NCT02990676

Brief Summary

Cognitive impairments, especially deficits of executive function, have been well documented as a core and early feature in Huntington's disease (HD). Cognitive impairments can be considerably burdensome and devastating for people and families affected by HD. Computerised cognitive training interventions that focus on improving executive function present a potentially exciting non-pharmacological treatment option. Novel work conducted in mouse models of HD, has demonstrated that cognitive training, administered from an early stage in the disease, can improve motor performance at an older age, even in the absence of further training in the intervening time. This represents proof of principle in an animal model of HD that cognitive training can improve HD disease symptoms. Improvements associated with executive function training have also been reported in a clinical setting in a variety of neurodegenerative diseases. For example, cognitive training, can improve executive function as people age, and training specifically focused on tasks of executive function has been shown to improve both cognitive and motor outcomes in neurodegenerative diseases such as Parkinson's disease (PD) and Alzheimer's disease (AD). Therefore, this study is a feasibility study which aims to establish proof of principle for using computerised cognitive training in people with HD. The investigators propose to determine the feasibility, acceptability and gather preliminary evidence of the effectiveness of a cognitive training intervention programme, targeted for people with HD. The investigators will also aim to investigate the most appropriate outcome measures to use in this study and gather feedback on the cognitive training intervention. The investigators will also establish proof of concept via the study of brain structure and function, using MRI scanning techniques. The computerised cognitive training software and the associated outcome measures will be investigated, taking into account the views of people and families who are affected by HD. A randomised feasibility study of computerised cognitive training for people with HD will then be conducted. Participants who are randomised to the cognitive training intervention group will be asked to complete a cognitive training intervention utilising "HAPPYneuron" software. Participants in the intervention group will be asked to complete the cognitive training programme for a minimum of 30 minutes, 3 times a week for the 12 week study duration. Participants in the control group will not receive any cognitive training and will be asked to continue as normal, however they will have home visits to control for the confounding effect of social interaction. Additional monitoring and prompting for the intervention group, will be conducted via email, text or telephone reminders (as preferred by the participant) and home visits. The motor and cognitive function of participants will be assessed at the beginning and end of the study, using a range of motor and cognitive assessments. Additional cognitive measurements will be recorded as part of the HAPPYneuron programme throughout the cognitive training intervention, such as accuracy and response time measures of particular computer games. MRI scans (optional) will be conducted at the beginning and end of the study to identify any structural changes in the brain that may be associated with the cognitive training intervention. As part of the feasibility and acceptability assessment, participants, family members and carers will be invited to complete a semi-structured interview at the end of the study, if consent is obtained, focusing on using this type of software as a home based therapeutic intervention.

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 Jan 2017

Typical duration 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

First Submitted

Initial submission to the registry

September 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

September 30, 2016

Last Update Submit

May 9, 2019

Conditions

Huntington's Disease

Keywords

CognitionComputerised cognitive trainingFeasibility studyHuntington's diseaseTranslational

Outcome Measures

Primary Outcomes (1)

  • Number of participants able to complete the feasibility study as measured by retention rate

    The primary outcome measure of this study is feasibility for this patient group, a retention rate of 75% will be considered feasible.

    During 3 year study (Outcome Measure)

Secondary Outcomes (16)

  • Number of participants able to complete computerised HAPPYneuron pro cognitive training as assessed by task performance and the quality of the data generated.

    During 3 year study (Outcome Measure)

  • Symbol digit modality test

    During 3 year study (Baseline Assessment and Outcome Assessment)

  • Stroop tasks on paper of colour and work naming

    During 3 year study (Baseline Assessment and Outcome Assessment)

  • Categorical verbal fluency (letter and categorical fluency test)

    During 3 year study (Baseline Assessment and Outcome Assessment)

  • Trail making A and B tests

    During 3 year study (Baseline Assessment and Outcome Assessment)

  • +11 more secondary outcomes

Other Outcomes (1)

  • Qualitative experiences of participants and nominated carers, friends or family members.

    During 3 year study (Baseline Assessment and Outcome Assessment)

Study Arms (2)

Computerised cognitive training group

EXPERIMENTAL

Participants will be asked to complete the training programme provided using HAPPYneuron software for a minimum of 30 minutes 3 times a week for 12 weeks. The intervention will be completed in participant homes with the help of email or telephone reminders, as preferred.

Behavioral: Computerised cognitive training

Control group

NO INTERVENTION

Asked to continue as normal

Interventions

Computerised cognitive trainingBEHAVIORAL

Computerised cognitive training regime

Computerised cognitive training group

Eligibility Criteria

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

You may qualify if:

  • Confirmed HD diagnosis by genetic test.
  • Over 18 years of age.
  • Enrolled in the EHDN Registry/Enroll-HD study.
  • Stable medication regime 4 weeks prior to recruitment (and not anticipated to change medications during the study period).

You may not qualify if:

  • Inability to provide consent.
  • Any known neurological condition (other than HD).
  • Currently actively involved in any other interventional trial (i.e. have begun the intervention) or within four weeks of completing the final assessments of an interventional trial.
  • Currently regularly completing computerised brain training programme.
  • MRI contraindications (e.g. a pacemaker) as established using standard screening procedures (optional).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiff University

Cardiff, United Kingdom

Location

Related Publications (2)

  • Yhnell E, Furby H, Lowe RS, Brookes-Howell LC, Drew CJG, Playle R, Watson G, Metzler-Baddeley C, Rosser AE, Busse ME. A randomised feasibility study of computerised cognitive training as a therapeutic intervention for people with Huntington's disease (CogTrainHD). Pilot Feasibility Stud. 2020 Jun 19;6:88. doi: 10.1186/s40814-020-00623-z. eCollection 2020.

    PMID: 32577299DERIVED

  • Yhnell E, Furby H, Breen RS, Brookes-Howell LC, Drew CJG, Playle R, Watson G, Metzler-Baddeley C, Rosser AE, Busse ME. Exploring computerised cognitive training as a therapeutic intervention for people with Huntington's disease (CogTrainHD): protocol for a randomised feasibility study. Pilot Feasibility Stud. 2018 Feb 6;4:45. doi: 10.1186/s40814-018-0237-0. eCollection 2018.

    PMID: 29445514DERIVED

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 Design

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

Study Record Dates

First Submitted

September 30, 2016

First Posted

December 13, 2016

Study Start

January 25, 2017

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

No individual participant data will be made available.

Locations

GB(1)