Clinical trial NCT03346707: Safety and Feasibility of Imaging at 10.5 Tesla
Official title: 10.5T Safety and Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Controsl

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18 and 70
2. Able to self-consent
3. Weight less than 190 pounds
4. Participated in high field MRI studies (7T or higher)

Exclusion Criteria:

Subjects with metallic, magnetic, and/or electrically conductive implants or external devices.

1. Ferromagnetic implants
2. Any foreign metal objects in the body
3. History of shrapnel or shot gun injury
4. Cardiac pacemakers
5. Defibrillator
6. Neuronal stimulator
7. Magnetic aneurysm clip
8. Large tattoos on the abdomen or the brain and neck
9. Hip replacement
10. Too large to fit in the magnet (body mass index \>= 40, approx.)
11. Severe claustrophobia
12. Women who are pregnant

Primary outcomes:
measure: Physiologic effects of human exposure to 10.5T (Blood Pressure).
timeFrame: Baseline and 2-4 weeks
measure: Physiologic effects of human exposure to 10.5T (Heart Rate).
timeFrame: Baseline and 2-4 weeks
measure: Physiologic effects of human exposure to 10.5T (Peripheral Capillary Oxygen Saturation (SPO2)).
timeFrame: Baseline and 2-4 weeks
measure: Physiologic effects of human exposure to 10.5T (Respiration Rate).
timeFrame: Baseline and 2-4 weeks
measure: Cognitive effects of human exposure to 10.5T (Brief Fatigue Inventory).
timeFrame: Baseline and 2-4 weeks
measure: Cognitive effects of human exposure to 10.5T (Letter Number Sequencing).
timeFrame: Baseline and 2-4 weeks
measure: Cognitive effects of human exposure to 10.5T (Digit Span Test).
timeFrame: Baseline and 2-4 weeks
measure: Cognitive effects of human exposure to 10.5T (Hopkins Verbal Test).
timeFrame: Baseline and 2-4 weeks
measure: Cognitive effects of human exposure to 10.5T (Symbol Digit Modalities Test).
timeFrame: Baseline and 2-4 weeks
measure: Cognitive effects of human exposure to 10.5T (Trail Making Test).
timeFrame: Baseline and 2-4 weeks
measure: Vestibular effects of human exposure to 10.5T (Activity-specific Balance Confidence Scale).
timeFrame: Baseline and 2-4 weeks
measure: Vestibular effects of human exposure to 10.5T (Smooth Pursuit).
timeFrame: Baseline and 2-4 weeks
measure: Vestibular effects of human exposure to 10.5T (Spontaneous Eye Movement).
timeFrame: Baseline and 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: CMMR
state: Minnesota
Study officials:
References: