Skip to main content
OpenTrials
Completed

NCT Number: NCT03070821

Therapy of Alzheimer's Disease With Neurofeedback

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Dementia (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Elderly Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

rtfMRI neurofeedback training

Other

Information about the state of brain activation was given to subjects. That information was visualised as a thermometer bar. Subjects tried to modulate that activation while performing a mental imagery task.

3T MRI

Device

A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.

Primary outcomes

  1. Visual and Verbal Memory Test (VVM)

    Time frame: 2.5 weeks

    Neuropsychological assessment including visuo-spatial memory

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: 2.5 weeks

    Neuropsychological instrument for a general cognitive screening

  2. Wechsler Memory Scale Revised (WMS-R)

    Time frame: 2.5 weeks

    Subtests from the WMS-R were used to assess several domains of memory

  3. Trail Making Test (TMT)

    Time frame: 2.5 weeks

    TMT-A and -B were used to assess cognitive processing speed and task switching capabilities.

  4. Visual Patterns Test (VPT)

    Time frame: 2.5 weeks

    The VPT was used to assess visual working memory capabilities.

  5. Parahippocampal activation

    Time frame: 2.5 weeks

    Activation of the parahippocampal gyrus during neurofeedback training as measured with fMRI

  6. Memory-related functional connectivity using Granger Causality Analysis (GCA)

    Time frame: 2.5 weeks

    Change of functional connectivity mainly between memory-associated brain regions over the course of neurofeedback training characterised by GCA

  7. Change of brain structure

    Time frame: 2.5 weeks

    Assessment of grey matter volume in the entire brain

  8. Change of brain function

    Time frame: 2.5 weeks

    Assessment of activation in the entire brain

Sponsors and collaborators

Lead sponsor

University Hospital, Aachen

Other

Collaborators

  • Alzheimer Forschung Initiative e.V.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2017
Registry last updated
Mar 6, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.