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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01359774
Date of registration: 23/05/2011
Prospective Registration: No
Primary sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Public title: 31P-MRS and Huntington Disease PRO-MH
Scientific title: 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease
Date of first enrolment: April 2011
Target sample size: 30
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01359774
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Fanny Mochel, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
Key inclusion & exclusion criteria

Inclusion Criteria:

- 5
- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Huntington Disease
Intervention(s)
Other: 31P-RMN spectroscopy
Other: 31P-MR spectroscopy
Primary Outcome(s)
Brain energy deficit in Huntington patients [Time Frame: one year]
Secondary Outcome(s)
Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients [Time Frame: one year]
Secondary ID(s)
C10-56
2011-A00137-34
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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