Real-time fMRI Neurofeedback in Patients With MCI

University of Bern

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Other: real-time fMRI based neurofeedback from the hippocampus; Other: real-time fMRI based neurofeedback from another brain area

Study type: Interventional

Funder types: Other

Identifiers

NCT04020744

1163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 4 patient groups

healthy elderly participants receiving feedback from the hippocampus

Active Comparator group

Description:

This group will consist of healthy elderly volunteers, who will receive feedback from their hippocampal activity.

Treatment:

Other: real-time fMRI based neurofeedback from the hippocampus

healthy elderly participants receiving feedback from another area

Sham Comparator group

Description:

This group will consist of healthy elderly volunteers, who will receive feedback from another brain area.

Treatment:

Other: real-time fMRI based neurofeedback from another brain area

patients with MCI receiving feedback from the hippocampus

Experimental group

Description:

This group will consist of patients with mild cognitive impairment, who will receive feedback from their hippocampal activity.

Treatment:

Other: real-time fMRI based neurofeedback from the hippocampus

patients with MCI receiving feedback from another brain area

Sham Comparator group

Description:

This group will consist of patients with mild cognitive impairment, who will receive feedback from another brain area.

Treatment:

Other: real-time fMRI based neurofeedback from another brain area