NCT06828471

Brief Summary

Individuals with Huntington's Disease have impaired social cognition, which is the domain of cognition that allows individuals to understand others' perspectives so that they can navigate interpersonal actions successfully (e.g., understanding someone may be sad based of their facial emotion or tone of voice and then responding in a sympathetic manner). Impaired social cognition is associated with impaired social functioning, poor psychological wellbeing and increased caregiver burden, which is known to be significant among those who care for individuals with Huntington's Disease. Computerized social cognition training has been shown to improve social cognition in individuals with schizophrenia, who, like individuals with Huntington's disease, have cognitive impairments. The investigators propose a pilot study of computerized social cognition training in individuals with Huntington's disease. This will be a feasibility study that aims to show that social cognition training in HD can be studied in preparation for a larger randomized controlled trial. The investigators hypothesize that social cognition training can improve social cognition, social functioning, and quality of life in individuals with Huntington's Disease and decrease caregiver burden among those who care for individuals with Huntington's Disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Nov 2025

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress18%
Nov 2025Jul 2028

First Submitted

Initial submission to the registry

February 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2028

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

February 11, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

Huntington's DiseaseSocial CognitionCaregiver Burden

Outcome Measures

Primary Outcomes (4)

  • Proportion of participants willing to consider study out of those who have been approached

    32 months

  • Number of participants who adhered and completed the study

    32 months

  • Ease of program on a scale of 1 to 5 with 5 being "very easy."

    32 months

  • Participant satisfaction with the program

    This will be a qualitative measure. The study staff will elicit from the participants what they liked about the program, what they did not like about the program, and what they would change about the program if they could.

    32 months

Secondary Outcomes (6)

  • Change in accuracy on a facial emotion recognition task

    6-12 weeks

  • Change in accuracy on an empathic accuracy task

    6-12 weeks

  • Change in score on the Quality of Life in Neurological Disorders Ability to Participate in Social Roles and Activities (scores range from 45 to 225; higher score indicates better outcome)

    6-12 weeks

  • Change in score on the Quality of Life in Neurological Disorders Satisfaction with Social Roles and Activities Questionnaire (scores range from 45 to 225; higher score indicates better outcome)

    6-12 weeks

  • Change in score on the Quality of Life in Neurological Disorders Positive Affect and Wellbeing Questionnaire (scores range from 23 to 115; higher score indicates better outcome)

    6-12 weeks

  • +1 more secondary outcomes

Study Arms (1)

Social Cognition Training Group

EXPERIMENTAL
Behavioral: Social Cognition Training

Interventions

Neuroplasticity-based social cognition training that targets a range of social cognition skills, including visual and vocal affect perception, social cue perception, theory of mind, self-referential style, and empathy

Social Cognition Training Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Huntington's Disease based on genetic testing
  • Must be between 18 and 65 years of age
  • Native English speaker who is literate in English
  • Stable psychotropic medication regimen for 4 weeks
  • Must have a score of "somewhat easily" on all items in the CPQ-12
  • MOCA \>18
  • Completed 12 years of schooling
  • Access to laptop or mobile device
  • Willingness to come in person 6-12 weeks after first visit
  • Lives with patient
  • Must be between 18 and 65 years of age
  • Native English speaker who is literate in English
  • MOCA \>26
  • Willingness to come in person within 6-12 weeks after first visit

You may not qualify if:

  • Any known neurological condition (other than Huntington's Disease).
  • History of learning and/or intellectual disabilities
  • Currently actively involved in any other interventional trial (i.e. have begun the intervention) or within 4 weeks of completing the final assessments of an interventional trial.
  • Currently regularly completing a computerized cognitive training intervention.
  • Active suicidal ideation with some intent
  • Inability to provide informed consent
  • Active suicidal ideation with some intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Neurological Sciences and Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 14, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

July 15, 2028

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations