Mild Cognitive Impairment Clinical Trial
Official title:
Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems
NCT number | NCT04020744 |
Other study ID # | 1163 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | January 31, 2024 |
Verified date | May 2024 |
Source | University of Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | January 31, 2024 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | SITEM (Swiss Institute for Translational and Entrepreneurial Medicine) | Bern | |
Switzerland | University of Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Bern | University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Strategies for Regulation of hippocampal activity | Which strategies were particularly helpful in downregulation of hippocampal activity (number of times the strategies were mentioned) | Intervention | |
Other | Predictors of neurofeedback success | Variables extracted from questionnaires that may predict who will respond to neurofeedback | Post-Intervention | |
Primary | 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 | Rate of change in memory performance | Measured by fMRI (memory performance change from baseline to after the intervention) | Directly after the intervention | |
Secondary | Rate of change from in memory performance (behavioural) | Measured behaviourally (memory performance change from baseline to after the intervention) | Directly after the intervention |
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