31P-MRS and Huntington Disease

Huntington Disease Clinical Trial

— PRO-MH  

Official title:

31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359774
• Other study ID #: C10-56
• Secondary ID: 2011-A00137-34
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: September 20, 2012
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Other:
• 31P-MR spectroscopy
Brain energy deficit is quantified using 31P-MR spectroscopy
• 31P-RMN spectroscopy
Brain energy deficit is quantified using 31P-RMN spectroscopy

Locations

Country	Name	City	State
France	Hopital de la Pitié-Salpetrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	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.	one year	No

External Links

•   European Huntington's Disease Network