Back to resultsUtilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease (PRO-MH2)
Primary Purpose
Huntington Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
31-Phosphorus RMN Spectroscopy
Sponsored by
About this trial
This is an interventional basic science trial for Huntington Disease
Eligibility 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
Sites / Locations
- Brain and Spine Institute (ICM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients
Volunteers
Arm Description
31-Phosphorus RMN Spectroscopy
31-Phosphorus RMN Spectroscopy
Outcomes
Primary Outcome Measures
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
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
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.
Patients will be retested after one month.
Full Information
NCT ID
NCT01696708
First Posted
September 20, 2012
Last Updated
March 8, 2017
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01696708
Brief Title
Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease
Acronym
PRO-MH2
Official Title
Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 6, 2012 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
31-Phosphorus RMN Spectroscopy
Arm Title
Volunteers
Arm Type
Other
Arm Description
31-Phosphorus RMN Spectroscopy
Intervention Type
Other
Intervention Name(s)
31-Phosphorus RMN Spectroscopy
Primary Outcome Measure Information:
Title
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
Description
31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Correlation between primary outcome measure and clinical parameters
Description
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).
Time Frame
2 years
Title
Study of longitudinal changes in Pi/PCr ratio over time.
Description
Patients will be retested after one month.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny Mochel, MD, PhD
Organizational Affiliation
INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain and Spine Institute (ICM)
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25568297
Citation
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.
Results Reference
derived
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Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease
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