Clinical trial NCT03070821: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Dementia (AD)
Elderly
Keywords: neurofeedback
real-time functional MRI
parahippocampus
Lead sponsor: University Hospital, Aachen
Sponsor class: OTHER
Collaborators: name: Alzheimer Forschung Initiative e.V.
First posted: 2017-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual and Verbal Memory Test (VVM)
timeFrame: 2.5 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 2.5 weeks
measure: Wechsler Memory Scale Revised (WMS-R)
timeFrame: 2.5 weeks
measure: Trail Making Test (TMT)
timeFrame: 2.5 weeks
measure: Visual Patterns Test (VPT)
timeFrame: 2.5 weeks
measure: Parahippocampal activation
timeFrame: 2.5 weeks
measure: Memory-related functional connectivity using Granger Causality Analysis (GCA)
timeFrame: 2.5 weeks
measure: Change of brain structure
timeFrame: 2.5 weeks
measure: Change of brain function
timeFrame: 2.5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Aachen
name: Kathrin Reetz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: