The film is being created to inform audiences about a research study examining the effects of Vagus Nerve Stimulation (VNS) therapy on people with Prader-Willi Syndrome. The film will include interviews with experts, participants in the initial pilot study, and their families. It will describe what is involved in the research, including surgery, tests, and potential side effects, to enhance viewers' ability to consent to future studies. The goal is to factually present the research and experiences, rather than promote VNS as a solution to PWS behaviors.

1. Film Brief
Prader-Willi Syndrome VNS Research Study

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Introduction
A short film is being created to complement the research study into the affects of Vagus Nerve
Stimulation therapy in people with Prader-Willi Syndrome. The film production is a collaboration
between the Department of Psychiatry and the Office of External Affairs and Communications at
the University of Cambridge. This short film brief defines the film’s objectives, describes the main
components of the film and outlines the milestones of the production. It is being shared among all
the stakeholders to keep them informed of the progress of the film production and to invite their
input into the production.
If you have any questions or comments, please contact:
Ajmal Sultany
Research Assistant
Department of Psychiatry
as2428@medschl.cam.ac.uk
Jonathan Settle
New Media Manager
Office of External Affairs and Communications
jonathan.settle@admin.cam.ac.uk

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Objective
The aim of this short film is to inform the target audience about the Vagus Nerve Stimulation
Therapy and how it is being applied by the department of Psychiatry at the University of
Cambridge as an innovative method to reduce the maladaptive behaviours affecting those with
Prader-Willi Syndrome.
The film will include the personal experiences of the three participants and their families, who
were involved in the initial pilot study. In the interviews, they will recall what they did as part of the
study and how they felt for the duration of the study.
The film should enhance the capacity of viewers with PWS to consent to participation in any future
study of a similar nature. In particular, the film seeks to detail exactly what is involved as part of
the proposed research study, including the use of surgery under general anaesthetic, various
research tests, and potential side effects.
The film will steer away from ‘selling’ the VNS procedure and the proposed research as a definite
solution to behaviour problems associated with PWS. Instead the aim of the film is to present
factual information about the research project and share the experiences of the participants
involved in the pilot.
Audience
The primary audience for this film are:
• Those affected with PWS
• Families of those affected with PWS
• Carers of those affected with PWS
• Scientific Community interested in PWS and VNS
• General public interested in PWS research
Narration
The film will have a voice over narration. The voice over narration (most likely Katie Manning) will
be talking directly to the audience in an informal tone. The Voice over narration should be spoken
clearly and in short sentences and will be narrated in first persons so that the narrator speaks to
those affected directly. For example saying:
"Thank you for choosing to watch this short film"…. Or…. "you are already familiar Prader-Willi
Syndrome but what you may not know is…"
The narration starts from the beginning accompanied with footage or images relevant to the PWS
VNS study. A great example of this can be seen here on the following University of Cambridge
film (http://www.youtube.com/watch?v=oGri4YNggoc).
The narration will start the film by telling the audience
• what is the purpose of the film,
• the importance of the study, and
• how the film can enable the audience to make an informed decision about whether they
want to participate in a future study.

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The narration will be scripted with support from Katie Manning.
Stakeholders
The film has a number of stakeholders and as such we will keep them in mind and credit them
wherever necessary. They are:
• University of Cambridge
• Department of Psychiatry
• Clinical Research Facility at Addenbrookes Hospital
• Foundation for Prader-Willi Research
• Prader-Willi Syndrome Association UK
• Cyberonics
• PWS VNS participants and families
Precedent
There is a precedent in creating films for research projects that are connected to CIDDRG. These
are:
“Defeating Dementia in Down’s Syndrome”
http://www.youtube.com/watch?v=jCNMxdie9oE&list=PL90WG75cvZ2A40OOxgUCUEnIhp-
ceHgEx
“The Scanner”
http://www.youtube.com/watch?v=ofgjtGra3I8&list=PL90WG75cvZ2A40OOxgUCUEnIhp-ceHgEx
We agreed that for the VNS PWS film, the aim is to create a film that is of a quality that falls
between these two. Furthermore, the film can borrow some ideas from the following NHS film
about PWS: http://www.nhs.uk/conditions/prader-willi-syndrome/Pages/Introduction.aspx. In
particular, the use film footage of people with PWS at their homes, interviews with experts and
families are aspects that can be adapted for the creation of our film.
Interviews
A number of interviews will be filmed and used as part of the film. These are:
• Expert interview with Professor Tony Holland discussing the behaviour issues related with
PWS and how this innovative VNS study can help to change negative behaviours.
• Expert interview with Katie Manning where she speaks about how much care and attention
goes into supporting the participant, carers and families from the start to the finish of the
research project.
• Expert interview with Stuart Fuller (CRF Nurse Manager) where he speaks about CRF, the
role of the nursing team and work that goes into ensuring the comfort of the participants.
• Expert interview with Mr Mathew Garnett (Addenbrooke’s Hospital) whilst he speaks about
the surgery and what is involved in the procedure. Matthew can re-enact what he will tell
the PWS participant upon arrival for screening. This short interview will give the viewers
the opportunity to become familiar with the surgeon and the surgery procedure which
should help in increasing their capacity to consent.

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• Expert interview with Chris Oliver (University of Birmingham) about his role in the research
study and the cognitive measures that will be used in the study.
• Interview with Susan Passmore (PWSA CEO) or Jackie Waters (Director of Services)
about the maladaptive behaviour problems usually associated with PWS. In particular,
statistics or anecdotal evidence (from the enquires the Association receive) can be
highlighted which demonstrate that behaviour issues (such as tantrums) are a major
problem for those with PWS and their families. The interview should be kept as neutral as
possible so that it is not seen as promoting the study.
• Interview with the three participants, where they speak about their experience of taking
part in the study and recall how they felt. With Katie (the participant that felt that she did
not benefit from the VNS), the focus should be how she benefited in other ways and not
necessarily from a eating/ weight loss perspective.
• Interview with one family member of each participant to add to the dimension the story. It
would be beneficial to the audience to know the families reasons for getting involved in the
study and what they experienced during the research phase.
Graphics and animation
The film will make use of high quality graphics wherever possible; this includes the introduction
and final credits. There is the potential of using incorporating some "tracked text" for any statistical
info, as per the “My Cambridge” (http://www.youtube.com/watch?v=PD0SZzzs0bI) film. High
standard graphics can be embedded within the PWS VNS film that will enhance the quality of the
film.
1. Animation
We decided that the film will have one core animation which will illustrate how the VNS will
operate, including the electric signal being generated and how the pulse travels to through the
vagus nerve (useful documents can be found here: http://us.cyberonics.com/support-
center/resource-library).
Based on a search of the web, I have found only the following animation of the VNS in operation:
http://www.youtube.com/watch?v=Z611H6nyB2U
The Cyberonics YouTube channel have the following ‘patient case study video’ which includes an
animation (see from 4 minutes):
http://www.youtube.com/watch?v=Ry426NOo1kM
Resources that describe the VNS for the general public:
http://www.epilepsysociety.org.uk/vagus-nerve-
stimulation?gclid=CIGx4djXr7wCFUT3wgodeRwApg#.Uu9m3nd_tS8
2. Touchstone Graphic
In particular, the film will feature a central ‘touchstone’ graphic that will connect all the steps
involved in the research procedure. Graphical presentation is used to make it easier for the

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viewer to see what exactly is involved in the study. There are 10 steps and they answer the
question: “What happens if I decide to take part in the study?”
These steps are:
1. “Receiving an Information Pack”
DESCRIPTION: Send identified participants information and resources.
2. “Expressing an interest in taking part ”
DESCRIPTION: Follow up with identified participants to check who is interested in
participating.
3. “Having a phone conversation”
DESCRIPTION: Those that indicate an interest will be screened via remote interview
(phone, Skype etc) to check their suitability for the study (for example, do they have sleep
apnoea).
4. “Home visit from the Research Team”
DESCRIPTION: Those that pass the screening, will be visited by the research team at
home who will answer any questions the participants may have.
-The research team will also enquire about the role and reliability of family and carers who
will act as ‘informants’, reporting and keeping a diary of the participants behaviour.
-The research team will use this opportunity to give the potential participants an example
of the behaviour diary to allow them to practice.
5. “Opportunity to visit Cambridge”
DESCRIPTION: The participants are then invited to Cambridge and admitted to the clinical
research facility (CRF) for further screening such as sleep apnea and have an opportunity
to meet the surgeon (Dr Matthew Garnett. This will help the participant better understand
the study and become more familiar with the procedure. Medical measures such as height/
weight/ blood sample/ saliva/ heart activity.
6. “We will ask you if you want to be part of the study”
DESCRIPTION: Formal Consent will be sought once the picture is very clear and
maximum capacity for consent is reached.
7. “You will undergo surgery”
DESCRIPTION: Next visit to Cambridge to have the stimulator surgically implanted.
8. “You will be given a period of rest”
DESCRIPTION: There will be a period of recovery post surgery.
9. “The VNS will be activated”
DESCRIPTION: Next visit to Cambridge is for the activation of the stimulation using the
‘Wand’.
10. “Research testing will begin”

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DESCRIPTION: From this point forward until the end of the research study, the
participants will be asked to visit Cambridge regularly to do the following:
-Keep a diary
-Participate in/ complete a number of interview schedules
-Take part in cognitive experiments
-Have two Functional MRI scans
3. Timeline diagram
The film will include a diagram which clearly demonstrates the randomised double blind crossover
nature of the study. The reason for including this diagram is so that the viewer understands what a
placebo or sham condition is and why it is important in a scientific study. The diagram will be
accompanied with a narration by Professor Tony Holland, where he explains each component.
The diagram (see diagram 2) is drafted by Ajmal and will be adapted for the film by the
Communications team.
Script and Verbal Storyboard
The script and Verbal Storyboard will act as the main reference text for the development of the
film and will be as in depth as possible to enable all stakeholders to be on the same page.
The script and verbal storyboard will be led by the Communication Team supported by Ajmal.
Film Footage
The film will contain a variety of footages that will support the narration and interview
conversations. The following footage should be captured:
1. Footage of Cambridge City and in particular the University of Cambridge
2. Footage of the Clinical Research Facility in Addenbrooke’s Hospital
3. Footage of Douglas House - Department of Psychiatry from outside
4. Participants at home where they carry out normal day to day activities
5. Participants going outdoors in their local community
6. Participants getting prepared to travel, then getting into vehicle, driving away
7. Participants arriving in Cambridge, being greeted by research team
8. Footage of the Clinical Research Facility (CRF)
9. Footage of Wolfson Brain Imaging Centre (WBIC)
10. Participants going through all procedure as they did during the pilot study
11. Footage of participants having the stimulation increased using the VNS ‘wand’ control in
clinical setting
12. Footage of VNS technology - that is footage of what is the VNS equipment and all its
components including the VNS pulse, Perennia lead, and the control wand.
Still Images
A variety of still images should be taken to be used as cut away images during voice over
narration and to accompany other voice aspects of the film (e.g., interview conversation). The
images should be similar to the range of film footages that are outlined above.

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A number of high quality images of people with PWS has been sourced from the PWSA UK. They
can be included in the film with the appropriate credits.
End product
10 minutes high quality factual film that is both informative and emotive, where PWS VNS
participants and their families share their experience of the research study and how it affected
them. This is then complemented by expert interviews where the proposed study is explained in
more detail and potential participants are reassured of the ethics, safety and professional care of
provided to them.
The film will be published online but provision should be made to create tangible copies that can
be distributed at events or talks for promotional purposes if the MRC funding is approved.
Film Production Timeline
The below timeline (diagram 1) outlines the milestones for the successful production of the film.

9. Diagram 1
Film Production Timeline

10. Diagram 2
Study Trial Timeline