Therapy of Alzheimer's Disease With Neurofeedback

NCT03070821 | Completed

• 1 other identifier: AFI 13812
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Dementia (AD); Elderly

Keywords

neurofeedback; real-time functional MRI; parahippocampus

Outcome Measures

Primary Outcomes (1)

• Visual and Verbal Memory Test (VVM)

  Neuropsychological assessment including visuo-spatial memory

  2.5 weeks

Secondary Outcomes (8)

• Montreal Cognitive Assessment (MoCA)

  2.5 weeks

• Wechsler Memory Scale Revised (WMS-R)

  2.5 weeks

• Trail Making Test (TMT)

  2.5 weeks

• Visual Patterns Test (VPT)

  2.5 weeks

• Parahippocampal activation

  2.5 weeks

Study Arms (3)

Healthy elderly experimental group

EXPERIMENTAL

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

Other: rtfMRI neurofeedback training; Device: 3T MRI

Patient group

EXPERIMENTAL

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

Other: rtfMRI neurofeedback training; Device: 3T MRI

Healthy elderly sham-feedback group

SHAM COMPARATOR

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

Other: rtfMRI neurofeedback training; Device: 3T MRI

Interventions

rtfMRI neurofeedback training OTHER

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.

Healthy elderly experimental group; Healthy elderly sham-feedback group; Patient group

3T MRI DEVICE

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

Healthy elderly experimental group; Healthy elderly sham-feedback group; Patient group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Native speakers of German
• Naive to neurofeedback experiments
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Aachen: lead
• Alzheimer Forschung Initiative e.V.: collaborator

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kathrin Reetz, Prof. Dr.

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Healthy subjects in the sham feedback condition were not aware of their group membership, but were debriefed at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Memory Clinic and/or Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 6, 2017
• Study Start: January 30, 2013
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: March 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share