NCT03346707|CompletedDMCFDA Device
Safety and Feasibility of Imaging at 10.5 Tesla
10.5T Safety and Feasibility Study
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10.5T Safety and Feasibility Study
Sponsor study identifier
observational
39
1 country
1
Study Start
December 15, 2017
Actual (reported)Primary Completion
September 1, 2022
Actual (reported)Study Completion
September 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2022
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2017
Actual (reported)November 17, 2017
Actual (reported)December 15, 2017
Actual (reported)September 1, 2022
Actual (reported)September 1, 2022
Actual (reported)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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Baseline and 2-4 weeks
10.5Tesla MR scan
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy Controsl
CMMR
Minneapolis, Minnesota, 55414, United States
39 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2017
First Posted
November 17, 2017
Study Start
December 15, 2017
Actual (reported)Effect of Aspirin on Gut Microbiome
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2022
Actual (reported)Study Completion
September 1, 2022
Actual (reported)Last Updated
October 18, 2022
Record last verified: 2022-10
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Source: ClinicalTrials.gov.
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