Safety and Feasibility of Imaging at 10.5 Tesla

NCT03346707 | Completed DMC FDA Device

• 1 other identifier: RAD-2017-24570
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (1)

10.5 Tesla

Device: 10.5 Tesla

Interventions

10.5 Tesla DEVICE

10.5Tesla MR scan

10.5 Tesla

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Controsl

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

CMMR

Minneapolis, Minnesota, 55414, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: November 17, 2017
• Study Start: December 15, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)