Intracranial Pressure vs Percentage Body Fat

March 23, 2026 updated by: Gloucestershire Hospitals NHS Foundation Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL13NN
        • Benjamin Wakerley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects recruited from general neurology clinic

Description

Inclusion Criteria:

  • Able to give informed consent

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intracranial pressure vs % body fat using BodPOD
Time Frame: 3 years
Correlation between intracranial pressure as measured by lumbar puncture manometry and percentage body fat as measured by air-displacement plethysmography.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
intracranial pressure vs body mass index
Time Frame: 3 years
Correlation between intracranial pressure as measured by lumbar puncture manometry and body mass index.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gloucestershire Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14/LO/2266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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