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

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: NCT01359774
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : September 21, 2012
Information provided by (Responsible Party):

May 23, 2011
May 25, 2011
September 21, 2012
April 2011
April 2012   (Final data collection date for primary outcome measure)
Brain energy deficit in Huntington patients [ Time Frame: one year ]

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.

Same as current
Complete list of historical versions of study NCT01359774 on ClinicalTrials.gov Archive Site
Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients [ Time Frame: one year ]

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.

Same as current
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31P-MRS and Huntington Disease
31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease
The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Huntington Disease
  • Other: 31P-MR spectroscopy
    Brain energy deficit is quantified using 31P-MR spectroscopy
  • Other: 31P-RMN spectroscopy
    Brain energy deficit is quantified using 31P-RMN spectroscopy
  • Healthy volunteers
    Intervention: Other: 31P-MR spectroscopy
  • Huntington patients
    Intervention: Other: 31P-RMN spectroscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2011-A00137-34 ( Registry Identifier: IDRCB )
Not Provided
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
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
Institut National de la Santé Et de la Recherche Médicale, France
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP