ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01696708
Recruitment Status : Completed
First Posted : October 1, 2012
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.

Condition or disease Intervention/treatment Phase
Huntington Disease Other: 31-Phosphorus RMN Spectroscopy Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 6, 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Phosphorus
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Patients
31-Phosphorus RMN Spectroscopy
 Other: 31-Phosphorus RMN Spectroscopy
Volunteers
31-Phosphorus RMN Spectroscopy
 Other: 31-Phosphorus RMN Spectroscopy


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. Study of longitudinal changes in Pi/PCr ratio over time. [ Time Frame: 2 years ]
    Patients will be retested after one month.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01696708


Locations
France
Brain and Spine Institute (ICM)
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( Registry Identifier: IDRCB )
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: September 2012

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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