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Developing a New EEG Method for the Early Diagnosis of Dementia

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ClinicalTrials.gov Identifier: NCT02426398
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
This is a non-invasive study investigating whether EEG, which is used in routine clinical care can be useful in diagnosing dementia. Novel in house developed software will analyse EEG data for this purpose from people with Alzheimer's disease and healthy volunteers.

Condition or disease
Dementia

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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Developing a New EEG Method for the Early Diagnosis of Dementia. Using Novel EEG Analyses to Create a Diagnostic Test and Biomarker for Use With People With Dementia
Study Start Date : March 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort
People with Alzheimer's disease
People with Alzheimer's disease
Healthy volunteers
Healthy volunteers



Primary Outcome Measures :
  1. Significant spatiotemporal measurements from EEG [ Time Frame: 12 months ]
    EEG data analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinical diagnosis of possible or probable AD (according to revised diagnostic criteria (McKhann et al., 2011, Dubois et al., 2007)
Criteria

Inclusion Criteria:

• Clinical diagnosis of possible or probable AD (according to revised diagnostic criteria (McKhann et al., 2011, Dubois et al., 2007)

Exclusion Criteria:

  • Significant vascular change on neuro-imaging (Fazekas grading of white matter change >2) (Fazekas et al., 2002).
  • Clinical history of stroke, Parkinsonism, epilepsy or other neurological disorder. (e.g. severe auditory, visual, language or motor impairment)
  • Moderate to severe dementia (defined by research team but we wouldn't expect those with a mini mental state exam [MMSE] ≤ 18 to be able to participate)
  • Severe current mental health disorder (depression, psychosis).
  • Patients on sedating or antiepileptic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426398


Contacts
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Contact: Daniel Blackburn, MBChB, PhD 01142222267 d.blackburn@shef.ac.uk
Contact: Jodie Keyworth j.keyworth@shef.ac.uk

Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Trust Recruiting
Sheffield, S Yorks, United Kingdom, S10 2HQ
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Daniel Blackburn, MBChB, PhD Sheffield Teaching Hospitals NHS Trust
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02426398    
Other Study ID Numbers: STH18419
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
EEG
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders