Real-time fMRI Neurofeedback in Patients With MCI

NCT04020744 | Completed DMC

• 1 other identifier: 1163
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of change in memory performance

  Directly after the intervention

• Rate of change from in memory performance (behavioural)

  Directly after the intervention

Other Outcomes (2)

• Strategies for Regulation of hippocampal activity

  Intervention

• Predictors of neurofeedback success

  Post-Intervention

Study Arms (4)

healthy elderly participants receiving feedback from the hippocampus

ACTIVE COMPARATOR

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

Other: real-time fMRI based neurofeedback from the hippocampus

healthy elderly participants receiving feedback from another area

SHAM COMPARATOR

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

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

patients with MCI receiving feedback from the hippocampus

EXPERIMENTAL

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

Other: real-time fMRI based neurofeedback from the hippocampus

patients with MCI receiving feedback from another brain area

SHAM COMPARATOR

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

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

Interventions

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.

healthy elderly participants receiving feedback from the hippocampus; patients with MCI receiving feedback from the hippocampus

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.

healthy elderly participants receiving feedback from another area; patients with MCI receiving feedback from another brain area

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intact activities of daily living
• Fluent in German
• Normal/corrected-to-normal vision
• Written informed consent

You may not qualify if:

• Dementia
• Current/lifetime severe psychiatric or neurological disorder
• History of seizures
• Psychotropic medication
• Currently/lifetime drug or alcohol abuse
• Brain damage
• Magnetisable implants

Sponsors & Collaborators

• University of Bern: lead
• University of Zurich: collaborator

Study Sites (2)

SITEM (Swiss Institute for Translational and Entrepreneurial Medicine)

Bern, 3010, Switzerland

Location

University of Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33563242 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jessica Peter, PD Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

• Stefan Klöppel, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

• Frank Scharnowski, Prof. Dr.

  University of Vienna

  STUDY CHAIR

• Roland Wiest, Prof. Dr.

  University of Bern

  STUDY CHAIR

• Katharina Klink

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: For blinding of the participants, they will be told that they will be asked to regulate one of two brain regions, without mentioning the specific area.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 16, 2019
• Study Start: July 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)