NCT01359774

Brief Summary

The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 27, 2025

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

May 23, 2011

Last Update Submit

August 26, 2025

Conditions

Huntington Disease

Keywords

EnergyMetabolismSpectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients

    one year

Study Arms (2)

Healthy volunteers

OTHER
Other: 31P-MR spectroscopy

Huntington patients

OTHER
Other: 31P-RMN spectroscopy

Interventions

31P-MR spectroscopyOTHER

Brain energy deficit is quantified using 31P-MR spectroscopy

Healthy volunteers
31P-RMN spectroscopyOTHER

Brain energy deficit is quantified using 31P-RMN spectroscopy

Huntington patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<UHDRS\<50
  • Age\>18 years
  • Ability to undergo MR scanning
  • Covered by french social security

You may not qualify if:

  • 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
  • Unwillingness to be informed in case of abnormal MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la Pitié-Salpetrière

Paris, 75013, France

Location

Related Publications (4)

  • Mochel 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.

    PMID: 22517114BACKGROUND

  • 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.

    PMID: 21285522BACKGROUND

  • Mochel 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.

    PMID: 17653274BACKGROUND

  • Mochel 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.

    PMID: 21320997BACKGROUND

Related Links

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 27, 2025

Record last verified: 2012-09

Locations

FR(1)