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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
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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

Condition or disease Intervention/treatment
Huntington Disease Other: 31P-MR spectroscopy Other: 31P-RMN spectroscopy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease
Study Start Date : April 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Additional Information:
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 ( Registry Identifier: IDRCB )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012

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
Neurocognitive Disorders
Mental Disorders