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Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease (PRO-MH2)

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:
NCT01696708
First received: September 20, 2012
Last updated: March 8, 2017
Last verified: September 2012
September 20, 2012
March 8, 2017
December 6, 2012
November 2015   (Final data collection date for primary outcome measure)
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr [ Time Frame: 2 years ]
31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate
Same as current
Complete list of historical versions of study NCT01696708 on ClinicalTrials.gov Archive Site
  • Correlation between primary outcome measure and clinical parameters [ Time Frame: 2 years ]
    Correlating a brain energy deficit with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).
  • Study of longitudinal changes in Pi/PCr ratio over time. [ Time Frame: 2 years ]
    Patients will be retested after one month.
Same as current
Not Provided
Not Provided
 
Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease
Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Huntington Disease
Other: 31-Phosphorus RMN Spectroscopy
  • Patients
    31-Phosphorus RMN Spectroscopy
    Intervention: Other: 31-Phosphorus RMN Spectroscopy
  • Volunteers
    31-Phosphorus RMN Spectroscopy
    Intervention: Other: 31-Phosphorus RMN Spectroscopy
Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01696708
C12-49
2012-A01063-40 ( Registry Identifier: IDRCB )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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