AzTrials
AzTrials

Intracranial PressureNCT03144297

Intracranial Pressure vs Percentage Body Fat

An observational study of Intracranial Pressure, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: It has already been established that there is a weak positive relationship between increased intracranial pressure (ICP), as measured by lumbar puncture manometry, and increased Body Mass Index (BMI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Pressure
What is being tested?
Lumbar puncture and BOD POD (air-displacement plethysmography)
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2015to Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Subjects recruited from general neurology clinic

Who may be able to join

  • Able to give informed consent

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Benjamin Wakerley

    Gloucester, Gloucestershire, GL13NN

Other trials in United Kingdom

About this study

Official title: Correlation Between Intracranial Pressure as Measured by Lumbar Puncture Manometry and Percentage Body Fat as Measured by Air-displacement Plethysmography

Background: It has already been established that there is a weak positive relationship between increased intracranial pressure (ICP), as measured by lumbar puncture manometry, and increased Body Mass Index (BMI). This is also observed clinically in some patients with idiopathic intracranial hypertension, who typically have raised BMI. The relationship between BMI and percentage body fat is non-linear, especially at BMI > 40. The Bod Pod device enables non-invasive body composition profiling, including accurate calculation of percentage body fat, without the use of radiation.

Aim: To examine the relationship between intracranial pressure as measured by lumbar puncture manometry and percentage body fat as measured by air-displacement plethysmography (Bod Pod)

Methods: 100 patients undergoing routine diagnostic and therapeutic lumbar punctures for a variety of non-emergency neurological conditions will be recruited. Cerebrospinal fluid opening pressure will be measured using standard manometry techniques. Blood pressure, height, weight, collar size, waist size and hip size will be measured. Body composition profiling will be carried out using the Bod Pod.

Read the detailed description

Patients due to attend the elective lumbar puncture clinic will be contacted by letter beforehand (at least a week) and provided with an information sheet about the this study. Neurology patients are referred to the lumbar puncture clinic as part of their diagnostic work-up. The clinic takes place every Friday on the neurology ward and is run by the MS nurse consultant who does the procedure.

Patients agreeing to take part in the study will have a lumbar puncture as normal. Before removing a small volume of spinal fluid (cerebrospinal fluid or CSF), the investigators routinely measure spinal fluid pressure using a manometer (pressure gauge). This is important because it indirectly tells us what the pressure is within the brain (intracranial pressure or ICP). Samples of CSF and blood may be needed as part of NHS patient care, but no additional samples will be needed for this study. The investigators will, however, take some additional measurements during the visit, which won't take more than an extra 5 minutes. These will include: weight and height; measures of neck, waist and hip circumference, using a standard measuring tape; and blood pressure before and after the lumbar puncture. The whole visit will be 45-60 minutes.

Patients agreeing to have body composition assessment in the Bod Pod device will be scheduled for assessment at the School of Sport Sciences at the University of Gloucestershire (Oxstalls campus) in the two weeks following lumbar puncture. The investigators will also contact patients prior to the appointment to confirm this. The university is a five minute drive from the hospital and can easily be accessed by public transport. Temporary parking permits for use in the university car park will be provided where necessary. At the university body composition will be assessed in the Bod Pod device by one of the trained technicians. The device consists of a small enclosed chamber, in which the patient sits. Changes in air volume allow calculation of body density and percentage body fat. For the test, patients will need to bring some form of tight-fitting swimwear (Speedos or underpants for men; swimming costumes for women, no bikinis). They will also be required to wear a swimming hat (which will be provided). No metal objects should be worn while in the Bod Pod. Prior to the test we may need to measure lung volume by asking the patient to blow into a spirometer. This helps to calculate body density but is not always necessary. The patient will then sit inside the Bod Pod (which is confined but non-invasive and has a large window in the front hatch and a panic button if they want to alert the technician) for about 3 minutes. During this time air displacement measurements are made and some people may experience slight pressure in their ears, although this is not dangerous. Male and female changing facilities are available and Bod Pod testing will be in a private, screened-off area with only the technician present. Patients can also ask for a chaperone or male/female technician if they prefer. This test will take about 15 minutes to complete and patients will be given computer readout of their body composition.

A power calculation for the study indicates that approximately 100 patients will need to be recruited. The investigators aim to recruit between 1 and 3 patients from the lumbar puncture clinic per week and therefore predict that the study will be completed within 2 years.

Being tested
Lumbar puncture, BOD POD (air-displacement plethysmography)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar punctureOther

    diagnostic lumbar puncture

  • BOD POD (air-displacement plethysmography)Other

    Assessment of body fat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial pressure vs % body fat using BodPOD

    Correlation between intracranial pressure as measured by lumbar puncture manometry and percentage body fat as measured by air-displacement plethysmography.

    Measured: 3 years

Secondary outcomes (1)
  1. intracranial pressure vs body mass index

    Correlation between intracranial pressure as measured by lumbar puncture manometry and body mass index.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study startMar 2015
  3. Primary completionJan 2020
  4. Study completionJan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144297
Sponsor's protocol ID
14/LO/2266
Status last verified
Mar 2026
First submitted
3 May 2017
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Pressure, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial pressure vs % body fat using BodPOD (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in