ClinicalTrials.gov
ClinicalTrials.gov Menu

TCA Cycle in the Dentate in Friedreich's Ataxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03122925
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

OBJECTIVE: To measure the tricarboxylic acid (TCA) cycle rate in the dentate nucleus in a group of control subjects and subjects with Friedreich's Ataxia (FRDA).

HYPOTHESIS: The TCA cycle rate will be lower in FRDA subjects than in controls APPROACH: The investigators will infuse carbon-13 (13C) labeled glucose and measure the rate of 13C label incorporation from glucose to glutamate in the brain using in vivo magnetic resonance spectroscopy.


Condition or disease Intervention/treatment
Friedreich Ataxia Device: MR

Detailed Description:

The investigators will measure the TCA cycle rate in the dentate nucleus in a group of FRDA patients and in a group of age-matched healthy controls using 13C MRS in vivo together with systemic i.v. infusion of 13C-labeled glucose.

The investigators aim to obtain adequate data in 16 subjects grouped as follows:

  • n=4 pilot subjects (healthy subjects) for testing and optimization of the experimental setup.
  • n=6 healthy controls
  • n=6 FRDA patients

In other to reach this goal, the investigators plan to recruit up to 20 subjects, in case some subjects withdraw before completion of the MR scan, or in case the measured data are not adequate (e.g. technical problem with the scanner).


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Measurement of the TCA Cycle Rate in the Dentate Nucleus in Friedreich's Ataxia
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 1, 2019


Group/Cohort Intervention/treatment
Control
Healthy subjects
Device: MR
MR

Friedreich's Ataxia
Diagnosed for Friedreich's Ataxia
Device: MR
MR




Primary Outcome Measures :
  1. TCA cycle rate in the dentate nucleus [ Time Frame: Baseline ]
    value between 0 to 2 micromol/g/min


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy controls Friedreich's Ataxia diagnosis
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • able to consent for themselves
  • considered healthy (controls) OR be diagnosed with FRDA.

Exclusion Criteria:

  • All subjects:
  • Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
  • Pregnancy
  • Clautrophobia
  • Diabetes
  • Clinically significant cardiac disease

Control subjects:

- Neurological disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122925


Locations
United States, Minnesota
CMRR
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Pierre-Gilles Henry, PhD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03122925     History of Changes
Other Study ID Numbers: STUDY00000143
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ataxia
Cerebellar Ataxia
Friedreich Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinocerebellar Degenerations
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases