NCT01696708CompletedNot Applicable
Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease
Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country50 target enrollmentStarted: December 6, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
Study Overview
Brief Summary
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Patients
Other
31-Phosphorus RMN Spectroscopy
Intervention: 31-Phosphorus RMN Spectroscopy (Other)
Volunteers
Other
31-Phosphorus RMN Spectroscopy
Intervention: 31-Phosphorus RMN Spectroscopy (Other)
Outcomes
Primary Outcomes
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
Time Frame: 2 years
31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate
Secondary Outcomes
- Correlation between primary outcome measure and clinical parameters(2 years)
- Study of longitudinal changes in Pi/PCr ratio over time.(2 years)
Investigators
Study Sites (1)
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