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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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