NCT05085704 Brain Metabolism Observed at 3 Tesla or 7 Tesla in Health and Metabolic Disease
| NCT ID | NCT05085704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Glut1 Deficiency Syndrome 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-05-03 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2022-05-03 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal is to develop methodology to monitor flux in the citric acid cycle in brain via 13C nuclear magnetic resonance (NMR) spectroscopy at 7 Tesla or 3 Tesla.
Eligibility Criteria
Inclusion Criteria: 1. Subjects will be adolescents or adults, age 16-80 years in good general health (evidenced by normal vital signs and no acute signs or symptoms of illness) or with previously (not for this study) documented G1D (genetically confirmed). 2. Ages 16 to 80 3. Persons with dental fillings, dental crowns, and short (max.4 cm) dental retainer wires can be included. Exclusion Criteria: 1. People or patients with uncontrolled seizure disorder, defined as grand mal (not absence) seizure in the preceding 3 months. 2. Pregnant females will be excluded. A serum or urine pregnancy test will be administered to all females of child bearing potential within 24 hours of administration of the tracer and MRI scan. The pregnancy test will be communicated in person by the study PI. Positive results in subjects 17 years old or younger will be disclosed to parent/guardian only. 3. Subjects with typical implanted orthopedic metal in bone may be considered for inclusion in a 7T scan providing the implant is not within the volume of the radio frequency coil. The PI and the AIRC Medical Director will discuss each case and determine eligibility. 4. Persons with ICD, pacemakers, neurostimulators and other such devices will be excluded. 5. Persons with claustrophobia are excluded. 6. Persons with questionable ferrous implants, bullets, BB's, and shrapnel will be excluded. 7. Subjects who are not fluent in English will be excluded because immediate cooperation and the ability to respond to instructions from the investigators are necessary. 8. People following a ketogenic diet
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05085704 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Glut1 Deficiency Syndrome 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05085704 currently recruiting?
Yes, NCT05085704 is actively recruiting participants. Contact the research team at jup9003@med.cornell.edu for enrollment information.
Where is the NCT05085704 trial being conducted?
This trial is being conducted at New York, United States, Dallas, United States.
Who is sponsoring the NCT05085704 clinical trial?
NCT05085704 is sponsored by Weill Medical College of Cornell University. The trial plans to enroll 20 participants.