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Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease (PRO-MH2)
This study has been completed.
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01696708
First received: September 20, 2012
Last updated: March 8, 2017
Last verified: September 2012
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Purpose
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.
| Condition | Intervention |
|---|---|
| Huntington Disease | Other: 31-Phosphorus RMN Spectroscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
| Official Title: | Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease |
Resource links provided by NLM:
MedlinePlus related topics:
Huntington's Disease
Drug Information available for:
Phosphorus
U.S. FDA Resources
Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:
Primary Outcome Measures:
- 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 Outcome Measures:
- Correlation between primary outcome measure and clinical parameters [ Time Frame: 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. [ Time Frame: 2 years ]Patients will be retested after one month.
| Enrollment: | 50 |
| Actual Study Start Date: | December 6, 2012 |
| Study Completion Date: | November 2015 |
| Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Patients
31-Phosphorus RMN Spectroscopy
|
Other: 31-Phosphorus RMN Spectroscopy |
|
Volunteers
31-Phosphorus RMN Spectroscopy
|
Other: 31-Phosphorus RMN Spectroscopy |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696708
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696708
Locations
| France | |
| Brain and Spine Institute (ICM) | |
| Paris, France, 75013 | |
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
| Principal Investigator: | Fanny Mochel, MD, PhD | INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
| ClinicalTrials.gov Identifier: | NCT01696708 History of Changes |
| Other Study ID Numbers: |
C12-49 2012-A01063-40 ( Registry Identifier: IDRCB ) |
| Study First Received: | September 20, 2012 |
| Last Updated: | March 8, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias |
Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on August 18, 2017