Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

Sponsors

Lead Sponsor: Cardiff and Vale University Health Board

Collaborator: Cardiff University

Source Cardiff and Vale University Health Board
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.

Overall Status Not yet recruiting
Start Date September 6, 2020
Completion Date December 5, 2021
Primary Completion Date December 5, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective memory scores up to one year
Secondary Outcome
Measure Time Frame
MRI head up to one year
Enrollment 15
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: MRI head

Description: MRI head

Arm Group Label: experimental

Eligibility

Criteria:

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

Gender: All

Minimum Age: 35 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

January 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: experimental

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov