All ConditionsNCT07858214
Measurement of Ocular Microtremor With the iTremor Device in a Diverse US Cohort
An observational study of All Conditions and All, run by Head Diagnostics at 2 sites in United States.
Trial summary
To evaluate the reliability of using the iTremor device to accurately measure Ocular Microtremor (OMT) across a diverse cohort, representative of the US population, with a view to establishing this as a standard measurement tool for OMT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- All Conditions, All
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll 120 US subjects total, 18 years of age and older, reflecting the gender, age and racial diversity of the US population. Health status and history will be documented to reflect an all-comers participant group.
Who may be able to join
- Adults 18 years of age or older.
- Normal or corrected to normal bilateral vision.
- Ability to sit and look forward for periods of at least 5 seconds.
- Communicate in English with the study team.
Who cannot join
- Visible or known injuries to eye or eye socket.
- Non-intact periorbital skin
- Oculomotor palsy
- Strabismus (cross-eyedness) / impaired ocular mobility
- Inability to refrain from alcohol, cannabis or other recreational drugs for 24 hours prior to study visit.
- Inability or unwillingness to remove scleral contact lenses or glasses for the length of the study visit.
- Conditions, not explicitly described, identified by clinical exam, which would make achieving a measurement impractical or uncomfortable for the participant.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
To evaluate the reliability of using the iTremor device to accurately measure Ocular Microtremor (OMT) across a diverse cohort, representative of the US population, with a view to establishing this as a standard measurement tool for OMT.
Read the detailed description
This multisite study intends to evaluate the performance of the iTremor device developed for the measurement of 'Ocular Microtremor' (OMT) - a very high frequency, very small vibration present in the eye. The iTremor is the first non-invasive technique to provide an output of OMT, reported as frequency (Hertz) at the point of care.
The current study is a prospective, observational, multicenter study of the safety and reliability of the iTremor device to obtain an ocular microtremor (OMT) measurement in subjects ≥18 years in a diverse cohort of the US population. By reporting the repeatability of the OMT reading, the study intends to support establishing this as a standard, point of care measurement tool for OMT.
- Conditions
- All Conditions, All
- Keywords
- OMT, Ocular microtremor, iTremor
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 'All comers' | Participants aged 18 and over representing the gender, age and racial diversity of the US population and of varied health status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the iTremor device to measure ocular microtremor (OMT) in a diverse US population.
To establish efficacy (performance/reliability) of iTremor to measure ocular mircotremor (OMT) reported in Hertz. Intra-operator, intra-device reliability will be assessed via repeated measures taken periprocedurally at one visit, utilizing the Intraclass Correlation Coefficient statistical tool (reported via single measures and average measures).
Measured: Repeated measures to be performed periprocedurally during a single visit (Day 1)
Secondary outcomes (3)
Reliability of the iTremor device to measure ocular microtremor (OMT) across operators.
To establish efficacy (performance/reliability) of iTremor to measure ocular microtremor (OMT) reported in Hertz. Inter-operator, intra-device reliability will be assessed across different operators via repeated measures taken periprocedurally at one visit, utilizing the Intraclass Correlation Coefficient statistical tool (reported via single measures and average measures).
Measured: Repeated measures performed periprocedurally during a single visit (Day 1)
Occurrence of adverse and or serious adverse events
To establish safety of the device, the rate of adverse events and serious adverse events believed to be procedure or device related will be evaluated. The timeframe for assessment of events is from the time of the procedure until 24 hours post procedure.
Measured: 24 hours from the time of the procedure.
Reporting the range of ocular microtremor (OMT) values across a diverse population assessed with the iTremor device .
Report the range of ocular microtremor (OMT) values measured and detected across a diverse population of participants ages, health status and ethnicity. Measurements will be taken with the iTremor device and results will be reported in Hertz. Measurements will be taken periprocedurally during one visit.
Measured: Repeated measures performed periprocedurally during a single visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for All ConditionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Head Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts Institute of Technology, Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858214
- Sponsor's protocol ID
- OMT_US
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined by investigator agreements.
Publications
Graham L, Das J, Vitorio R, McDonald C, Walker R, Godfrey A, Morris R, Stuart S. Ocular microtremor: a structured review. Exp Brain Res. 2023 Sep;241(9):2191-2203. doi: 10.1007/s00221-023-06691-w. Epub 2023 Aug 26.
PubMed 37632535
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Ocular Microtremor With the iTremor Device in a Diverse US Cohort
- ClinicalTrials.gov ID
- NCT07858214
- Acronym / sponsor ID
- OMT_US
- Conditions
- All Conditions, All
- Keywords
- OMT, Ocular microtremor, iTremor
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Head DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts Institute of Technology, Emory University
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Oct 2026 (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.
To evaluate the reliability of using the iTremor device to accurately measure Ocular Microtremor (OMT) across a diverse cohort, representative of the US population, with a view to establishing this as a standard measurement tool for OMT.
Detailed description
This multisite study intends to evaluate the performance of the iTremor device developed for the measurement of 'Ocular Microtremor' (OMT) - a very high frequency, very small vibration present in the eye. The iTremor is the first non-invasive technique to provide an output of OMT, reported as frequency (Hertz) at the point of care.
The current study is a prospective, observational, multicenter study of the safety and reliability of the iTremor device to obtain an ocular microtremor (OMT) measurement in subjects ≥18 years in a diverse cohort of the US population. By reporting the repeatability of the OMT reading, the study intends to support establishing this as a standard, point of care measurement tool for OMT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'All comers' | – | –Participants aged 18 and over representing the gender, age and racial diversity of the US population and of varied health status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll 120 US subjects total, 18 years of age and older, reflecting the gender, age and racial diversity of the US population. Health status and history will be documented to reflect an all-comers participant group.
Key inclusion criteria (4 listed)
- Adults 18 years of age or older.
- Normal or corrected to normal bilateral vision.
- Ability to sit and look forward for periods of at least 5 seconds.
- Communicate in English with the study team.
Key exclusion criteria (7 listed)
- Visible or known injuries to eye or eye socket.
- Non-intact periorbital skin
- Oculomotor palsy
- Strabismus (cross-eyedness) / impaired ocular mobility
- Inability to refrain from alcohol, cannabis or other recreational drugs for 24 hours prior to study visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of the iTremor device to measure ocular microtremor (OMT) in a diverse US population.
Time frame: Repeated measures to be performed periprocedurally during a single visit (Day 1)
To establish efficacy (performance/reliability) of iTremor to measure ocular mircotremor (OMT) reported in Hertz. Intra-operator, intra-device reliability will be assessed via repeated measures taken periprocedurally at one visit, utilizing the Intraclass Correlation Coefficient statistical tool (reported via single measures and average measures).
3 secondary outcomes
Reliability of the iTremor device to measure ocular microtremor (OMT) across operators.
Time frame: Repeated measures performed periprocedurally during a single visit (Day 1)
Occurrence of adverse and or serious adverse events
Time frame: 24 hours from the time of the procedure.
Reporting the range of ocular microtremor (OMT) values across a diverse population assessed with the iTremor device .
Time frame: Repeated measures performed periprocedurally during a single visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 37632535Graham L, Das J, Vitorio R, McDonald C, Walker R, Godfrey A, Morris R, Stuart S. Ocular microtremor: a structured review. Exp Brain Res. 2023 Sep;241(9):2191-2203. doi: 10.1007/s00221-023-06691-w. Epub 2023 Aug 26.
- Individual participant dataSharing planned: Undecided. To be determined by investigator agreements.
Related trials for All Conditions
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Conditions and All, run by Head Diagnostics at 2 sites 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Reliability of the iTremor device to measure ocular microtremor (OMT) in a diverse US population. (time frame: Repeated measures to be performed periprocedurally during a single visit (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07858214, which also lists 1 linked publication.
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 5 Oct 2026.