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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
First received: September 20, 2012
Last updated: April 30, 2015
Last verified: September 2012
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.

Condition Intervention
Huntington Disease
Other: 31-Phosphorus RMN Spectroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate

Secondary Outcome Measures:
  • Correlation between primary outcome measure and clinical parameters [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients will be retested after one month.

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
31-Phosphorus RMN Spectroscopy
Other: 31-Phosphorus RMN Spectroscopy
31-Phosphorus RMN Spectroscopy
Other: 31-Phosphorus RMN Spectroscopy


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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01696708

Contact: Daisy Rinaldi, PhD +33 1 57 27 46 78 daisy.rinaldi@icm-institute.org

Brain and Spine Institute (ICM) Recruiting
Paris, France, 75013
Contact: Daisy Rinaldi, PhD       daisy.rinaldi@icm-institute.org   
Sub-Investigator: Perrine Charles, MD         
Sub-Investigator: Alexandra Durr, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01696708     History of Changes
Other Study ID Numbers: C12-49  2012-A01063-40 
Study First Received: September 20, 2012
Last Updated: April 30, 2015
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 26, 2016