HealthyNCT03346707
Safety and Feasibility of Imaging at 10.5 Tesla
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
This unique NMR instrument is the first of its kind, and the most advanced system that is capable of brain, torso and extremity imaging in humans at such a high magnetic field. It will be transformative in performance relative to 7Tesla, and significantly expand the capabilities of multinuclear MRI, fMRI… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 10.5 Tesla
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 1 Sep 2022
- Phase
- Observational
- 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
Study population: Healthy Controsl
Who may be able to join
- Age 18 and 70
- Able to self-consent
- Weight less than 190 pounds
- Participated in high field MRI studies (7T or higher)
Who cannot join
- Subjects with metallic, magnetic, and/or electrically conductive implants or external devices.
- Ferromagnetic implants
- Any foreign metal objects in the body
- History of shrapnel or shot gun injury
- Cardiac pacemakers
- Defibrillator
Show all 13Show fewer
- Neuronal stimulator
- Magnetic aneurysm clip
- Large tattoos on the abdomen or the brain and neck
- Hip replacement
- Too large to fit in the magnet (body mass index >= 40, approx.)
- Severe claustrophobia
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 10.5T Safety and Feasibility Study
This unique NMR instrument is the first of its kind, and the most advanced system that is capable of brain, torso and extremity imaging in humans at such a high magnetic field. It will be transformative in performance relative to 7Tesla, and significantly expand the capabilities of multinuclear MRI, fMRI, morphological imaging, MRS etc. in the human brain and body.
In addition, to the known and potential benefits of performing anatomic and functional imaging studies at 10.5T, there are also known short-term side effects associated with subjecting humans to such high magnetic fields. This protocol will study the magnitude and variability of the short term and long term physiological, cognitive and vestibular effects while also assessing the feasibility of acquiring the types of data needed for translating research protocols onto this higher field strength scanner.
- Conditions
- Healthy
- Being tested
- 10.5 Tesla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10.5 TeslaDevice
10.5Tesla MR scan
| Study group | Role | What they receive |
|---|---|---|
| 10.5 Tesla | Not described Receives: Device: 10.5 Tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic effects of human exposure to 10.5T (Blood Pressure).
Change in blood pressure will be studied when exposed to 10.5T. Systolic and diastolic pressures (mmHg) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Physiologic effects of human exposure to 10.5T (Heart Rate).
Change in heart rate will be studied when exposed to 10.5T. Heart rate (beats per minute) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Physiologic effects of human exposure to 10.5T (Peripheral Capillary Oxygen Saturation (SPO2)).
Change in peripheral capillary oxygen saturation will be studied when exposed to 10.5T. Peripheral capillary oxygen saturation (%) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Physiologic effects of human exposure to 10.5T (Respiration Rate).
Change in respiration rate will be studied when exposed to 10.5T. Respiration rate (breaths per minute) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Cognitive effects of human exposure to 10.5T (Brief Fatigue Inventory).
Change in cognitive function will be studied when exposed to 10.5T using Brief Fatigue Inventory. Brief Fatigue Inventory (average score) will be administered before first 10.5T exposure, day after first 10.5T exposure, before second 10.5T exposure, and day after second 10.5T exposure.
Measured: Baseline and 2-4 weeks
Cognitive effects of human exposure to 10.5T (Letter Number Sequencing).
Change in cognitive function will be studied when exposed to 10.5T using Letter Number Sequencing. Letter Number Sequencing (total raw score) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Cognitive effects of human exposure to 10.5T (Digit Span Test).
Change in cognitive function will be studied when exposed to 10.5T using Digit Span Test. Digit Span Test (total raw score) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Cognitive effects of human exposure to 10.5T (Hopkins Verbal Test).
Change in cognitive function will be studied when exposed to 10.5T using Hopkins Verbal Test. Hopkins Verbal Test (total recall, delayed recall, retention %, recognition discrimination index) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Cognitive effects of human exposure to 10.5T (Symbol Digit Modalities Test).
Change in cognitive function will be studied when exposed to 10.5T using Symbol Digit Modalities Test. Symbol Digit Modalities Test (# correct in 90 seconds) will be administered before first 10.5T exposure after first 10.5T exposure, before second 10.5T exposure, and after second 10.5T exposure.
Measured: Baseline and 2-4 weeks
Cognitive effects of human exposure to 10.5T (Trail Making Test).
Change in cognitive function will be studied when exposed to 10.5T using Trail Making Test. Trail Making Test (time to completion) will be administered before first 10.5T exposure after first 10.5T exposure, before second 10.5T exposure, and after second 10.5T exposure.
Measured: Baseline and 2-4 weeks
Vestibular effects of human exposure to 10.5T (Activity-specific Balance Confidence Scale).
Change in vestibular function will be studied when exposed to 10.5T using Activity-specific Balance Confidence Scale. Activity-specific Balance Confidence Scale (% of self confidence) will be administered before first 10.5T exposure, day after first 10.5T exposure, before second 10.5T exposure, and day after second 10.5T exposure.
Measured: Baseline and 2-4 weeks
Vestibular effects of human exposure to 10.5T (Smooth Pursuit).
Change in vestibular function will be studied when exposed to 10.5T using smooth pursuit test. Smooth pursuit test (# of saccades for 4 types of eye movements) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Vestibular effects of human exposure to 10.5T (Spontaneous Eye Movement).
Change in vestibular function will be studied when exposed to 10.5T using spontaneous eye movement test. Spontaneous eye movement test (# of saccades with and without fixation) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Measured: Baseline and 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Dec 2017
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346707
- Sponsor's protocol ID
- RAD-2017-24570
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2017
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10.5T Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03346707
- Acronym / sponsor ID
- RAD-2017-24570
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 17 Nov 2017 (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.
This unique NMR instrument is the first of its kind, and the most advanced system that is capable of brain, torso and extremity imaging in humans at such a high magnetic field. It will be transformative in performance relative to 7Tesla, and significantly expand the capabilities of multinuclear MRI, fMRI, morphological imaging, MRS etc. in the human brain and body.
In addition, to the known and potential benefits of performing anatomic and functional imaging studies at 10.5T, there are also known short-term side effects associated with subjecting humans to such high magnetic fields. This protocol will study the magnitude and variability of the short term and long term physiological, cognitive and vestibular effects while also assessing the feasibility of acquiring the types of data needed for translating research protocols onto this higher field strength scanner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10.5 Tesla | – | Device: 10.5 Tesla |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Controsl
Key inclusion criteria (4 listed)
- Age 18 and 70
- Able to self-consent
- Weight less than 190 pounds
- Participated in high field MRI studies (7T or higher)
Key exclusion criteria (13 listed)
- Subjects with metallic, magnetic, and/or electrically conductive implants or external devices.
- Ferromagnetic implants
- Any foreign metal objects in the body
- History of shrapnel or shot gun injury
- Cardiac pacemakers
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 |
|---|---|---|
| 10.5 Tesla10.5Tesla MR scan | Device | 10.5 Tesla |
Primary outcome
Physiologic effects of human exposure to 10.5T (Blood Pressure).
Time frame: Baseline and 2-4 weeks
Change in blood pressure will be studied when exposed to 10.5T. Systolic and diastolic pressures (mmHg) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Physiologic effects of human exposure to 10.5T (Heart Rate).
Time frame: Baseline and 2-4 weeks
Change in heart rate will be studied when exposed to 10.5T. Heart rate (beats per minute) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Physiologic effects of human exposure to 10.5T (Peripheral Capillary Oxygen Saturation (SPO2)).
Time frame: Baseline and 2-4 weeks
Change in peripheral capillary oxygen saturation will be studied when exposed to 10.5T. Peripheral capillary oxygen saturation (%) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Physiologic effects of human exposure to 10.5T (Respiration Rate).
Time frame: Baseline and 2-4 weeks
Change in respiration rate will be studied when exposed to 10.5T. Respiration rate (breaths per minute) will be measured before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Cognitive effects of human exposure to 10.5T (Brief Fatigue Inventory).
Time frame: Baseline and 2-4 weeks
Change in cognitive function will be studied when exposed to 10.5T using Brief Fatigue Inventory. Brief Fatigue Inventory (average score) will be administered before first 10.5T exposure, day after first 10.5T exposure, before second 10.5T exposure, and day after second 10.5T exposure.
Cognitive effects of human exposure to 10.5T (Letter Number Sequencing).
Time frame: Baseline and 2-4 weeks
Change in cognitive function will be studied when exposed to 10.5T using Letter Number Sequencing. Letter Number Sequencing (total raw score) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Cognitive effects of human exposure to 10.5T (Digit Span Test).
Time frame: Baseline and 2-4 weeks
Change in cognitive function will be studied when exposed to 10.5T using Digit Span Test. Digit Span Test (total raw score) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Cognitive effects of human exposure to 10.5T (Hopkins Verbal Test).
Time frame: Baseline and 2-4 weeks
Change in cognitive function will be studied when exposed to 10.5T using Hopkins Verbal Test. Hopkins Verbal Test (total recall, delayed recall, retention %, recognition discrimination index) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Cognitive effects of human exposure to 10.5T (Symbol Digit Modalities Test).
Time frame: Baseline and 2-4 weeks
Change in cognitive function will be studied when exposed to 10.5T using Symbol Digit Modalities Test. Symbol Digit Modalities Test (# correct in 90 seconds) will be administered before first 10.5T exposure after first 10.5T exposure, before second 10.5T exposure, and after second 10.5T exposure.
Cognitive effects of human exposure to 10.5T (Trail Making Test).
Time frame: Baseline and 2-4 weeks
Change in cognitive function will be studied when exposed to 10.5T using Trail Making Test. Trail Making Test (time to completion) will be administered before first 10.5T exposure after first 10.5T exposure, before second 10.5T exposure, and after second 10.5T exposure.
Vestibular effects of human exposure to 10.5T (Activity-specific Balance Confidence Scale).
Time frame: Baseline and 2-4 weeks
Change in vestibular function will be studied when exposed to 10.5T using Activity-specific Balance Confidence Scale. Activity-specific Balance Confidence Scale (% of self confidence) will be administered before first 10.5T exposure, day after first 10.5T exposure, before second 10.5T exposure, and day after second 10.5T exposure.
Vestibular effects of human exposure to 10.5T (Smooth Pursuit).
Time frame: Baseline and 2-4 weeks
Change in vestibular function will be studied when exposed to 10.5T using smooth pursuit test. Smooth pursuit test (# of saccades for 4 types of eye movements) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Vestibular effects of human exposure to 10.5T (Spontaneous Eye Movement).
Time frame: Baseline and 2-4 weeks
Change in vestibular function will be studied when exposed to 10.5T using spontaneous eye movement test. Spontaneous eye movement test (# of saccades with and without fixation) will be administered before, during, and after 10.5T exposure at baseline and 2-4 weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Healthy, run by University of Minnesota 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 18 Oct 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physiologic effects of human exposure to 10.5T (Blood Pressure). (time frame: Baseline and 2-4 weeks). The study lists 13 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 18 Oct 2022.