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Therapy of Alzheimer's Disease With Neurofeedback

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ClinicalTrials.gov Identifier: NCT03070821
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Alzheimer Forschung Initiative e.V.
Information provided by (Responsible Party):
Kathrin Reetz, University Hospital, Aachen

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.


Condition or disease Intervention/treatment Phase
Alzheimer Dementia (AD) Elderly Other: rtfMRI neurofeedback training Device: 3T MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The design is a pre-test/post-test study with an intervention of three parallel groups. The groups are a healthy elderly experimental group, a patient group and a healthy elderly sham-feedback group.
Masking: Single (Participant)
Masking Description: Healthy subjects in the sham feedback condition were not aware of their group membership, but were debriefed at the end of the study.
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : January 30, 2013
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Visual and Verbal Memory Test (VVM) [ Time Frame: 2.5 weeks ]
    Neuropsychological assessment including visuo-spatial memory


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03070821


Sponsors and Collaborators
University Hospital, Aachen
Alzheimer Forschung Initiative e.V.
Investigators
Principal Investigator: Kathrin Reetz, Prof. Dr. University Hospital, Aachen

Responsible Party: Kathrin Reetz, Head of Memory Clinic and/or Principal Investigator, University Hospital, Aachen
ClinicalTrials.gov Identifier: NCT03070821     History of Changes
Other Study ID Numbers: AFI 13812
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathrin Reetz, University Hospital, Aachen:
neurofeedback
real-time functional MRI
parahippocampus

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders