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Completed

NCT Number: NCT04451213

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff and VAle University Health Board

Cardiff, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI Head

Diagnostic Test

MRI head

Primary outcomes

  1. Objective memory scores

    Time frame: up to one year

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Collaborators

  • Cardiff University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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