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Completed

NCT Number: NCT03346707

Safety and Feasibility of Imaging at 10.5 Tesla

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CMMR

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

10.5 Tesla

Device

10.5Tesla MR scan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

10.5T Safety and Feasibility Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2017
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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