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OpenTrials
Completed

NCT Number: NCT02736396

Southend Imaging Study

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Southend Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

fMRI

Other

Functional MRI scan to be performed

neuropsychological tests

Other

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

Primary outcomes

  1. Evaluation of the functional connectivity in the Default Mode Network .

    Time frame: 4 years

    Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.

Secondary outcomes

  1. Correlation of cognitive performance to functional connectivity.

    Time frame: 4 years

    To evaluate the correlation between individual measures of functional connectivity and global and episodic cognitive performance as measured by neuropsychological tests.

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Collaborators

  • Anglia Ruskin University

Registry information

Acronym: SIS

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 13, 2016
Registry last updated
Dec 22, 2020

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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