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

This study is currently recruiting participants.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France
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: June 7, 2013
Last verified: September 2012
  Purpose

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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients
31-Phosphorus RMN Spectroscopy
Other: 31-Phosphorus RMN Spectroscopy
Volunteers
31-Phosphorus RMN Spectroscopy
Other: 31-Phosphorus RMN Spectroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696708

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

Locations
France
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
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

No publications provided

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: June 7, 2013
Health Authority: France: Committee for the Protection of Personnes

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014