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31P-MRS and Huntington Disease (PRO-MH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01359774
First received: May 23, 2011
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.


Condition Intervention
Huntington Disease
 Other: 31P-MR spectroscopy
Other: 31P-RMN spectroscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Brain energy deficit in Huntington patients [ Time Frame: one year ] [ Designated as safety issue: No ]

    31P-MRS allows quantification of high-energy phosphate metabolites such as ATP and phosphocreatine.

    Objective: to look at brain energy metabolism during rest and activation.



Secondary Outcome Measures:
  • Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients [ Time Frame: one year ] [ Designated as safety issue: No ]

    Biochemical parameters include metabolites that we previously showed to be biomarkers in HD: branched chain amino acids and IGF1.

    Clinical parameters include UHDRS and TFC.



Enrollment: 30
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy volunteers Other: 31P-MR spectroscopy
Brain energy deficit is quantified using 31P-MR spectroscopy
Huntington patients Other: 31P-RMN spectroscopy
Brain energy deficit is quantified using 31P-RMN spectroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5<UHDRS<50
  • Age>18 years
  • Ability to undergo MR scanning
  • Covered by french social security

Exclusion Criteria:

  • Evidence of psychiatric disorder
  • Attendant neurological disorder
  • Contraindications to MRI (claustrophobia, metallic or material implants)
  • Severe head injury
  • Unable to understand the protocol
  • Pregnancy
  • Failure to give informed consent
  • Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
  • Unwillingness to be informed in case of abnormal MRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359774

Locations
France
Hopital de la Pitié-Salpetrière
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Fanny Mochel, MD, PhD INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
  More Information

Additional Information:
European Huntington's Disease Network  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01359774     History of Changes
Other Study ID Numbers: C10-56, 2011-A00137-34
Study First Received: May 23, 2011
Last Updated: September 20, 2012
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Energy
Metabolism
Spectroscopy

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013