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

Huntington Disease Clinical Trial

— PRO-MH2  

Official title:

Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696708
• Other study ID #: C12-49
• Secondary ID: 2012-A01063-40
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: March 8, 2017
• Start date: December 6, 2012
• Est. completion date: November 2015

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
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Other:
• 31-Phosphorus RMN Spectroscopy

Locations

Country	Name	City	State
France	Brain and Spine Institute (ICM)	Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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).	2 years
Secondary	Study of longitudinal changes in Pi/PCr ratio over time.	Patients will be retested after one month.	2 years