NCT02551705

Brief Summary

Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the western world it affects 5-10 persons per 100000. The main brain changes include the loss of brain cells in subcortical structures. The symptoms of HD include involuntary movements, cognitive deterioration and behavioural disturbances. It has been shown that changes in emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in perception of emotions has been primarily investigated by means of facial expressions. However, emotions can also be expressed through body language. Here, the investigators propose to investigate whether the emotion comprehension deficit in preHD also includes body language comprehension.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

September 7, 2015

Last Update Submit

September 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Significant group differences in brain activation for perceiving emotional vs neutral faces by following random effects analyses

    Significant group differences in beta-values for the contrast emotional faces vs neutral faces following general linear model parameter estimates

    6 months

Study Arms (2)

functional Imaging mutation carrier

EXPERIMENTAL

Premanifest mutation carrier, behavioral and neural emotional memory processing

Other: functional Imaging

functional Imaging non-carrier

ACTIVE COMPARATOR

non-carrier family member, behavioral and neural emotional memory processing

Other: functional Imaging

Interventions

Brain responses associated with emotional memory will be investigated

functional Imaging mutation carrierfunctional Imaging non-carrier

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Huntington's disease positive genotype and non-carrier siblings

You may not qualify if:

  • visible chorea
  • MRI contra-indications
  • major neurological/psychiatric comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Huntington Disease

Interventions

Functional Neuroimaging

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

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral researcher

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 16, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

September 16, 2015

Record last verified: 2015-09