NCT03144297

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

May 3, 2017

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

    3 years

Secondary Outcomes (1)

  • intracranial pressure vs body mass index

    3 years

Interventions

diagnostic lumbar puncture

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects recruited from general neurology clinic

You may qualify if:

  • Able to give informed consent

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benjamin Wakerley

Gloucester, Gloucestershire, GL13NN, United Kingdom

Location

MeSH Terms

Interventions

Spinal Puncture

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 8, 2017

Study Start

March 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations