Digital Interventions in Neuro-Rehabilitation: Gotcha!
Digital Interventions in Neuro-Rehabilitation: Gotcha!
Aims and background Everyone forgets the names of people they should know at times. Having
 dementia makes this problem worse. People with dementia have told expressed they forget the
 names of people they care about and this can be upsetting and embarrassing.

 However, evidence shows that if people get enough practice, they can re-learn these names.
 The investigators, along with people with dementia and their carers, have created a fun
 therapy for people to get lots of practice so they can remember the names of people that are
 important to them.

 The main aim of the study is:

 To prove that Gotcha! therapy can help people with dementia to improve their ability to
 remember names.

 Another aim is:

 To find out if using the therapy is related to any changes in the brains of people with
 dementia.

 Design and methods Participants are provided with a computer tablet to practise at home.
 Participants are required to think of 6-10 familiar people (family and friends) whose names
 they forget and want to remember better.

 Participants also need to practise every day for about 30 minutes over a 6 week period so
 they get a large amount of therapy.

 Participants will have 7 testing appointments over 12 months. At three of these appointments
 participants will need to have a brain scan. These scans are carried out by trained
 University College London professionals and will take no longer than 30 minutes each.

 For the appointments where participants do not need to have a brain scan home testing can be
 arranged.

 The investigators organise and pay for all journeys to and from University College London.

 Participants

 Participants can get involved in our research if they:

 -  Have ever experiences seeing a familiar person but can't remember their name

 -  Have a diagnosis of dementia (Alzheimer's disease or mixed dementia).

 -  Want to be part of an important and exciting research journey. Unfortunately a diagnosis
 of other any other types of dementia not mentioned above is not suitable for this study

 Patient and Public involvement The investigators have engaged with people from the
 Alzheimer's Society and local dementia carers groups, run many focus groups and interviewed
 people with dementia and their carers to co-design the therapy.

 At the end of our research participants are invited to University College London to learn
 about the results of the study.
Background

 The number of people with dementia in the UK is forecast to increase by 40% over the next 12
 years and 156% over the next 38 years (Prince et al., 2014). People with all stages of
 Alzheimer's disease (AD) report forgetting even very familiar people's names, which patients
 find annoying and embarrassing (Werner, 2004). This therapy speaks to the James Lind
 Alliance's dementia top priority, "What are the most effective components of care that keep a
 person with dementia as independent as they can be at all stages of the disease in all care
 settings?" Several case studies and one group study have shown that patients with AD can
 significantly improve proper name recall with training; the effects last months after
 training is completed (Clare et al., 2002). Given the prevalence of mobile phone technology
 with inbuilt cameras and the rapid rise in usage in the 64-74 year old bracket, the
 investigators will develop a name-training intervention that allows people with proper name
 recall impairments to take pictures of and add the name of people that they wish to name. The
 app will include voice recognition software so that our bespoke adaptive algorithm (developed
 with Prof Mark Huckvale at UCL) will be able to adaptively cue users depending on their
 speech output.

 Gotcha! will provide an app-based therapy for people with dementia who have difficulty naming
 people they know well.

 This Digital Neuro Intervention (DNI) will provide the opportunity for the necessary
 increased rehabilitation to help people recover lost naming function. This will alleviate NHS
 Speech and Language Therapist (SALT) time and put users in control of when and where they
 carry out practice-based language therapy.

 Identification and description of the Investigational Device

 Purpose Gotcha! will provide an app-based therapy for people with dementia who have
 difficulty naming people they know well.

 What does it do? The therapy element works via mass practice and feedback to the users on a
 trial-by-trial basis. The DNI is very simple in a way; it just presents a long series of
 pictures for users to name. This DNI will use speech recognition (SR) software in order to
 make a binary decision as to whether the user said the correct word or not. This affects what
 the next trial (object to name) is and what auditory cue (if any) is provided the next time
 the user has to name the same item.

 *The speech will be recorded on the device but no other identifiable information will be
 stored on it. When the participant finishes the trial, the investigators will delete all
 information on the device.

 What is the clinical trial design? A small, well-defined sample of patients with the
 potential to benefit from the DNI will be recruited. The main outcome measure is whether the
 DNI is effective at improving naming impairments. This comparison is within-subject and is
 achieved by comparing post-therapy measures to multiple baseline measures. The investigators
 are also comparing two different versions of the therapy (a between group comparison) to
 answer our secondary question of whether the therapy can be optimised. Outcome measures will
 be collected by the research team using a variety of standardized and non-standardized tests
 of language and cognition.

 The DNI will be introduced to the participant when attending a testing session. One of the
 research team will explain how to use the DNI, provide instructions for the user, and give
 some time for practice items. When confident that the participant can use the DNI
 independently, the participant will take the device home and continue their therapy
 (suggested therapy time is 5-10 hours per week) which will be simultaneously monitored by the
 research team. The research team will also check in on the participant weekly to trouble
 shoot any difficulties they may have (whether motivational or technical). When the
 participant has completed the therapy block, the investigators will invite them in again for
 testing and they will return the mobile device with the DNI on it. The participants who
 continue to receive standard care during the therapy block will be asked to record and submit
 details to the research team.

 Justification for the design of the clinical investigation Why is the research considered
 worth doing? Standard (face to face) Speech and Language Therapy (SALT) has a huge
 evidence-base but patients in the NHS have unmet therapy needs due to a lack of resources.
 The evidence from speech-therapy highlights the amount of time-on-task required to improve
 patients' ability to communicate. Naming problems are common and impact on the patients'
 wellbeing and social inclusion. There is also good evidence that current existing therapeutic
 approaches work.

 In the NHS a patient with Alzheimer's Dementia are likely to receive little or no SALT. Our
 solution to the lack of available SALT therapy is to produce digital neuro-interventions that
 give patients the opportunity to practice scientifically validated, impairment based therapy
 when and where it suits them which gives them access to optimum therapy dose.

 Therapy can be effortful for patients who can sometimes be too fatigued when the therapist
 comes to do their session. This digital neuro-intervention will provide optimum availability
 of therapy and therefore place the patient in control of how much they do. However, the
 therapy will be engaging through adaptive and exciting software. The adaptiveness will serve
 to reward the patients for their efforts without ever making them feel like they are failing.
 This will hopefully boost how long they spend in therapy and therefore make greater gains.

 There are therapy apps available for patients but the scientific basis for them is lacking
 and none are targeted for proper name anomia. By using speech recognition software our
 intervention will be uniquely designed to be used by patients with word retrieval
 impairments.

 What new information will the research provide? The concept of the therapy component is based
 on standard SALT practice and thus has a strong proof of concept basis, as do our proposed
 outcome measures. The novel component is packaging it in a user- friendly web-app that is
 designed for and by people with word-retrieval problems. The investigators will test the
 efficacy in a randomized-controlled trial (Phase 2). These digital neuro-interventions will
 be in contrast to the plethora of apps available online claiming cognitive training without
 having scientific proof.

 The Gotcha! research study is a small-scale, randomised clinical trial for participants with
 mild to moderate dementia who have difficulty naming the people they know well (proper name
 anomia). The main research question is whether Gotcha! therapy improves participants' ability
 to freely name the people they know well. will test this hypothesis by assessing
 participants' naming abilities on two matched lists of people, half are trained and half
 remain untrained.

 A secondary question relates to maintenance of therapy gains, to test this hypothesis two
 different versions of Gotcha! are compared, 'standard Gotcha!' and 'Gotcha! Maintenance'.
 These two versions are identical for the first block of therapy but differ thereafter in that
 the maintenance version continues to top up participants with brief training sessions over
 the next block while those in the standard group do not have any further interactions with
 the therapy. Participants will be randomised (using minimisation) to one of the two versions
 of the therapy. The main outcome measure will be a clinically relevant improvement on the
 naming ability of the trained items (compared to untrained control items). Secondary outcomes
 will include improvements in social activity and participation and participant and/or carer
 reported outcome measures (PROMS).

 The investigators also plan to capture brain-based data (functional and structural MRI and
 MEG) in order to test a series of secondary hypotheses relating to both how and why the
 therapy may work in some participants but not others. All brain imaging will be outside of
 standard care for the participants and take place at UCL by trained staff.

 Hypotheses and Objectives

 H1-Primary:

 Does Gotcha! improve naming performance on trained items?

 This is a within-subject comparison. The criteria for success is a 10% (raw, or
 unstandardized) relative improvement in performance. This effect size was used in the recent
 Big Cactus study.

 H2-Secondary:

 Does Gotcha! maintenance keep participants at their maximum achieved level compared to
 standard Gotcha?

 This is two factor analysis with both a within-subject factor (trained vs. untrained items)
 and a between-group factor (Gotcha! maintenance vs. standard Gotcha). The criteria for
 success is a 10% (raw, or unstandardized) relative difference in performance. This effect
 size was used in the recent Big Cactus study.

 Primary Objective Does Gotcha! improve naming performance on trained items?

 Secondary Objective(s)

 The investigators aim to show that using this DNI will improve word retrieval on trained
 items by providing a known therapy used by SLT's through a digital app and by enabling an
 increased dose of therapy. However, the investigators also believe that by using this DNI and
 practicing every day, there will be changes in participants' brain structure and in the
 health of the participants and their carers.

 -  Does Gotcha! maintenance keep participants at their maximum achieved level compared to
 standard Gotcha?

 -  Are the therapy effects item-specific or do is there generalization to untrained items?

 -  Are the effects of the DNI therapy limited to the language domain alone or do they
 improve in other cognitive domains (e.g. sustained attention)?

 -  Does the DNI improve participant's social activity and participation?

 -  Is the DNI acceptable to participants (can they use it easily)?

 -  Is the DNI acceptable to participants' carers?

 -  Does the DNI improve carer health/well-being?

 -  Does the DNI have any economic benefits?

 -  Can baseline structural brain imaging explain participants' responses to the DNI?

 -  Can baseline structural brain imaging be used to predict incoming participants' response
 to the DNI?

 -  Can repeated-measures structural or functional brain imaging identify participant's
 brain areas that change in response to the DNI?
Inclusion Criteria:

 -  Person with mild/moderate dementia

 -  Self-reported proper naming difficulty which we will then assess at Time Point 1
 English as their dominant language

 -  Able to tolerate MRI brain scan

 -  Able to give informed consent

 -  Able to use the DNI (app)

 Exclusion Criteria:

 -  No diagnosis of developmental language disorders

 -  No diagnosis of severe dementia or primary progressive aphasia

 -  No major co-existing neurological or psychiatric diagnosis

 -  No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or
 other metallic or electronic objects in the body, weight over 24 stone, claustrophobia
 or pregnancy).