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Information (volunteers)

We are looking for several types of people to help us test this new device. On this page you will find the information for healthy volunteers. We will ask anaesthetists to be involved, and people who have had previous experience of spinal immobilisation. Please navigate to the relevant page to find the information on what you would be required to do.

What will I have to do as a healthy volunteer?

THIS PART OF THE STUDY IS NOW COMPLETE

You will be invited to a testing session which will be held at the Clinical Sciences Building at UHCW. This session will take place during the day, and will last approximately one hour. A member of the research team (clinician) will apply our new device and the two currently-used gold-standard devices for immobilising the cervical spine, in a random order. Whilst wearing each device we will measure how far you are able to move your head, open your mouth, and the pressure between the device and your body.

You will not need to wear anything unusual, just a thin shirt or t-shirt so that we can easily apply the devices, and you'll need to be prepared to lie on the floor for a while! (Also, female volunteers will be most comfortable wearing trousers, as one of the devices has straps that go around the legs). At the end of each application, we will ask you to complete a questionnaire giving your opinion on comfort and security of the device, and to make suggestions for improving the design of our new device.

THIS PART OF THE STUDY REQUIRES A FEW MORE VOLUNTEERS

We shall also ask you to come to a separate session (on an evening, or a weekend day) at Rugby St Cross hospital in order to have MRI scans whilst you are wearing each of the devices. This is because we have previously shown that the vertebrae and spinal cord are still able to move even if the head appears to be still in relation to the shoulders, and we wish to measure how much movement is possible with each of the devices. The scan session will last approximately two hours. You will find a copy of the UHCW MRI information leaflet below (please note that for this trial the MRI scans will not involve the use of any contrast agent), and another leaflet giving you specific information about the MRI that relates to this trial. Please see the dates given in the section below.

We are looking for 33 volunteers to test the prototype, the design of which has been approved for testing by the NHS research ethics committee and the MHRA.

Would you like to help with this study?

Below, you will find the Participant Information Sheets and copies of the consent form for the trial. If, after reading these documents, you are interested in helping us by taking part in the trial, please would you complete the indication of interest form here. We will then make contact with you to discuss your involvement further, and answer any questsions you may have. You will have a further opportunity to ask questions when you attend for the trial session. .

Date for remaining testing sessions

This will be at UHCW (Clinical Sciences Building)

THESE SESSIONS ARE NOW CONCLUDED

Inclusion and exclusion criteria for healthy volunteers:

Inclusion criterion:
A willingness to take part, and give up a few hours of your time.

Exclusion criteria:
A known neck problem or history of neck surgery, injury to the neck within the previous 12 months, any condition resulting in restriction of neck movement, if you know that you suffer from claustrophobia, or if you have metallic implants, an implantable cardioverter-defibrillator or a pacemaker. We shall also exclude those who are, or may be, pregnant, due to the MRI scans.

Dates for remaining MRI sessions at Rugby St Cross Hospital:

Thursday 17th July at 6.15 pm

Sunday 10th August at 8.00, 10.00, 12.00, 14.00 and 16.00

One further date to be advised

If you are willing to help with these sessions, please email Rose Jarvis at rose dot jarvis at warwick dot ac dot uk

Healthy Volunteer Information Sheet (PDF Document)

Healthy Volunteer consent form (PDF Document)

MRI scan information leaflet (PDF Document) and information specific to this trial (PDF Document)

If you would lilke further information at any time, please email spine at warwick dot ac dot uk or call 02476 150491