Real-time fMRI Neurofeedback in Patients With MCI

NCT ID: NCT04020744

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-01-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

healthy elderly participants receiving feedback from the hippocampus

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

Group Type: ACTIVE_COMPARATOR

real-time fMRI based neurofeedback from the hippocampus

Intervention Type: 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.

healthy elderly participants receiving feedback from another area

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

Group Type: SHAM_COMPARATOR

real-time fMRI based neurofeedback from another brain area

Intervention Type: 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.

patients with MCI receiving feedback from the hippocampus

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

Group Type: EXPERIMENTAL

real-time fMRI based neurofeedback from the hippocampus

Intervention Type: 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.

patients with MCI receiving feedback from another brain area

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

Group Type: SHAM_COMPARATOR

real-time fMRI based neurofeedback from another brain area

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Peter, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Stefan Klöppel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Frank Scharnowski, Prof. Dr.

Role: STUDY_CHAIR

University of Vienna

Roland Wiest, Prof. Dr.

Role: STUDY_CHAIR

University of Bern

Katharina Klink

Role: STUDY_CHAIR

University of Bern

Locations

SITEM (Swiss Institute for Translational and Entrepreneurial Medicine)

Bern, , Switzerland

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 33563242 (View on PubMed)

Other Identifiers

1163

Identifier Type: -

Identifier Source: org_study_id