Mapping of Electrical Properties in the Brain

Study Purpose

This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aim 1: normal healthy volunteers.
  • - Aim 2, 3, 4: participants included in IRB 16-002424, including those that have undergone surgical biopsy/resection for suspected or known glioma.

Exclusion Criteria:

- Healthy volunteer unable to have an MRI

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06470711
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Leland S. Hu, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Glioma
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVES:

  • I. Optimize pulse sequence acquisitions for diffusion imaging on clinical MRI vendor systems.
  • II. Develop image-based MRI models (including diffusion-based MRI) that accurately depict the multi-regional electrical properties in the brain (e.g., resistivity, current) to inform of neural integrity and function (including white matter tract integrity) in diseased and non-diseased states.
  • III. Compare/correlate image-based MRI models (e.g., diffusion) with existing structural, physiologic, and functional MRI methods (e.g., tensor imaging, fMRI, DSC-MRI, etc).
  • IV. Further train image-based models/measurements with loco-regional benchmarks including (but not exclusive to) electrophysiologic monitoring, functional and structural tissue assays (from available biopsies), and correlative clinical features (e.g., histology, outcomes, treatment, etc).
OUTLINE: This is an observational study. Participants complete a survey and undergo MRI on study.

Arms & Interventions

Arms

: Observational

Participants complete a survey and undergo MRI on study.

Interventions

Other: - Non-Interventional Study

Non-interventional study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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