Mild Cognitive ImpairmentNCT04020744
Real-time fMRI Neurofeedback in Patients With MCI
A study testing real-time fMRI based neurofeedback from the hippocampus and real-time fMRI based neurofeedback from another brain area in people with Mild Cognitive Impairment, run by University of Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- real-time fMRI based neurofeedback from the hippocampus and real-time fMRI based neurofeedback from another brain area
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jul 2020to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intact activities of daily living
- Fluent in German
- Normal/corrected-to-normal vision
- Written informed consent
Who cannot join
- Dementia
- Current/lifetime severe psychiatric or neurological disorder
- History of seizures
- Psychotropic medication
- Currently/lifetime drug or alcohol abuse
- Brain damage
- Magnetisable implants
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
SITEM (Swiss Institute for Translational and Entrepreneurial Medicine)
Bern, 3010
University of Zurich
Zurich, 8092
About this study
Official title: Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems
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.
Read the 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
- Being tested
- real-time fMRI based neurofeedback from the hippocampus, real-time fMRI based neurofeedback from another brain area
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRI based neurofeedback from the hippocampusOther
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 areaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: real-time fMRI based neurofeedback from another brain area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in hippocampal activity during a memory task
Measured by fMRI (rate of change in activity from baseline to after the intervention)
Measured: Directly after the intervention
Secondary outcomes (2)
Rate of change in memory performance
Measured by fMRI (memory performance change from baseline to after the intervention)
Measured: Directly after the intervention
Rate of change from in memory performance (behavioural)
Measured behaviourally (memory performance change from baseline to after the intervention)
Measured: Directly after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Jul 2020
- Primary completion31 Oct 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Jessica Peter, PD Dr., Principal investigator, University of BernStefan Klöppel, Prof. Dr., Principal investigator, University of BernFrank Scharnowski, Prof. Dr., Study chair, University of ViennaRoland Wiest, Prof. Dr., Study chair, University of BernKatharina Klink, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020744
- Sponsor's protocol ID
- 1163
- Status last verified
- May 2024
- First submitted
- 4 Jul 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33563242
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems
- ClinicalTrials.gov ID
- NCT04020744
- Acronym / sponsor ID
- 1163
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy elderly participants receiving feedback from the hippocampus | Active comparator | Other: real-time fMRI based neurofeedback from the hippocampusThis group will consist of healthy elderly volunteers, who will receive feedback from their hippocampal activity. |
| healthy elderly participants receiving feedback from another area | Sham comparator | Other: real-time fMRI based neurofeedback from another brain areaThis group will consist of healthy elderly volunteers, who will receive feedback from another brain area. |
| patients with MCI receiving feedback from the hippocampus | Experimental | Other: real-time fMRI based neurofeedback from the hippocampusThis group will consist of patients with mild cognitive impairment, who will receive feedback from their hippocampal activity. |
| patients with MCI receiving feedback from another brain area | Sham comparator | Other: real-time fMRI based neurofeedback from another brain areaThis group will consist of patients with mild cognitive impairment, who will receive feedback from another brain area. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intact activities of daily living
- Fluent in German
- Normal/corrected-to-normal vision
- Written informed consent
Key exclusion criteria (7 listed)
- Dementia
- Current/lifetime severe psychiatric or neurological disorder
- History of seizures
- Psychotropic medication
- Currently/lifetime drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time fMRI based neurofeedback from the hippocampusDuring 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. | Other | healthy elderly participants receiving feedback from the hippocampus, patients with MCI receiving feedback from the hippocampus |
| real-time fMRI based neurofeedback from another brain areaDuring 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. | Other | healthy elderly participants receiving feedback from another area, patients with MCI receiving feedback from another brain area |
Primary outcome
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)
2 secondary outcomes
Rate of change in memory performance
Time frame: Directly after the intervention
Rate of change from in memory performance (behavioural)
Time frame: Directly after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 33563242Klink 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Peter, PD Dr. principal investigator
University of Bern
Stefan Klöppel, Prof. Dr. principal investigator
University of Bern
Frank Scharnowski, Prof. Dr. study chair
University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time fMRI based neurofeedback from the hippocampus and real-time fMRI based neurofeedback from another brain area in people with Mild Cognitive Impairment, run by University of Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in hippocampal activity during a memory task (time frame: Directly after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.