Trial · NCT02990676
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants able to complete the feasibility study as measured by retention rate | 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. |
| Secondary | 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) | The cognitive training programmes completed will be assessed. The level of achievement and quality of the data generated will be assessed. |
| Secondary | Symbol digit modality test | 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. |
| Secondary | Stroop tasks on paper of colour and work naming | 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. |
| Secondary | Categorical verbal fluency (letter and categorical fluency test) | 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. |
| Secondary | Trail making A and B tests | 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. |
| Secondary | Digit Span Forward subtest from Weschler's Adult Intelligence Scale (WAIS) | 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. |
| Secondary | 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. | 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. |
| Secondary | Tower of Hanoi | 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. |
| Secondary | Card sorting task of executive function | 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. |
| Secondary | Number of participants able to fully complete timed up and go (TUG) motor assessments as assessed by time taken to complete the task | 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. |
| Secondary | Participant scores in the 'money box test' | 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. |
| Secondary | MRI scanning results | 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. |
| Secondary | Participant scores on the Hospital Anxiety and Depression Scale (HADS) | During 3 year study (Baseline Assessment, During Intervention and Outcome Assessment) | This short scale will be used to screen for depression and anxiety symptoms. |
| Secondary | Participant scores on The International Physical Activity Questionnaire (IPAQ) | 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. |
| Secondary | Participant scores on HD-Pro-TriadTM Questionnaire | 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. |
| Secondary | Participant scores on the Life-Space Assessment | 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. |
| Other | Qualitative experiences of participants and nominated carers, friends or family members. | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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