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

Not Applicable

Completed

• Conditions: Huntington Disease
• Interventions: Other: 31-Phosphorus RMN Spectroscopy

• Registration Number: NCT01696708
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-10-01
• Study Start: 2012-12-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	31-Phosphorus RMN Spectroscopy	31-Phosphorus RMN Spectroscopy
Volunteers	31-Phosphorus RMN Spectroscopy	31-Phosphorus RMN Spectroscopy

Primary Outcome Measures

Name	Time	Method
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr	2 years	31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate

Secondary Outcome Measures

Name	Time	Method
Correlation between primary outcome measure and clinical parameters	2 years	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.	2 years	Patients will be retested after one month.

Trial Locations

Locations (1)

Brain and Spine Institute (ICM); 🇫🇷 Paris, France