Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

August 30, 2023 updated by: Cardiff and Vale University Health Board
CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with CF have several potential risk factors which may predispose them to memory problems. Because the CF population has historically only been young, this is not something that has been focused on. No research has currently identified whether patients with CF have a much earlier risk of developing cognitive impairment or how CF impacts on the brain.

There has not previously been work in this area of CF and the investigators are in a unique position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on patients with CF for the first time.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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
      • Cardiff, United Kingdom
        • Cardiff and Vale University Health Board

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

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or Female, aged greater or equal to 30 years

    • A diagnosis of CF
    • Primary school education or above
    • Able to provide informed consent

Exclusion Criteria:

  • Contraindications to MRI as found on the CUBRIC screening form (including presence of indwelling metal devices/clips)

    • Existing neurological disease affecting cognition (including stroke and traumatic brain injury)
    • Existing diagnosis of dementia documented in medical notes
    • Vascular complications of diabetes
    • Requiring supplemental oxygen -long term or overnight
    • Hepatic failure
    • Overt psychiatric disorders
    • Past or present alcohol or recreational drug misuse
    • Pregnancy
    • Current infection Smoker

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
Diagnostic test: MRI head
MRI head

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective memory scores
Time Frame: up to one year
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI head
Time Frame: up to one year
the investigators will acquire structural and functional MRI data at 3T to explore brain health of CF patients compared to control data. Structural MRI will include T1 and T2 weighted anatomical images for group comparisons of brain morphology (volume, cortical thickness). T1 weighted images will also be used as reference images for all other MRI parameters.
up to one year

Collaborators and Investigators

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

Sponsor

Cardiff and Vale University Health Board

Collaborators

Cardiff University

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 (Actual)

August 23, 2021

Primary Completion (Actual)

December 23, 2022

Study Completion (Actual)

December 23, 2022

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/MAR/7625

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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