Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease (PRO-MH2)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was Recruiting
Recruitment status was Recruiting
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: June 7, 2013
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: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Patients will be retested after one month.
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
Contacts
| Contact: Daisy Rinaldi, PhD | +33 1 57 27 46 78 | daisy.rinaldi@icm-institute.org |
Locations
| France | |
| Brain and Spine Institute (ICM) | Recruiting |
| Paris, France, 75013 | |
| Contact: Daisy Rinaldi, PhD daisy.rinaldi@icm-institute.org | |
| Sub-Investigator: Perrine Charles, MD | |
| Sub-Investigator: Alexandra Durr, MD | |
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
No publications provided
| 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 |
| Study First Received: | September 20, 2012 |
| Last Updated: | June 7, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes |
Additional relevant MeSH terms:
|
Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Dementia |
Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on February 27, 2015