Alzheimer Dementia (AD)NCT03070821
Therapy of Alzheimer's Disease With Neurofeedback
A study testing rtfMRI neurofeedback training and 3T MRI in people with Alzheimer Dementia (AD) and Elderly, run by University Hospital, Aachen.
Trial summary
The project aims to investigate in patients of Alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional MRI (fMRI) can improve cognitive ability. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia (AD), Elderly
- What is being tested?
- rtfMRI neurofeedback training and 3T MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2013to 30 Jun 2016
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Native speakers of German
- Naive to neurofeedback experiments
- Ability to provide written informed consent
Who cannot join
- Metallic implants (MR-safety)
- Neurological/psychiatric disease (except Alzheimer's disease in the patient group)
- Use of psychoactive medication (expect medication for Alzheimer's disease)
- Familiarity with the study site
About this study
Official title: Neurofeedback and Follow-up With Real-time fMRI to Investigate Cognitive Function in Patients of Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD)
The project aims to investigate in patients of Alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive ability, as well as functional and structural measures of the brain.
Over the course of the study subjects will learn a real-world footpath. During neurofeedback training subjects are then asked to recall this footpath while simultaneously trying to modulate their own brain activation based on feedback. Feedback is given about the parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial memory, which is known to be affected early by Alzheimer's disease pathology.
Read more
Before and after the training cognitive ability is assessed using neuropsychological tests mainly measuring numerous domains of memory.
The investigators hypothesise that the training leads to an improvement of the trained cognitive domain, but also induces changes in brain structure and function.
- Conditions
- Alzheimer Dementia (AD), Elderly
- Being tested
- rtfMRI neurofeedback training, 3T MRI
- Keywords
- neurofeedback, real-time functional MRI, parahippocampus
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rtfMRI neurofeedback trainingOther
Information about the state of brain activation was given to subjects. That information was visualised as a thermometer bar. Subjects tried to modulate that activation while performing a mental imagery task.
3T MRIDevice
A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.
| Study group | Role | What they receive |
|---|---|---|
| Healthy elderly experimental group | Experimental | Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI). Receives: Other: rtfMRI neurofeedback training; Device: 3T MRI |
| Patient group | Experimental | Feedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI). Receives: Other: rtfMRI neurofeedback training; Device: 3T MRI |
| Healthy elderly sham-feedback group | Sham comparator | Feedback of the postcentral gyrus using rtfMRI neurofeedback training (using 3T MRI). Receives: Other: rtfMRI neurofeedback training; Device: 3T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual and Verbal Memory Test (VVM)
Neuropsychological assessment including visuo-spatial memory
Measured: 2.5 weeks
Secondary outcomes (8)
Montreal Cognitive Assessment (MoCA)
Neuropsychological instrument for a general cognitive screening
Measured: 2.5 weeks
Wechsler Memory Scale Revised (WMS-R)
Subtests from the WMS-R were used to assess several domains of memory
Measured: 2.5 weeks
Trail Making Test (TMT)
TMT-A and -B were used to assess cognitive processing speed and task switching capabilities.
Measured: 2.5 weeks
Visual Patterns Test (VPT)
The VPT was used to assess visual working memory capabilities.
Measured: 2.5 weeks
Parahippocampal activation
Activation of the parahippocampal gyrus during neurofeedback training as measured with fMRI
Measured: 2.5 weeks
Memory-related functional connectivity using Granger Causality Analysis (GCA)
Change of functional connectivity mainly between memory-associated brain regions over the course of neurofeedback training characterised by GCA
Measured: 2.5 weeks
Change of brain structure
Assessment of grey matter volume in the entire brain
Measured: 2.5 weeks
Change of brain function
Assessment of activation in the entire brain
Measured: 2.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start30 Jan 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The design is a pre-test/post-test study with an intervention of three parallel groups. The groups are a healthy elderly experimental group, a patient group and a healthy elderly sham-feedback group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aachen
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Forschung Initiative e.V.
- Responsible party
- Principal investigator, Kathrin Reetz, University Hospital, Aachen
- Investigators
- Kathrin Reetz, Prof. Dr., Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070821
- Sponsor's protocol ID
- AFI 13812
- Status last verified
- Feb 2017
- First submitted
- 23 Feb 2017
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback and Follow-up With Real-time fMRI to Investigate Cognitive Function in Patients of Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT03070821
- Acronym / sponsor ID
- AFI 13812
- Conditions
- Alzheimer Dementia (AD), Elderly
- Keywords
- neurofeedback, real-time functional MRI, parahippocampus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, AachenUniversity, hospital or other
- Collaborators
- Alzheimer Forschung Initiative e.V.
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 6 Mar 2017 (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.
The project aims to investigate in patients of Alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive ability, as well as functional and structural measures of the brain.
Over the course of the study subjects will learn a real-world footpath. During neurofeedback training subjects are then asked to recall this footpath while simultaneously trying to modulate their own brain activation based on feedback. Feedback is given about the parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial memory, which is known to be affected early by Alzheimer's disease pathology.
Before and after the training cognitive ability is assessed using neuropsychological tests mainly measuring numerous domains of memory.
The investigators hypothesise that the training leads to an improvement of the trained cognitive domain, but also induces changes in brain structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The design is a pre-test/post-test study with an intervention of three parallel groups. The groups are a healthy elderly experimental group, a patient group and a healthy elderly sham-feedback group.
| Arm | Type | Receives |
|---|---|---|
| Healthy elderly experimental group | Experimental | Other: rtfMRI neurofeedback training, Device: 3T MRIFeedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI). |
| Patient group | Experimental | Other: rtfMRI neurofeedback training, Device: 3T MRIFeedback of the parahippocampal gyrus using rtfMRI neurofeedback training (using 3T MRI). |
| Healthy elderly sham-feedback group | Sham comparator | Other: rtfMRI neurofeedback training, Device: 3T MRIFeedback of the postcentral gyrus using rtfMRI neurofeedback training (using 3T MRI). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Native speakers of German
- Naive to neurofeedback experiments
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Metallic implants (MR-safety)
- Neurological/psychiatric disease (except Alzheimer's disease in the patient group)
- Use of psychoactive medication (expect medication for Alzheimer's disease)
- Familiarity with the study site
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 |
|---|---|---|
| rtfMRI neurofeedback trainingInformation about the state of brain activation was given to subjects. That information was visualised as a thermometer bar. Subjects tried to modulate that activation while performing a mental imagery task. | Other | Healthy elderly experimental group, Healthy elderly sham-feedback group, Patient group |
| 3T MRIA 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training. | Device | Healthy elderly experimental group, Healthy elderly sham-feedback group, Patient group |
Primary outcome
Visual and Verbal Memory Test (VVM)
Time frame: 2.5 weeks
Neuropsychological assessment including visuo-spatial memory
8 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 2.5 weeks
Wechsler Memory Scale Revised (WMS-R)
Time frame: 2.5 weeks
Trail Making Test (TMT)
Time frame: 2.5 weeks
Visual Patterns Test (VPT)
Time frame: 2.5 weeks
Parahippocampal activation
Time frame: 2.5 weeks
Memory-related functional connectivity using Granger Causality Analysis (GCA)
Time frame: 2.5 weeks
Change of brain structure
Time frame: 2.5 weeks
Change of brain function
Time frame: 2.5 weeks
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 6 Mar 2017.
- 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.
Kathrin Reetz, Prof. Dr. principal investigator
University Hospital, Aachen
Questions about this trial
What is this clinical trial studying?
A study testing rtfMRI neurofeedback training and 3T MRI in people with Alzheimer Dementia (AD) and Elderly, run by University Hospital, Aachen.
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 3 inclusion and 4 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual and Verbal Memory Test (VVM) (time frame: 2.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2017.