SIS: Southend Imaging Study

Sponsor

Mid and South Essex NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02736396

Collaborator

Anglia Ruskin University (Other)

Enrollment

Location

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study objective is to correlate global cognition and episodic memory performance to resting state fMRI functional connectivity. This is a non-treatment, prospective, natural history data collection study in a cross-sectional cohort of patients with cognitive impairment.

Condition or Disease	Intervention/Treatment	Phase
Cognition Disorders	Other: fMRI Other: Neuropsychological tests

Detailed Description

At present, Magnetic Resonance Imaging (MRI) is widely used along with other tests to help diagnose dementia, however diagnosis still remains challenging. There is currently a focus on the usefulness of resting state functionalMRI (RS fMRI) as a way of establishing differences in functional connectivity between healthy subjects and those with various neurodegenerative disorders. Although the potential for RS fMRI to be used as a biomarker for neurological diseases looks promising, further research is needed, especially regarding validation of normal values and seed-based functional connectivity. Further research into this area will help to improve the ability to appropriately classify new subjects and ultimately allow use of RS functional connectivity as a biomarker. This is a nontreatment, prospective, natural history data collection that aims to analyse functional connectivity in a cohort of patients with suspected cognitive impairment. Correlation of global cognition and episodic memory performance to resting state fMRI functional connectivity will be evaluated. Patient population will include patients over the age of 18 with cognitive impairment and age and gender matched controls. Eligible patients will have to complete neuropsychological and clinical assessments and complete an fMRI scan prior to enrolment.Study duration is estimated at 4 years.

Study Design

Study Type:

Observational

Actual Enrollment :

37 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Southend Imaging Study

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Healthy Controls Medical History, Neuropsychological tests, clinical assessments, fMRI	Other: fMRI Functional MRI scan to be performed Other: Neuropsychological tests Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.
Cognitive impairment Medical History, Neuropsychological tests, clinical assessments, fMRI	Other: fMRI Functional MRI scan to be performed Other: Neuropsychological tests Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.

Arm

Intervention/Treatment

Healthy Controls

Medical History, Neuropsychological tests, clinical assessments, fMRI

Other: fMRI

Functional MRI scan to be performed

Other: Neuropsychological tests

Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.

Cognitive impairment

Medical History, Neuropsychological tests, clinical assessments, fMRI

Other: fMRI

Functional MRI scan to be performed

Other: Neuropsychological tests

Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.

Outcome Measures

Primary Outcome Measures

Evaluation of the functional connectivity in the Default Mode Network . [4 years]
Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.

Secondary Outcome Measures

Correlation of cognitive performance to functional connectivity. [4 years]
To evaluate the correlation between individual measures of functional connectivity and global and episodic cognitive performance as measured by neuropsychological tests.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Informed consent
Cognitive impairment
Age from 18 to 100 years
On stable medication for 1 month before the screening visit; on or off cholinesterase inhibitors
Fluency in English and adequate premorbid intellectual functioning

Exclusion Criteria:

Any contraindication to MRI scanning
Clinically significant psychiatric disorder (e.g. depression)
Current clinically significant illness that could confound the results of the study
History of alcohol or drug dependence or abuse
Current use of anticonvulsant or narcotic medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southend Hospital	Westcliff on Sea	Essex	United Kingdom	SS0 0RY

Sponsors and Collaborators

Mid and South Essex NHS Foundation Trust
Anglia Ruskin University

Investigators

Principal Investigator: Paula A Harman, BSc, Southend University Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mid and South Essex NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02736396

Other Study ID Numbers:

P0867

First Posted:

Apr 13, 2016

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Cognition Disorders

Study Results

No Results Posted as of Dec 22, 2020