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Therapy of Alzheimer's Disease With Neurofeedback

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03070821
Enrollment
30
Registered
2017-03-06
Start date
2013-01-30
Completion date
2016-06-30
Last updated
2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Dementia (AD), Elderly

Keywords

neurofeedback, real-time functional MRI, parahippocampus

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.

Interventions

OTHERrtfMRI 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.

DEVICE3T MRI

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

Sponsors

Alzheimer Forschung Initiative e.V.
CollaboratorUNKNOWN
University Hospital, Aachen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual and Verbal Memory Test (VVM)2.5 weeksNeuropsychological assessment including visuo-spatial memory

Secondary

MeasureTime frameDescription
Wechsler Memory Scale Revised (WMS-R)2.5 weeksSubtests from the WMS-R were used to assess several domains of memory
Trail Making Test (TMT)2.5 weeksTMT-A and -B were used to assess cognitive processing speed and task switching capabilities.
Visual Patterns Test (VPT)2.5 weeksThe VPT was used to assess visual working memory capabilities.
Montreal Cognitive Assessment (MoCA)2.5 weeksNeuropsychological instrument for a general cognitive screening
Memory-related functional connectivity using Granger Causality Analysis (GCA)2.5 weeksChange of functional connectivity mainly between memory-associated brain regions over the course of neurofeedback training characterised by GCA
Change of brain structure2.5 weeksAssessment of grey matter volume in the entire brain
Change of brain function2.5 weeksAssessment of activation in the entire brain
Parahippocampal activation2.5 weeksActivation of the parahippocampal gyrus during neurofeedback training as measured with fMRI

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026