NCT02134561

Brief Summary

The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

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

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 22, 2020

Status Verified

February 1, 2013

Enrollment Period

4.9 years

First QC Date

April 10, 2014

Last Update Submit

October 20, 2020

Conditions

Presymptomatic Huntington Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years

    3 months before diagnostic (baseline) ; 2 years after diagnostic,

Study Arms (1)

All subjects

OTHER

psychological interview, MRI, neurological tests, cognitive tests

Behavioral: psychological interviewRadiation: MRIOther: cognitive testsOther: neurological tests

Interventions

psychological interviewBEHAVIORAL
All subjects
MRIRADIATION

This MRI is a specific intervention assign to the subjects of the study, that's why it is an interventionnal study

All subjects
cognitive testsOTHER
All subjects
neurological testsOTHER
All subjects

Eligibility Criteria

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

You may qualify if:

  • Applicants for Huntington's Disease and Presymptomatic Testing
  • Aged 18 years and above
  • Huntington disease family member
  • Subject gave its written consent

You may not qualify if:

  • No national health insurance affiliation
  • Being under guardianship
  • Patient with movement disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Angers

Angers, Pays de la Loire Region, 49933, France

Location

MeSH Terms

Interventions

Interview, PsychologicalNeuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TechniquesBehavioral Disciplines and ActivitiesPsychological Tests

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

May 9, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 22, 2020

Record last verified: 2013-02

Locations

FR(1)