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Completed

NCT Number: NCT04020744

Real-time fMRI Neurofeedback in Patients With MCI

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

real-time fMRI based neurofeedback from the hippocampus

Other

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

Other

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.

Primary outcomes

  1. Rate of change in hippocampal activity during a memory task

    Time frame: Directly after the intervention

    Measured by fMRI (rate of change in activity from baseline to after the intervention)

Secondary outcomes

  1. Rate of change in memory performance

    Time frame: Directly after the intervention

    Measured by fMRI (memory performance change from baseline to after the intervention)

  2. Rate of change from in memory performance (behavioural)

    Time frame: Directly after the intervention

    Measured behaviourally (memory performance change from baseline to after the intervention)

Other outcomes

  1. Strategies for Regulation of hippocampal activity

    Time frame: Intervention

    Which strategies were particularly helpful in downregulation of hippocampal activity (number of times the strategies were mentioned)

  2. Predictors of neurofeedback success

    Time frame: Post-Intervention

    Variables extracted from questionnaires that may predict who will respond to neurofeedback

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 16, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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