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Clinical Trials/NCT04451213
NCT04451213CompletedNot Applicable

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

Cardiff and Vale University Health Board1 site in 1 country15 target enrollmentStarted: August 23, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Objective memory scores

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
35 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Objective memory scores

Time Frame: up to one year

Secondary Outcomes

  • MRI head(up to one year)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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