Therapy of Alzheimer's Disease With Neurofeedback

February 28, 2017 updated by: Kathrin Reetz, University Hospital, Aachen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy elderly experimental group
Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI).
Other: rtfMRI neurofeedback training
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.
Device: 3T MRI
A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.
Experimental: Patient group
Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI).
Other: rtfMRI neurofeedback training
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.
Device: 3T MRI
A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.
Sham Comparator: Healthy elderly sham-feedback group
Feedback of the postcentral gyrus using rtfMRI neurofeedback training (using 3T MRI).
Other: rtfMRI neurofeedback training
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.
Device: 3T MRI
A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual and Verbal Memory Test (VVM)
Time Frame: 2.5 weeks
Neuropsychological assessment including visuo-spatial memory
2.5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: 2.5 weeks
Neuropsychological instrument for a general cognitive screening
2.5 weeks
Wechsler Memory Scale Revised (WMS-R)
Time Frame: 2.5 weeks
Subtests from the WMS-R were used to assess several domains of memory
2.5 weeks
Trail Making Test (TMT)
Time Frame: 2.5 weeks
TMT-A and -B were used to assess cognitive processing speed and task switching capabilities.
2.5 weeks
Visual Patterns Test (VPT)
Time Frame: 2.5 weeks
The VPT was used to assess visual working memory capabilities.
2.5 weeks
Parahippocampal activation
Time Frame: 2.5 weeks
Activation of the parahippocampal gyrus during neurofeedback training as measured with fMRI
2.5 weeks
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
2.5 weeks
Change of brain structure
Time Frame: 2.5 weeks
Assessment of grey matter volume in the entire brain
2.5 weeks
Change of brain function
Time Frame: 2.5 weeks
Assessment of activation in the entire brain
2.5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Aachen

Collaborators

Alzheimer Forschung Initiative e.V.

Investigators

  • Principal Investigator: Kathrin Reetz, Prof. Dr., University Hospital, Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2013

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFI 13812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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