NCT03122925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

5.4 years

First QC Date

April 18, 2017

Last Update Submit

March 24, 2023

Conditions

Friedreich Ataxia

Outcome Measures

Primary Outcomes (1)

  • TCA cycle rate in the dentate nucleus

    value between 0 to 2 micromol/g/min

    Baseline

Study Arms (2)

Control

Healthy subjects

Device: MR

Friedreich's Ataxia

Diagnosed for Friedreich's Ataxia

Device: MR

Interventions

MRDEVICE

MR

ControlFriedreich's Ataxia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy controls Friedreich's Ataxia diagnosis

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMRR

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Friedreich Ataxia

Condition Hierarchy (Ancestors)

Spinocerebellar DegenerationsCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMitochondrial DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pierre-Gilles Henry, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 21, 2017

Study Start

August 29, 2017

Primary Completion

January 11, 2023

Study Completion

January 11, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)