Huntington DiseasePRO-MHNCT01359774
31P-MRS and Huntington Disease
A study testing 31P-MR spectroscopy and 31P-RMN spectroscopy in people with Huntington Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- 31P-MR spectroscopy and 31P-RMN spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 5<UHDRS<50
- Age>18 years
- Ability to undergo MR scanning
- Covered by french social security
Who cannot join
- Evidence of psychiatric disorder
- Attendant neurological disorder
- Contraindications to MRI (claustrophobia, metallic or material implants)
- Severe head injury
- Unable to understand the protocol
- Pregnancy
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease
The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.
- Conditions
- Huntington Disease
- Being tested
- 31P-MR spectroscopy, 31P-RMN spectroscopy
- Keywords
- Energy, Metabolism, Spectroscopy
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31P-MR spectroscopyOther
Brain energy deficit is quantified using 31P-MR spectroscopy
31P-RMN spectroscopyOther
Brain energy deficit is quantified using 31P-RMN spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Not described Receives: Other: 31P-MR spectroscopy |
| Huntington patients | Other | Not described Receives: Other: 31P-RMN spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain energy deficit in Huntington patients
31P-MRS allows quantification of high-energy phosphate metabolites such as ATP and phosphocreatine.
Objective: to look at brain energy metabolism during rest and activation.
Measured: one year
Secondary outcomes (1)
Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients
Biochemical parameters include metabolites that we previously showed to be biomarkers in HD: branched chain amino acids and IGF1.
Clinical parameters include UHDRS and TFC.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fanny Mochel, MD, PhD, Principal investigator, INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359774
- Sponsor's protocol ID
- C10-56
- Other IDs
- 2011-A00137-34
- Acronym
- PRO-MH
- Status last verified
- Sep 2012
- First submitted
- 23 May 2011
- Last updated
- 27 Aug 2025
- Results posted
- No
Publications
Mochel F, Haller RG. Energy deficit in Huntington disease: why it matters. J Clin Invest. 2011 Feb;121(2):493-9. doi: 10.1172/JCI45691. Epub 2011 Feb 1.
PubMed 21285522Mochel F, Charles P, Seguin F, Barritault J, Coussieu C, Perin L, Le Bouc Y, Gervais C, Carcelain G, Vassault A, Feingold J, Rabier D, Durr A. Early energy deficit in Huntington disease: identification of a plasma biomarker traceable during disease progression. PLoS One. 2007 Jul 25;2(7):e647. doi: 10.1371/journal.pone.0000647.
PubMed 17653274Mochel F, Benaich S, Rabier D, Durr A. Validation of plasma branched chain amino acids as biomarkers in Huntington disease. Arch Neurol. 2011 Feb;68(2):265-7. doi: 10.1001/archneurol.2010.358. No abstract available.
PubMed 21320997Mochel F, N'Guyen TM, Deelchand D, Rinaldi D, Valabregue R, Wary C, Carlier PG, Durr A, Henry PG. Abnormal response to cortical activation in early stages of Huntington disease. Mov Disord. 2012 Jun;27(7):907-10. doi: 10.1002/mds.25009. Epub 2012 Apr 19.
PubMed 22517114
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease
- ClinicalTrials.gov ID
- NCT01359774
- Acronym / sponsor ID
- PRO-MH / C10-56
- Conditions
- Huntington Disease
- Keywords
- Energy, Metabolism, Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: 31P-MR spectroscopy |
| Huntington patients | Other | Other: 31P-RMN spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 5<UHDRS<50
- Age>18 years
- Ability to undergo MR scanning
- Covered by french social security
Key exclusion criteria (9 listed)
- Evidence of psychiatric disorder
- Attendant neurological disorder
- Contraindications to MRI (claustrophobia, metallic or material implants)
- Severe head injury
- Unable to understand the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 31P-MR spectroscopyBrain energy deficit is quantified using 31P-MR spectroscopy | Other | Healthy volunteers |
| 31P-RMN spectroscopyBrain energy deficit is quantified using 31P-RMN spectroscopy | Other | Huntington patients |
Primary outcome
Brain energy deficit in Huntington patients
Time frame: one year
31P-MRS allows quantification of high-energy phosphate metabolites such as ATP and phosphocreatine. Objective: to look at brain energy metabolism during rest and activation.
1 secondary outcome
Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 21285522Mochel F, Haller RG. Energy deficit in Huntington disease: why it matters. J Clin Invest. 2011 Feb;121(2):493-9. doi: 10.1172/JCI45691. Epub 2011 Feb 1.
- Background: PubMed 17653274Mochel F, Charles P, Seguin F, Barritault J, Coussieu C, Perin L, Le Bouc Y, Gervais C, Carcelain G, Vassault A, Feingold J, Rabier D, Durr A. Early energy deficit in Huntington disease: identification of a plasma biomarker traceable during disease progression. PLoS One. 2007 Jul 25;2(7):e647. doi: 10.1371/journal.pone.0000647.
- Background: PubMed 21320997Mochel F, Benaich S, Rabier D, Durr A. Validation of plasma branched chain amino acids as biomarkers in Huntington disease. Arch Neurol. 2011 Feb;68(2):265-7. doi: 10.1001/archneurol.2010.358. No abstract available.
- Results publication: PubMed 22517114Mochel F, N'Guyen TM, Deelchand D, Rinaldi D, Valabregue R, Wary C, Carlier PG, Durr A, Henry PG. Abnormal response to cortical activation in early stages of Huntington disease. Mov Disord. 2012 Jun;27(7):907-10. doi: 10.1002/mds.25009. Epub 2012 Apr 19.
- European Huntington's Disease NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny Mochel, MD, PhD principal investigator
INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 31P-MR spectroscopy and 31P-RMN spectroscopy in people with Huntington Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain energy deficit in Huntington patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359774, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.