NCT06774443

Brief Summary

Huntington's disease (HD) is an autosomal dominant neurodegenerative disorder, characterized by movement disorders, behavioural disorders and cognitive decline. Especially the behavioural and cognitive symptoms of the disease lead to significant disability and burden for patients as well as caregivers. One of the cognitive domains affected by HD is social cognition. Social cognition is the ability to perceive, interpret and respond correctly to social information. Aspects of social cognition are emotion recognition, perspective taking (Theory of Mind), and emapathy. Social cognition problems can be related to behavioural problems, but to be able to study this relationship, it is important to be able to reliable measure social cognition impairments. There are a few social cognition tests available, but often they are not normd and validated for use in a Dutch neurological population. There is a lack of sensitive, simple, tests for measuring Theory of Mind in patients with HD. A promising test, that already has been proven valid in a psychiatric population, is the Hinting Task. The Hinting Task measures theory of mind through indirect speech, The Hinting task is a social cognition test, where hints are implicitly given in speech, which resembles what patients and caregivers frequently report as difficult in HD. The Hinting Task has already been translated into Dutch and is already being used in clinical parctice, but its sensitivity has not been studied yet in a neurological population. The aim of this study is to assess if the Hinting Task is sensitive in patients with HD and to relate the Hinting Task to other (social) cognitive measures, demographical characteristics and disease characteristics.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

December 3, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 29, 2026

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

December 3, 2024

Last Update Submit

January 27, 2026

Conditions

Keywords

Social CognitionTheory of MindHinting TaskHuntingtonCAG repeat

Outcome Measures

Primary Outcomes (1)

  • Performance on the Hinting Task

    Performance on the Hinting Task by patients with Huntington's disease compared to healthy controls

    2025-2026

Secondary Outcomes (1)

  • Relations of the Hinting Task with other variables

    2025-2026

Study Arms (1)

Patients with HD

Will undergo a neuropsychological assessment

Other: Neuropsychological assessment

Interventions

Neuropsychological assessment consisting of tests measuring social cognition and memory

Patients with HD

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We aim to include 47 patients with premanifest HD and 20 patients with manifest HD. Patients will be recruited from the Enroll-HD sample of the UMCG and the Huntington outpatient clinic of Noorderbreedte in Grou. All stuParticipants of Enroll-HD that have given consent to be asked to take part in other studies of HD, will be asked to participate in the current study. The study will also be advertised on the website of the Dutch Huntington Society. Participants can sign themselves up via that advertisement. Inclusion and all other study-related activities will be performed by UMCG study staff. Data of healthy controls on the Hinting Task has already been obtained from previous studies, and can be used in accordance with the FAIR data principles. Data of healthy controls that have given permission to use their data in similar studies will be included. Controls will be matched to patients so that sex and age distributions do not significantly differ between groups.

You may qualify if:

  • Confirmed diagnosis of Huntington's disease via CAG-repeat length analysis, minimum of 40 repeats
  • Between 18 and 74 years of age
  • Dutch speaking

You may not qualify if:

  • Presence of serious psychiatric disorders or other neurological comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Interventions

Neuropsychological Tests

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)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Maraike Coenen

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maraike A. Coenen

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 14, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 29, 2026

Record last verified: 2025-11

Locations