Real-time fMRI Neurofeedback in Patients With MCI

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Other: real-time fMRI based neurofeedback from the hippocampus; Other: real-time fMRI based neurofeedback from another brain area

• Registration Number: NCT04020744
• Lead Sponsor: University of Bern

Brief Summary

Increased activity in the hippocampus (i.e., hyperactivity) during a fMRI memory task was found in patients with Mild Cognitive Impairment due to Alzheimer's disease (MCI). Those with increased hippocampal activity exhibited elevated clinical progression. Reducing hippocampal hyperactivity with pharmacological treatment reduced hyperactivity and improved memory performance. The investigators of this study will test whether real-time fMRI neurofeedback will also downregulate hippocampal activity and thereby improve memory performance.

Detailed Description

Alzheimer's disease (AD) is an insidious and progressive neurodegenerative disorder accompanied by extracellular deposits of beta-amyloid ( aβ) and the increase of cognitive dysfunctions. Several functional magnet resonance imaging (fMRI) studies in the prodromal stage of AD (i.e., in MCI) have found increased hippocampal activity during a memory task to be predictive of memory worsening and disease progression. In this study the investigators are aiming to reduce hippocampal hyperactivity with real-time fMRI neurofeedback and test whether this will improve memory performance.

This study will use a randomized, single-blind, parallel group design. Patients with MCI and healthy participants will be assigned to receive feedback from either the hippocampus (experimental group, N=42) or from another brain area (alternate ROI feedback group, N=42). All participants will be instructed to downregulate activity.

Study Timeline

• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Study Start: 2020-07-01
• Primary Completion: 2023-10-31
• Study Completion: 2024-01-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Intact activities of daily living
• Fluent in German
• Normal/corrected-to-normal vision
• Written informed consent

Exclusion Criteria

• Dementia
• Current/lifetime severe psychiatric or neurological disorder
• History of seizures
• Psychotropic medication
• Currently/lifetime drug or alcohol abuse
• Brain damage
• Magnetisable implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy elderly participants receiving feedback from the hippocampus	real-time fMRI based neurofeedback from the hippocampus	This group will consist of healthy elderly volunteers, who will receive feedback from their hippocampal activity.
healthy elderly participants receiving feedback from another area	real-time fMRI based neurofeedback from another brain area	This group will consist of healthy elderly volunteers, who will receive feedback from another brain area.
patients with MCI receiving feedback from the hippocampus	real-time fMRI based neurofeedback from the hippocampus	This group will consist of patients with mild cognitive impairment, who will receive feedback from their hippocampal activity.
patients with MCI receiving feedback from another brain area	real-time fMRI based neurofeedback from another brain area	This group will consist of patients with mild cognitive impairment, who will receive feedback from another brain area.

Primary Outcome Measures

Name	Time	Method
Rate of change in hippocampal activity during a memory task	Directly after the intervention	Measured by fMRI (rate of change in activity from baseline to after the intervention)

Secondary Outcome Measures

Name	Time	Method
Rate of change in memory performance	Directly after the intervention	Measured by fMRI (memory performance change from baseline to after the intervention)
Rate of change from in memory performance (behavioural)	Directly after the intervention	Measured behaviourally (memory performance change from baseline to after the intervention)

Trial Locations

Locations (2)

University of Zurich; 🇨🇭 Zurich, Switzerland

SITEM (Swiss Institute for Translational and Entrepreneurial Medicine); 🇨🇭 Bern, Switzerland