Generating clinical evidence for a medical device to treat anxiety and depression


The Alpha-Stim Aid is a relatively
new device, albeit the technology has been around since 1981. It uses a tiny
level of electrical stimulation called microcurrent to help the brain produce
extra alpha waves. The alpha waves are synonymous with relaxation, alertness,
calmness. It’s also the only brainwave that goes down into the central nervous
system through the spinal cord. It also allows the brain to produce increased
serotonin, so it has effects not only on anxiety but on depression, pain, and
insomnia. It’s very easy to use, it’s completely safe. A patient can use it at
home and it presents a really viable alternative to the treatment options
that currently exist. In the UK market. I discovered the NIHR through a
Google search following a meeting with NICE in Manchester. The outcome of the
meeting with NICE was very positive but they did say we needed to set up a
research project specifically within the NHS. The NIHR stood out to me, and one of the NIHR centres was based in Nottingham, which is where I’m from. I
contacted them, I got a response from Professor Richard Morris saying ‘yes
this is something I’d really like to help with’. NIHR MindTech have done a
fantastic job in terms writing the protocol. Professor Richard Morris wrote
the protocol, and Jen Martin was also very instrumental in that. So the protocol was
written, we then went back to NIHR to discuss how we got that protocol
ready for ethics and that’s where NIHR Clinical research Network really came into their own. They
recommended suitable CROs to help facilitate pulling the whole thing together. The
CRO then worked with NIHR in terms of building the cost base and everything
that needed to be done to get the the research ready for ethics. And as
soon as the protocol was ready we then started the process of patient
recruitment with the with the research nurses. The challenges we faced,
certainly in the early days, were that we had three research nurses who were all very
familiar with the device, they all used the device, but we were effectively
trying to recruit blind because we had a waiting list of patients that we
approached with a letter of introduction and a brief protocol of what the study
was. And initially the research nurses found that they weren’t getting the kind
of uptake that they were expecting. So rather than get deflated, they
decided to try and approach things slightly differently. We had to rethink
about the letter based on the feedback they’ve been getting from
patients who had responded, we rewrote the letter- or rather they
rewrote the letter. And then we sent it out as a second batch and that had a far
more effective reach in terms of uptake. So that was one of the main
challenges, the initial uptake was very very slow. One of the other
challenges that the research nurses faced was we were up against it in terms
of timescales. We had a 120 patient target over six months, so 20 patients a
month, and that moved because obviously we had some dropouts. And as well and as the study evolved further challenges presented themselves – so we we increased
the target number. Every challenge that was faced was overcome with absolute gusto
by the research nurses. I cannot emphasise enough – they were so
enthusiastic about getting the study done, but getting it done
effectively. And they achieved what we all set out to do
in in the time scales which was remarkable considering the
start we had particularly, The study’s finished, the last patients details were
taken at the end of 2017 and the outcomes, the efficacy data is exactly as
we hoped it would be. We’ve just finished the health economics,
and that again is showing exactly what we hoped it would show- there are some significant cost savings to be made by the NHS. But I think
overall the experience for me has been a very positive one. Without the
support of MindTech and NIHR there’s no way the study would have got off the
ground. I’m a layman, it was the first time I’ve done something like this.
So we’ve got a great product but I don’t profess to have any of the
connections required to to do a research project… so they were absolutely
instrumental in getting the whole thing off the ground and
we’re now sat here today with the study being finished and and just about ready for
publication and that’s primarily down to those guys.

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