TCA Cycle in the Dentate in Friedreich's Ataxia

Friedreich Ataxia Clinical Trial

Official title:

Measurement of the TCA Cycle Rate in the Dentate Nucleus in Friedreich's Ataxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122925
• Other study ID #: RAD-2017-25500
• Status: Completed
• Start date: August 29, 2017
• Est. completion date: January 11, 2023

Study information

• Verified date: March 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Friedreich Ataxia

Intervention

Device:
• MR
MR

Locations

Country	Name	City	State
United States	CMRR	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TCA cycle rate in the dentate nucleus	value between 0 to 2 micromol/g/min	Baseline