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Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

MRI head

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cardiff and VAle University Health Board

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental

Arm Description

Outcomes

Primary Outcome Measures

Objective memory scores

Secondary Outcome Measures

MRI head

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.

Full Information

NCT ID

NCT04451213

First Posted

January 21, 2020

Last Updated

August 30, 2023

Sponsor

Cardiff and Vale University Health Board

Collaborators

Cardiff University

1. Study Identification

Unique Protocol Identification Number

NCT04451213

Brief Title

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

Official Title

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 23, 2021 (Actual)

Primary Completion Date

December 23, 2022 (Actual)

Study Completion Date

December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardiff and Vale University Health Board

Collaborators

Cardiff University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

experimental

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI head

Intervention Description

MRI head

Primary Outcome Measure Information:

Title

Objective memory scores

Time Frame

up to one year

Secondary Outcome Measure Information:

Title

MRI head

Description

Time Frame

up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Cardiff and VAle University Health Board

City

Cardiff

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

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