Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease (PRO-MH2)
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ClinicalTrials.gov Identifier: NCT01696708 |
Recruitment Status
:
Completed
First Posted
: October 1, 2012
Last Update Posted
: March 9, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington Disease | Other: 31-Phosphorus RMN Spectroscopy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
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 |
Actual Study Start Date : | December 6, 2012 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |

Arm | Intervention/treatment |
---|---|
Patients
31-Phosphorus RMN Spectroscopy
|
Other: 31-Phosphorus RMN Spectroscopy |
Volunteers
31-Phosphorus RMN Spectroscopy
|
Other: 31-Phosphorus RMN Spectroscopy |
- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696708
France | |
Brain and Spine Institute (ICM) | |
Paris, France, 75013 |
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 |
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 ) |
First Posted: | October 1, 2012 Key Record Dates |
Last Update Posted: | March 9, 2017 |
Last Verified: | September 2012 |
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 |