Viewing Study NCT04570215



Ignite Creation Date: 2024-05-06 @ 3:16 PM
Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04570215
Status: RECRUITING
Last Update Posted: 2023-08-09
First Post: 2020-05-29

Brief Title: Digital Interventions in Neuro-Rehabilitation Gotcha
Sponsor: University College London
Organization: University College London

Study Overview

Official Title: Digital Interventions in Neuro-Rehabilitation A Small Scale Randomised Clinical Trial to Test a Web-based Therapy Application for People With Naming Difficulties With Mild- Moderate Dementia Gotcha
Status: RECRUITING
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 cant remember their name
Have a diagnosis of dementia Alzheimers 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 Alzheimers 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
Detailed Description: 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 Alzheimers disease AD report forgetting even very familiar peoples names which patients find annoying and embarrassing Werner 2004 This therapy speaks to the James Lind Alliances 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 Alzheimers 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 andor 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 Objectives

The investigators aim to show that using this DNI will improve word retrieval on trained items by providing a known therapy used by SLTs 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 eg sustained attention
Does the DNI improve participants 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 healthwell-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 participants brain areas that change in response to the DNI

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None