Safety and Feasibility of Imaging at 10.5 Tesla

• Sponsor: University of Minnesota (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03346707
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 56.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: 10.5 Tesla

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 10.5T Safety and Feasibility Study
• Actual Study Start Date: Dec 15, 2017
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
10.5 Tesla	Device: 10.5 Tesla; 10.5Tesla MR scan

Outcome Measures

Primary Outcome Measures

1. Physiologic effects of human exposure to 10.5T (Blood Pressure). [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.

2. Physiologic effects of human exposure to 10.5T (Heart Rate). [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.

3. Physiologic effects of human exposure to 10.5T (Peripheral Capillary Oxygen Saturation (SPO2)). [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.

4. Physiologic effects of human exposure to 10.5T (Respiration Rate). [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.

5. Cognitive effects of human exposure to 10.5T (Brief Fatigue Inventory). [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.

6. Cognitive effects of human exposure to 10.5T (Letter Number Sequencing). [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.

7. Cognitive effects of human exposure to 10.5T (Digit Span Test). [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.

8. Cognitive effects of human exposure to 10.5T (Hopkins Verbal Test). [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.

9. Cognitive effects of human exposure to 10.5T (Symbol Digit Modalities Test). [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.

10. Cognitive effects of human exposure to 10.5T (Trail Making Test). [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.

11. Vestibular effects of human exposure to 10.5T (Activity-specific Balance Confidence Scale). [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.

12. Vestibular effects of human exposure to 10.5T (Smooth Pursuit). [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.

13. Vestibular effects of human exposure to 10.5T (Spontaneous Eye Movement). [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMMR	Minneapolis	Minnesota	United States	55414

Sponsors and Collaborators

• University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03346707
• Other Study ID Numbers: RAD-2017-24570
• First Posted: Nov 17, 2017
• Last Update Posted: Sep 28, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Sep 28, 2021