Real-time fMRI Neurofeedback in Patients With MCI

Mild Cognitive Impairment Clinical Trial

Official title:

Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020744
• Other study ID #: 1163
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2024
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• real-time fMRI based neurofeedback from the hippocampus
During real-time fMRI neurofeedback, participants are trained to 'control' hippocampal activity. The training is accomplished by continuously measuring brain activity, analysing it in real-time, and then providing feedback about the current (and the targeted) brain activity to the participant.
• real-time fMRI based neurofeedback from another brain area
During real-time fMRI neurofeedback, participants are trained to 'control' hippocampal activity. The training is accomplished by continuously measuring brain activity, analysing it in real-time, and then providing feedback about the current (and the targeted) brain activity to the participant.

Locations

Country	Name	City	State
Switzerland	SITEM (Swiss Institute for Translational and Entrepreneurial Medicine)	Bern
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Strategies for Regulation of hippocampal activity	Which strategies were particularly helpful in downregulation of hippocampal activity (number of times the strategies were mentioned)	Intervention
Other	Predictors of neurofeedback success	Variables extracted from questionnaires that may predict who will respond to neurofeedback	Post-Intervention
Primary	Rate of change in hippocampal activity during a memory task	Measured by fMRI (rate of change in activity from baseline to after the intervention)	Directly after the intervention
Secondary	Rate of change in memory performance	Measured by fMRI (memory performance change from baseline to after the intervention)	Directly after the intervention
Secondary	Rate of change from in memory performance (behavioural)	Measured behaviourally (memory performance change from baseline to after the intervention)	Directly after the intervention