Therapy of Alzheimer's Disease With Neurofeedback

Elderly Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070821
• Other study ID #: AFI 13812
• Status: Completed
• Phase: N/A
• First received: February 23, 2017
• Last updated: February 28, 2017
• Start date: January 30, 2013
• Est. completion date: June 30, 2016

Study information

• Verified date: February 2017
• Source: University Hospital, Aachen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Dementia (AD)
• Alzheimer Disease
• Dementia
• Elderly

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Aachen	Alzheimer Forschung Initiative e.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual and Verbal Memory Test (VVM)	Neuropsychological assessment including visuo-spatial memory	2.5 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	Neuropsychological instrument for a general cognitive screening	2.5 weeks
Secondary	Wechsler Memory Scale Revised (WMS-R)	Subtests from the WMS-R were used to assess several domains of memory	2.5 weeks
Secondary	Trail Making Test (TMT)	TMT-A and -B were used to assess cognitive processing speed and task switching capabilities.	2.5 weeks
Secondary	Visual Patterns Test (VPT)	The VPT was used to assess visual working memory capabilities.	2.5 weeks
Secondary	Parahippocampal activation	Activation of the parahippocampal gyrus during neurofeedback training as measured with fMRI	2.5 weeks
Secondary	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	2.5 weeks
Secondary	Change of brain structure	Assessment of grey matter volume in the entire brain	2.5 weeks
Secondary	Change of brain function	Assessment of activation in the entire brain	2.5 weeks