canal modulate the stimulation rate of the corresponding electrode, upward (for ipsi) or downward (for contralateral) head rotations, thereby simulating normal canal-mediated modulations.
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | No intervention | normal control subjects - no history of neurologic or inner ear disease The investigators will characterize vestibular spatial and temporal precision by calculating perceptual thresholds for vestibular (yaw rotation) stimuli in normal subjects over a wide age range. Vestibular-visual temporal binding is then performed on each subject and the relationship between the principal parameters (vestibular perceptual thresholds [inversely related to spatial precision] and the PSS and TBW from the temporal binding paradigm) will be examined. The investigators will collect qualitative assessments of dizziness/disbalance (DHI: dizziness handicap index) and quantitative measurements of balance and vestibular function (FGA: functional gait analysis, postural sway, and standard rotational testing - VOR gain, time constant, asymmetry). |
| Central Vestibular Dysfunction | No intervention | Migraine and Vestibular Migraine patients The investigators intend to evaluate vestibular (yaw rotation) - visual temporal binding in people with a wide range of motion sickness sensitivities (as quantified with standard questionnaires), including normal subjects, people with migraine and with vestibular migraine. |
| Peripheral Vestibular Dysfunction | No intervention | Vestibular Schwannoma patients The basic approach is to characterize the precision of their vestibular information (i.e., perceptual thresholds for spatial precision), and their temporal binding characteristics for vestibular (yaw rotation)-visual inputs, in three states: pre-op, sub-acute post-op (2-6 weeks), and chronic post-op (6 months+). At each state the investigators will also assess the quality of their vestibular-mediated behaviors through questionnaires (e.g. DHI), postural sway, functional gait analysis, and standard rotational testing (VOR gain, time constant, and asymmetry). |
| Implant Subjects | Experimental | Cochlear Implant (CI)/Vestibular Implant (VI) patients
A causative role for vestibular precision in temporal binding will be investigated in the VI patients, since the noise characteristics of the vestibular channel will be varied and to determine how this affects thresholds and temporal binding. As part of a second aim, the investigators will use VI and CI prosthetic signals in patients who have never received them together to see how the brain process sensory cues to which it is essentially naïve. Finally, after the acute experiments the investigators will provide 8 hours of 'physiologic' VI and CI stimulation by turning both implants on, sound modulates activity in the CI as usual, and angular head motion modulates activity in the VI while the subject actively explores the hospital environment. Receives: Behavioral: Temporal Binding Adaptation - PSS adaptation with VI stimulation; Behavioral: Chronic Motion-modulated Stimulation |
| Post-op Vestibular Schwannoma patients | Experimental | Vestibular Schwannoma patients who are 6mos+ post-surgery (for removal of vestibular schwannoma, resulting in 8th nerve being cut \& complete loss of peripheral vestibular signals from affected ear). While many post-op VS patients recover well, some continue to have persistent problems with balance and symptoms of dizziness. This study will explore how/whether PSS adaptation may improve vestibular clinical outcomes such as improved gait and dizziness symptoms following gait with horizontal (yaw) head motion. Receives: Behavioral: Temporal Binding Adaptation - PSS training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postural sway/balance
Measurements of postural sway during Romberg testing on floor and foam (including an extra 60s balance test during which subject stands on foam and shakes head left and right at 1hz frequency while fixating on a point a set distance away) pre \& post temporal binding adaptation (TBW \& PSS training).
Measured: baseline and post-PSS adaptation (1 hour)
Change in rapid measure of gait
This measure is scored before and after PSS adaptation in UVD (unilateral vestibular dysfunction) patients. Gait is scored by performance on a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.
Measured: baseline and post-PSS adaptation (1 hour)
Change in measure of inducible dizziness
Looking at the change between before and after PSS adaptation in UVD (unilateral vestibular dysfunction) patients. Inducible dizziness is the symptom severity provoked by a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.
Measured: baseline and post-PSS adaptation (1 hour)
Change in Point of Subjective Simultaneity (PSS)
Pre and post chronic motion-modulated stimulation in CI/VI patients - the PSS will be measured during temporal binding testing
Measured: baseline and 1 hour post 8-hour VI-CI 'physiologic' stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start5 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Following further collection and analysis of temporal binding data, we found the relationship between PSS and clinical outcomes to not be strong enough for adaptation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Oregon Health and Science University, University of Geneva, Switzerland
- Responsible party
- Principal investigator, Richard Lewis, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196933
- Sponsor's protocol ID
- 2018P003117
- Other IDs
- 1R01DC017425-01
- Status last verified
- Jun 2024
- First submitted
- 6 Dec 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Synthesis of Vestibular and Extra-Vestibular Sensory Signals
- ClinicalTrials.gov ID
- NCT04196933
- Acronym / sponsor ID
- 2018P003117
- Conditions
- Migraine, Vestibular Migraine, Vestibular Schwannoma, Motion Sickness, Dizziness, Vestibular Disorder
- Keywords
- sensory integration, cochlear implant, vestibular implant, balance, dizziness, vestibular disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Following further collection and analysis of temporal binding data, we found the relationship between PSS and clinical outcomes to not be strong enough for adaptation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Oregon Health and Science University, University of Geneva, Switzerland
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Dec 2019 (actual)
- 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.
Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. The temporal binding of vestibular and non-vestibular sensory cues is poorly understood and has not been studied in detail, despite the fact that the vestibular system operates in an inherently multimodal environment. In this study, the researchers are investigating the physiology and pathophysiology of vestibular temporal binding by studying normal subjects, patients with peripheral and central vestibular dysfunction, and patients with vestibular and cochlear signals provided by prosthetic implants in the inner ear.
Detailed description
Multiple sensory cues are generated by discrete events (e.g., the vestibular-visual signals after hitting a pothole) and while they do not reach the cerebrum simultaneously, the brain can synthesize them if they are interpreted as corresponding to a single event. This is critical because the central representation of an event is improved if two or more relevant cues are integrated but conversely is degraded if unrelated inputs are synthesized. Little research has focused on temporal binding of vestibular signals with other sensory cues, even though the vestibular system operates in an inherently multimodal environment, and virtually nothing is known about temporal binding abnormalities in patients with peripheral or central vestibular disorders. The investigators will use psychophysical tests (quantifying the PSS [point of subjective simultaneity] and TBW [temporal binding window]) to study vestibular temporal binding in normal people, patients with combined vestibular and cochlear prostheses, and patients with peripheral or central vestibular dysfunction. The researchers will investigate two fundamental aspects of temporal binding: its dependence on signal precision and adaptation driven by habitual exposure to sensory patterns. Furthermore, the researchers will investigate how and why temporal binding differs from normal in patients with peripheral and central vestibular dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | No intervention | –normal control subjects - no history of neurologic or inner ear disease The investigators will characterize vestibular spatial and temporal precision by calculating perceptual thresholds for vestibular (yaw rotation) stimuli in normal subjects over a wide age range. Vestibular-visual temporal binding is then performed on each subject and the relationship between the principal parameters (vestibular perceptual thresholds [inversely related to spatial precision] and the PSS and TBW from the temporal binding paradigm) will be examined. The investigators will collect qualitative assessments of dizziness/disbalance (DHI: dizziness handicap index) and quantitative measurements of balance and vestibular function (FGA: functional gait analysis, postural sway, and standard rotational testing - VOR gain, time constant, asymmetry). |
| Central Vestibular Dysfunction | No intervention | –Migraine and Vestibular Migraine patients The investigators intend to evaluate vestibular (yaw rotation) - visual temporal binding in people with a wide range of motion sickness sensitivities (as quantified with standard questionnaires), including normal subjects, people with migraine and with vestibular migraine. |
| Peripheral Vestibular Dysfunction | No intervention | –Vestibular Schwannoma patients The basic approach is to characterize the precision of their vestibular information (i.e., perceptual thresholds for spatial precision), and their temporal binding characteristics for vestibular (yaw rotation)-visual inputs, in three states: pre-op, sub-acute post-op (2-6 weeks), and chronic post-op (6 months+). At each state the investigators will also assess the quality of their vestibular-mediated behaviors through questionnaires (e.g. DHI), postural sway, functional gait analysis, and standard rotational testing (VOR gain, time constant, and asymmetry). |
| Implant Subjects | Experimental | Behavioral: Temporal Binding Adaptation - PSS adaptation with VI stimulation, Behavioral: Chronic Motion-modulated StimulationCochlear Implant (CI)/Vestibular Implant (VI) patients A causative role for vestibular precision in temporal binding will be investigated in the VI patients, since the noise characteristics of the vestibular channel will be varied and to determine how this affects thresholds and temporal binding. As part of a second aim, the investigators will use VI and CI prosthetic signals in patients who have never received them together to see how the brain process sensory cues to which it is essentially naïve. Finally, after the acute experiments the investigators will provide 8 hours of 'physiologic' VI and CI stimulation by turning both implants on, sound modulates activity in the CI as usual, and angular head motion modulates activity in the VI while the subject actively explores the hospital environment. |
| Post-op Vestibular Schwannoma patients | Experimental | Behavioral: Temporal Binding Adaptation - PSS trainingVestibular Schwannoma patients who are 6mos+ post-surgery (for removal of vestibular schwannoma, resulting in 8th nerve being cut \& complete loss of peripheral vestibular signals from affected ear). While many post-op VS patients recover well, some continue to have persistent problems with balance and symptoms of dizziness. This study will explore how/whether PSS adaptation may improve vestibular clinical outcomes such as improved gait and dizziness symptoms following gait with horizontal (yaw) head motion. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Normal subjects
- normal vestibular-oculomotor exams
- normal low-frequency standard rotational testing
- normal hearing
- Migraine
Key exclusion criteria (16 listed)
- Normal subjects
- history of otologic or neurologic disease
- on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- pregnant or recently (<6mos) pregnant
- Migraine
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 |
|---|---|---|
| Temporal Binding Adaptation - PSS trainingAfter the PSS and TBW are calculated with the standard TOJ paradigm, 100 training trials are provided where the SOA is set to a PSS slightly greater than what was the mean calculated for normal subjects, with the goal of shifting the PSS in a direction associated with better clinical vestibular parameters and vestibular precision measurements (e.g. standard rotational testing VOR time constant, lower DHI, higher FGA score) . Then the TOJ task will be repeated but every 10 testing trials will be followed by 10 training trials (SOA = PSS desired or mean normal PSS), and this pattern will be repeated 10 times to 100 more training trials interspersed with the Post TOJ data. Subjects will respond after all trials and testing and training will not be distinguished. After this is completed, the new PSS and TBW are calculated. Sham PSS training will be identical to the above except that the 'training' period will consist of random SOAs rather than a series of fixed SOAs. | Behavioural | Post-op Vestibular Schwannoma patients |
| Temporal Binding Adaptation - PSS adaptation with VI stimulationThe adaptation will utilize the same approach used in non-implanted patients. The investigators will provide a repeated, fixed SOA with either the CI or VI leading the other stimulus by 220 ms. After the training period, which will match the number of stimuli pairs provided to our normal vestibular-auditory control subjects undergoing PSS adaptation, the TOJ study is repeated to recalculate the PSS and TBW. | Behavioural | Implant Subjects |
| Chronic Motion-modulated StimulationTo provide 8 hours of 'physiologic' CI and VI inputs during normal activities, the investigators will employ standard motion-modulated stimulation with the VI. This requires pre-adaptation to a 200 pps tonic stimulation rate (to emulate the push-pull design of the native vestibular system allowing modulating stimulation upward or downward with opposite directions of motion). The three electrodes are connected to the head-mounted prosthetic circuit, which consists of three angular velocity sensors (one aligned with the sensitive axis of each canal) such that head rotations in the plane of the given canal modulate the stimulation rate of the corresponding electrode, upward (for ipsi) or downward (for contralateral) head rotations, thereby simulating normal canal-mediated modulations. | Behavioural | Implant Subjects |
Primary outcome
Changes in postural sway/balance
Time frame: baseline and post-PSS adaptation (1 hour)
Measurements of postural sway during Romberg testing on floor and foam (including an extra 60s balance test during which subject stands on foam and shakes head left and right at 1hz frequency while fixating on a point a set distance away) pre \& post temporal binding adaptation (TBW \& PSS training).
Change in rapid measure of gait
Time frame: baseline and post-PSS adaptation (1 hour)
This measure is scored before and after PSS adaptation in UVD (unilateral vestibular dysfunction) patients. Gait is scored by performance on a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.
Change in measure of inducible dizziness
Time frame: baseline and post-PSS adaptation (1 hour)
Looking at the change between before and after PSS adaptation in UVD (unilateral vestibular dysfunction) patients. Inducible dizziness is the symptom severity provoked by a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.
Change in Point of Subjective Simultaneity (PSS)
Time frame: baseline and 1 hour post 8-hour VI-CI 'physiologic' stimulation
Pre and post chronic motion-modulated stimulation in CI/VI patients - the PSS will be measured during temporal binding testing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Binding Adaptation - PSS training, Temporal Binding Adaptation - PSS adaptation with VI stimulation and Chronic Motion-modulated Stimulation in people with Migraine and Vestibular Migraine, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
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 23 inclusion and 16 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: withdrawn, as of the sponsor's last update on 16 Apr 2025. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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 postural sway/balance (time frame: baseline and post-PSS adaptation (1 hour)). The study lists 4 primary outcomes in all. 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 16 Apr 2025.