Clinical trial NCT04020744: Real-time fMRI Neurofeedback in Patients With MCI
Official title: Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2019-07-16
Enrollment: 84
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of change in hippocampal activity during a memory task
timeFrame: Directly after the intervention
Secondary outcomes:
measure: Rate of change in memory performance
timeFrame: Directly after the intervention
measure: Rate of change from in memory performance (behavioural)
timeFrame: Directly after the intervention
Other outcomes:
measure: Strategies for Regulation of hippocampal activity
timeFrame: Intervention
measure: Predictors of neurofeedback success
timeFrame: Post-Intervention
Locations:
city: Bern
country: Switzerland
facility: SITEM (Swiss Institute for Translational and Entrepreneurial Medicine)
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Bern
name: Jessica Peter, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Stefan Klöppel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vienna
name: Frank Scharnowski, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Bern
name: Roland Wiest, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Bern
name: Katharina Klink
role: STUDY_CHAIR
References:
citation: Klink K, Jaun U, Federspiel A, Wunderlin M, Teunissen CE, Kiefer C, Wiest R, Scharnowski F, Sladky R, Haugg A, Hellrung L, Peter J. Targeting hippocampal hyperactivity with real-time fMRI neurofeedback: protocol of a single-blind randomized controlled trial in mild cognitive impairment. BMC Psychiatry. 2021 Feb 9;21(1):87. doi: 10.1186/s12888-021-03091-8.