Brain pulse project - Chiari Pilot version 1
Research type
Research Study
Full title
A pilot study to assess the practicality of non-invasive tympanic membrane displacement in a Chiari malformation patient population as a source of Intracranial Pressure Monitoring.
IRAS ID
59134
Contact name
AA Birch
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This study is pilot work, which aims to show a safe and painless novel method can be used to measure pressure pulsing inside the head in patients with Chiari malformations. This measurement has the potential to help diagnose Chiari malformations and quantify severity. The current study will give us baseline readings for future larger studies.
The method has been developed in Southampton, and is known as Tympanic Membrane Displacement (TMD). TMD measures small movements of the eardrum, believed to be caused by pressure pulses inside the head being transmitted through the ear. We are studying this method in patients with Chiari malformations, because they have brain CSF flow problems that may increase the pressure pulsing inside the head.
The study will be conducted by the department of Medical Physics and Bioengineering at the University Hospital Southampton NHS Foundation Trust. We will recruit 20 male or female participants aged 4-45years, 10 patients who are newly diagnosed with Chiari malformations and 10 volunteers.
Participants will be assessed on two occasions, before and after surgery for patients and one month apart for volunteers. On each occasion, we will take measurements with TMD, together with continuous blood pressure monitoring with a device and a respiratory chest strap or nasal air sampling to give us heartbeat and breathing timings respectively. We will measure subjects first in the sitting position, second supine and finally during a subtle bed tilting manoeuvre. The total duration of the measurements will be approximately one and a half hours.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
13/SC/0263
Date of REC Opinion
5 Aug 2013
REC opinion
Further Information Favourable Opinion