Exploring Computerised Cognitive Training for People With Huntington's Disease (CogTrainHD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02990676|
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : January 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Huntington's Disease||Behavioral: Computerised cognitive training||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Exploring Computerised Cognitive Training for People With Huntington's Disease|
|Actual Study Start Date :||January 25, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Computerised cognitive training group
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
Computerised cognitive training regime
No Intervention: Control group
Asked to continue as normal
- Number of participants able to complete the feasibility study as measured by retention rate [ Time Frame: During 3 year study (Outcome Measure) ]The primary outcome measure of this study is feasibility for this patient group, a retention rate of 75% will be considered feasible.
- Number of participants able to complete computerised HAPPYneuron pro cognitive training as assessed by task performance and the quality of the data generated. [ Time Frame: During 3 year study (Outcome Measure) ]The cognitive training programmes completed will be assessed. The level of achievement and quality of the data generated will be assessed.
- Symbol digit modality test [ Time Frame: During 3 year study (Baseline Assessment and Outcome Assessment) ]This is a simple substitution task to measure executive functioning. Using a reference key, the participant has 90 seconds to pair specific numbers with given geometric figures.
- Stroop tasks on paper of colour and work naming [ Time Frame: During 3 year study (Baseline Assessment and Outcome Assessment) ]In the stroop tasks, the participant is required to read words of colour names (e.g. red, blue) printed in black ink, and is asked to identify colours. This trial is intended to rule out colour blindness and ensure an adequate reading ability to complete the task. In the second stroop baseline trial, the subject must name the colour in which a word is presented, while ignoring the printed word. Thus, incongruence between the words colour and identity requires inhibition and response selection.
- Categorical verbal fluency (letter and categorical fluency test) [ Time Frame: During 3 year study (Baseline Assessment and Outcome Assessment) ]The fluency tasks require participants to verbally generate words beginning with a given letter (e.g. words beginning with the letter F) or category (e.g. animals). Participants are given one minute to retrieve as many words as possible and are instructed to avoid repetitions.
- Trail making A and B tests [ Time Frame: During 3 year study (Baseline Assessment and Outcome Assessment) ]This pencil and paper task uses randomly placed letters (and numbers for part B) as stimuli and participants must connect in sequence by drawing a continuous line with a pencil (e.g. from A-1-B-2-C-3 for part B). There is a brief sample for instruction purposes.
- Digit Span Forward subtest from Weschler's Adult Intelligence Scale (WAIS) [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This task of working memory involves the participant being read a sequence of numbers and is asked to recall the numbers in the same order.
- Dual-tasking. Subjects are required to switch their attention between two competing tasks. Subjects will be asked to cross out a series of boxes whilst simultaneously recalling a digit sequence. [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This test requires subjects to switch their attention between two competing tasks. Subjects will be asked to cross out a series of boxes whilst simultaneously recalling a digit sequence at a difficulty matched to their own digit span length.
- Tower of Hanoi [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]The Tower of Hanoi task has been used extensively as a test of planning ability in neuropsychological patients and normal populations to assess executive function. Participants are asked to preplan mentally a sequence of moves to match a start set of discs to a goal, and then to execute the moves one by one.
- Card sorting task of executive function [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This is a neuropsychological test of "set-shifting", i.e. an executive function that reflects mental flexibility in the face of changing schedules of reinforcement. It requires subjects to identify a rule (e.g. a commonality between cards) and sort cards into groups according to that rule.
- Number of participants able to fully complete timed up and go (TUG) motor assessments as assessed by time taken to complete the task [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]The Timed Up and Go Task (TUG) will be used to determine participant mobility and balance. The task will involve the participant rising from a seated position, walking 3 metres and returning to a seated position. A quantitative version of the task and a dual task will also be performed.
- Participant scores in the 'money box test' [ Time Frame: During 3 year study (Baseline Assessment and Outcome Assessment) ]The money box test has been developed as a dual task for use in HD to assess upper limb dexterity and motor function.
- MRI scanning results [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]The MRI scanning protocol will include scans to assess a structural scan to assess gross macrostructure, microstructural scans to assess white matter and myelination changes as well as quantitative fMRI to measure resting cerebral blood flow.
- Participant scores on the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This short scale will be used to screen for depression and anxiety symptoms.
- Participant scores on The International Physical Activity Questionnaire (IPAQ) [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This questionnaire assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening activities, work-related and transport-related activity.
- Participant scores on HD-Pro-TriadTM Questionnaire [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This is a reliable and valid health-related quality of life instrument that captures the typical triad of HD symptoms.
- Participant scores on the Life-Space Assessment [ Time Frame: During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) ]This tool can be used to establish the spatial extent of a person's mobility a useful outcome measure of independence.
- Qualitative experiences of participants and nominated carers, friends or family members. [ Time Frame: During 3 year study (Baseline Assessment and Outcome Assessment) ]Analysis will provide key words which will elicit general themes and attitudes to the cognitive training intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990676
|Contact: Emma Yhnell, PhD||02920 688456||YhnellE@cardiff.ac.uk|
|Cardiff, United Kingdom|
|Contact: Emma Yhnell YhnellE@cf.ac.uk|