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31P-MRS and Huntington Disease (PRO-MH)

Primary Purpose

Huntington Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
31P-MR spectroscopy
31P-RMN spectroscopy
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Huntington Disease focused on measuring Energy, Metabolism, Spectroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 5<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

  • Hopital de la Pitié-Salpetrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy volunteers

Huntington patients

Arm Description

Outcomes

Primary Outcome Measures

Brain energy deficit in Huntington patients
31P-MRS allows quantification of high-energy phosphate metabolites such as ATP and phosphocreatine. Objective: to look at brain energy metabolism during rest and activation.

Secondary Outcome Measures

Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients
Biochemical parameters include metabolites that we previously showed to be biomarkers in HD: branched chain amino acids and IGF1. Clinical parameters include UHDRS and TFC.

Full Information

First Posted
May 23, 2011
Last Updated
September 20, 2012
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01359774
Brief Title
31P-MRS and Huntington Disease
Acronym
PRO-MH
Official Title
31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (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

5. Study Description

Brief Summary
The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Energy, Metabolism, Spectroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Other
Arm Title
Huntington patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
31P-MR spectroscopy
Intervention Description
Brain energy deficit is quantified using 31P-MR spectroscopy
Intervention Type
Other
Intervention Name(s)
31P-RMN spectroscopy
Intervention Description
Brain energy deficit is quantified using 31P-RMN spectroscopy
Primary Outcome Measure Information:
Title
Brain energy deficit in Huntington patients
Description
31P-MRS allows quantification of high-energy phosphate metabolites such as ATP and phosphocreatine. Objective: to look at brain energy metabolism during rest and activation.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients
Description
Biochemical parameters include metabolites that we previously showed to be biomarkers in HD: branched chain amino acids and IGF1. Clinical parameters include UHDRS and TFC.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 5<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
Hopital de la Pitié-Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21285522
Citation
Mochel F, Haller RG. Energy deficit in Huntington disease: why it matters. J Clin Invest. 2011 Feb;121(2):493-9. doi: 10.1172/JCI45691. Epub 2011 Feb 1.
Results Reference
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PubMed Identifier
17653274
Citation
Mochel F, Charles P, Seguin F, Barritault J, Coussieu C, Perin L, Le Bouc Y, Gervais C, Carcelain G, Vassault A, Feingold J, Rabier D, Durr A. Early energy deficit in Huntington disease: identification of a plasma biomarker traceable during disease progression. PLoS One. 2007 Jul 25;2(7):e647. doi: 10.1371/journal.pone.0000647.
Results Reference
background
PubMed Identifier
21320997
Citation
Mochel F, Benaich S, Rabier D, Durr A. Validation of plasma branched chain amino acids as biomarkers in Huntington disease. Arch Neurol. 2011 Feb;68(2):265-7. doi: 10.1001/archneurol.2010.358. No abstract available.
Results Reference
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Links:
URL
http://www.euro-hd.net
Description
European Huntington's Disease Network

Learn more about this trial

31P-MRS and Huntington Disease

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