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Therapy of Alzheimer's Disease With Neurofeedback

Primary Purpose

Alzheimer Dementia (AD), Elderly

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rtfMRI neurofeedback training
3T MRI
Sponsored by
University Hospital, Aachen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Dementia (AD) focused on measuring neurofeedback, real-time functional MRI, parahippocampus

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Healthy elderly experimental group

    Patient group

    Healthy elderly sham-feedback group

    Arm Description

    Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI).

    Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI).

    Feedback of the postcentral gyrus using rtfMRI neurofeedback training (using 3T MRI).

    Outcomes

    Primary Outcome Measures

    Visual and Verbal Memory Test (VVM)
    Neuropsychological assessment including visuo-spatial memory

    Secondary Outcome Measures

    Montreal Cognitive Assessment (MoCA)
    Neuropsychological instrument for a general cognitive screening
    Wechsler Memory Scale Revised (WMS-R)
    Subtests from the WMS-R were used to assess several domains of memory
    Trail Making Test (TMT)
    TMT-A and -B were used to assess cognitive processing speed and task switching capabilities.
    Visual Patterns Test (VPT)
    The VPT was used to assess visual working memory capabilities.
    Parahippocampal activation
    Activation of the parahippocampal gyrus during neurofeedback training as measured with fMRI
    Memory-related functional connectivity using Granger Causality Analysis (GCA)
    Change of functional connectivity mainly between memory-associated brain regions over the course of neurofeedback training characterised by GCA
    Change of brain structure
    Assessment of grey matter volume in the entire brain
    Change of brain function
    Assessment of activation in the entire brain

    Full Information

    First Posted
    February 23, 2017
    Last Updated
    February 28, 2017
    Sponsor
    University Hospital, Aachen
    Collaborators
    Alzheimer Forschung Initiative e.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03070821
    Brief Title
    Therapy of Alzheimer's Disease With Neurofeedback
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 30, 2013 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Aachen
    Collaborators
    Alzheimer Forschung Initiative e.V.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Dementia (AD), Elderly
    Keywords
    neurofeedback, real-time functional MRI, parahippocampus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    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.
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy elderly experimental group
    Arm Type
    Experimental
    Arm Description
    Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI).
    Arm Title
    Patient group
    Arm Type
    Experimental
    Arm Description
    Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI).
    Arm Title
    Healthy elderly sham-feedback group
    Arm Type
    Sham Comparator
    Arm Description
    Feedback of the postcentral gyrus using rtfMRI neurofeedback training (using 3T MRI).
    Intervention Type
    Other
    Intervention Name(s)
    rtfMRI neurofeedback training
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    3T MRI
    Intervention Description
    A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.
    Primary Outcome Measure Information:
    Title
    Visual and Verbal Memory Test (VVM)
    Description
    Neuropsychological assessment including visuo-spatial memory
    Time Frame
    2.5 weeks
    Secondary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    Neuropsychological instrument for a general cognitive screening
    Time Frame
    2.5 weeks
    Title
    Wechsler Memory Scale Revised (WMS-R)
    Description
    Subtests from the WMS-R were used to assess several domains of memory
    Time Frame
    2.5 weeks
    Title
    Trail Making Test (TMT)
    Description
    TMT-A and -B were used to assess cognitive processing speed and task switching capabilities.
    Time Frame
    2.5 weeks
    Title
    Visual Patterns Test (VPT)
    Description
    The VPT was used to assess visual working memory capabilities.
    Time Frame
    2.5 weeks
    Title
    Parahippocampal activation
    Description
    Activation of the parahippocampal gyrus during neurofeedback training as measured with fMRI
    Time Frame
    2.5 weeks
    Title
    Memory-related functional connectivity using Granger Causality Analysis (GCA)
    Description
    Change of functional connectivity mainly between memory-associated brain regions over the course of neurofeedback training characterised by GCA
    Time Frame
    2.5 weeks
    Title
    Change of brain structure
    Description
    Assessment of grey matter volume in the entire brain
    Time Frame
    2.5 weeks
    Title
    Change of brain function
    Description
    Assessment of activation in the entire brain
    Time Frame
    2.5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathrin Reetz, Prof. Dr.
    Organizational Affiliation
    University Hospital, Aachen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Therapy of Alzheimer's Disease With Neurofeedback

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