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Clinical Trials/NCT03070821
NCT03070821
Completed
Not Applicable

Neurofeedback and Follow-up With Real-time fMRI to Investigate Cognitive Function in Patients of Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD)

University Hospital, Aachen0 sites30 target enrollmentJanuary 30, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Dementia (AD)
Sponsor
University Hospital, Aachen
Enrollment
30
Primary Endpoint
Visual and Verbal Memory Test (VVM)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The project aims to investigate in patients of Alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive ability, as well as functional and structural measures of the brain.

Over the course of the study subjects will learn a real-world footpath. During neurofeedback training subjects are then asked to recall this footpath while simultaneously trying to modulate their own brain activation based on feedback. Feedback is given about the parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial memory, which is known to be affected early by Alzheimer's disease pathology.

Before and after the training cognitive ability is assessed using neuropsychological tests mainly measuring numerous domains of memory.

The investigators hypothesise that the training leads to an improvement of the trained cognitive domain, but also induces changes in brain structure and function.

Registry
clinicaltrials.gov
Start Date
January 30, 2013
End Date
June 30, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Aachen
Responsible Party
Principal Investigator
Principal Investigator

Kathrin Reetz

Head of Memory Clinic and/or Principal Investigator

University Hospital, Aachen

Eligibility Criteria

Inclusion Criteria

  • Native speakers of German
  • Naive to neurofeedback experiments
  • Ability to provide written informed consent

Exclusion Criteria

  • Metallic implants (MR-safety)
  • Neurological/psychiatric disease (except Alzheimer's disease in the patient group)
  • Use of psychoactive medication (expect medication for Alzheimer's disease)
  • Familiarity with the study site

Outcomes

Primary Outcomes

Visual and Verbal Memory Test (VVM)

Time Frame: 2.5 weeks

Neuropsychological assessment including visuo-spatial memory

Secondary Outcomes

  • Wechsler Memory Scale Revised (WMS-R)(2.5 weeks)
  • Montreal Cognitive Assessment (MoCA)(2.5 weeks)
  • Trail Making Test (TMT)(2.5 weeks)
  • Visual Patterns Test (VPT)(2.5 weeks)
  • Parahippocampal activation(2.5 weeks)
  • Memory-related functional connectivity using Granger Causality Analysis (GCA)(2.5 weeks)
  • Change of brain structure(2.5 weeks)
  • Change of brain function(2.5 weeks)

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