Mild Cognitive ImpairmentNCT02987842
Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's Disease
A study testing TruScan Neurofeedback in people with Mild Cognitive Impairment and Alzheimer Disease, run by Beersheva Mental Health Center at 1 site in Israel.
Trial summary
This study protocol proposes an EEG based neurofeedback (EEG-NFB) technique to upregulate the posterior cingulate cortex (PCC) in patients suffering from mild cognitive impairment (MCI) and early Alzheimer's disease (AD). EEG-NFB has been successfully used as a clinical tool for over 40 years. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- TruScan Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2016to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of either mild cognitive impairment or mild Alzheimer's disease
- Age > 50
Who cannot join
- Active neurological disorder
- Any axis 1 type disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's
This study protocol proposes an EEG based neurofeedback (EEG-NFB) technique to upregulate the posterior cingulate cortex (PCC) in patients suffering from mild cognitive impairment (MCI) and early Alzheimer's disease (AD).
EEG-NFB has been successfully used as a clinical tool for over 40 years. It is based on electrical activity measured near the surface of the brain using EEG and fed back to the patient within half a second.
Read more
MCI is a clinical condition considered as a precursor of AD. NFB appears to be a promising approach to treat MCI, since it has been shown to be able to induce changes in brain plasticity. This research focuses on the PCC, which has been reported to be implicated in MCI, and due to its location (proximity to the surface) accessible by means of EEG- NFB.
A preliminary research in MCI patients, conducted at our lab showed the lower the memory score was at the beginning of the training, the better a subject managed to improve later on. The investigators therefore presume that patients with early Alzheimer's disease, whose cognitive ability is more affected compared to MCI, may benefit from EEG-NFB as well, and maybe to a larger extent compared to MCI.
Read the detailed description
Cognitive impairment preceding dementia is called mild cognitive impairment (MCI) . Patients with MCI are at high risk for progression to Alzheimer's disease (AD), at a rate of about 12% per year. The amnestic form of MCI is the most common form, and most of the literature on the topic refers to this form of the disorder. Clinical criteria for MCI include:
- Memory complaint, preferably corroborated by an informant.
- Objective memory impairment for age and education.
- Largely intact general cognitive function.
- Essentially preserved activities of daily living.
- Not demented
Currently, there is no known cure for MCI or means of stopping or reversing its progression. Patients with Alzheimer's disease were also included in this study , as they are considered by many researchers to be on the same continuum of cognitive decline as patients with MCI which indeed, carry an increased risk for developing Alzheimer's disease.
This study relies the data from a preliminary study conducted in the investigators' lab on patients with MCI, and is meant to further validate our results. In the aforementioned study, participants managed to improve their memory score after 10 training sessions. In addition, a negative correlation between initial memory score and ability to improve was found. It is therefore hypothesized that subjects with AD may benefit as much as subjects with MCI and perhaps even to a larger extent.
Neurofeedback (NFB) is a treatment method based on learning with operant conditioning, in which a feedback (or a reward) is given in proportion with the desired physiological activity in order to improve cognition and/or behavior. This research will focus on using electrical activity measured with EEG as physiological activity to be influenced.
EEG-NFB has been successfully used as a clinical tool for over 40 years treating various disorders from epilepsy, attention deficit hyperactivity disorder (ADHD), stroke to PTSD
Electroencephalography (EEG) equipment is used to measure the electrical activity representing the neuronal activity of different parts of the brain. During the treatment, electrode(s) are placed in predetermined location. Audio and visual rewards are given when the activity is measured to be within the desired frequency range.
Since NFB has been shown to be able to induce changes in the brain plasticity, it appears to be a promising approach to treat MCI. Few studies have shown improvement in cognition of normal elderly with subjective complains of memory decline. To the best of our knowledge, this study is the first to address memory decline in MCI using EEG-based neurofeedback protocol, enhancing the individual upper alpha and peak alpha frequency.
This study will include 30 participants which will be randomly assigned into experimental or sham groups. The former will include training the individual upper alpha, while the latter will include feedback over static electrical activity of a disconnected electrode.
each participant will be trained for a total of 10 sessions over a period of 5 weeks (2 training sessions per week), lasting approx. 1 hour. Cognitive evaluations will take place at baseline, after the training sessions have ended and at 30 days after the last session.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- TruScan Neurofeedback
- Keywords
- Mild cognitive impairment, Alzhiemer's disease, Neurofeedback, EEG
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruScan NeurofeedbackDevice
Neurofeedback and quantitative EEG system
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in the experimental group will receive feedback using the TruScan Neurofeedback system in order to increase the power of EEG in the range of their individual upper alpha (as determined by the peak alpha frequency) Receives: Device: TruScan Neurofeedback |
| Sham group | Sham comparator | Patients in the sham group will receive feedback using the TruScan Neurofeedback system for electrical static activity of a disconnected electrode. Receives: Device: TruScan Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory performance
improvement in memory performance
Measured: 6 weeks
Secondary outcomes (2)
General cognitive performance improvement
improvement in other cognitive domains
Measured: 6 weeks
qEEG
Improvement in upper alpha to lower alpha power ratio and of peak alpha frequency
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doron Todder, Beersheva Mental Health Center
- Investigators
- Doron Todder, MD/PhD, Principal investigator, Beersheva Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987842
- Sponsor's protocol ID
- BeershevaMHC
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Angelakis E, Stathopoulou S, Frymiare JL, Green DL, Lubar JF, Kounios J. EEG neurofeedback: a brief overview and an example of peak alpha frequency training for cognitive enhancement in the elderly. Clin Neuropsychol. 2007 Jan;21(1):110-29. doi: 10.1080/13854040600744839.
PubMed 17366280Becerra J, Fernandez T, Roca-Stappung M, Diaz-Comas L, Galan L, Bosch J, Espino M, Moreno AJ, Harmony T. Neurofeedback in healthy elderly human subjects with electroencephalographic risk for cognitive disorder. J Alzheimers Dis. 2012;28(2):357-67. doi: 10.3233/JAD-2011-111055.
PubMed 22002790Jin G, Li K, Hu Y, Qin Y, Wang X, Xiang J, Yang Y, Lu J, Zhong N. Amnestic mild cognitive impairment: functional MR imaging study of response in posterior cingulate cortex and adjacent precuneus during problem-solving tasks. Radiology. 2011 Nov;261(2):525-33. doi: 10.1148/radiol.11102186. Epub 2011 Jul 25.
PubMed 21788526Panza F, Frisardi V, Capurso C, D'Introno A, Colacicco AM, Chiloiro R, Dellegrazie F, Di Palo A, Capurso A, Solfrizzi V. Effect of donepezil on the continuum of depressive symptoms, mild cognitive impairment, and progression to dementia. J Am Geriatr Soc. 2010 Feb;58(2):389-90. doi: 10.1111/j.1532-5415.2009.02702.x. No abstract available.
PubMed 20370868Ros T, Munneke MA, Ruge D, Gruzelier JH, Rothwell JC. Endogenous control of waking brain rhythms induces neuroplasticity in humans. Eur J Neurosci. 2010 Feb;31(4):770-8. doi: 10.1111/j.1460-9568.2010.07100.x.
PubMed 20384819Klimesch W. EEG alpha and theta oscillations reflect cognitive and memory performance: a review and analysis. Brain Res Brain Res Rev. 1999 Apr;29(2-3):169-95. doi: 10.1016/s0165-0173(98)00056-3.
PubMed 10209231Jelic V, Johansson SE, Almkvist O, Shigeta M, Julin P, Nordberg A, Winblad B, Wahlund LO. Quantitative electroencephalography in mild cognitive impairment: longitudinal changes and possible prediction of Alzheimer's disease. Neurobiol Aging. 2000 Jul-Aug;21(4):533-40. doi: 10.1016/s0197-4580(00)00153-6.
PubMed 10924766Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
PubMed 24605806Association for Applied Psychophysiology and Biofeedback. Template for developing guidelines for the evaluation of the clinical efficacy of psychophysiological interventions. Appl Psychophysiol Biofeedback. 2002 Dec;27(4):273-81. doi: 10.1023/a:1021061318355.
PubMed 12557455Zoefel B, Huster RJ, Herrmann CS. Neurofeedback training of the upper alpha frequency band in EEG improves cognitive performance. Neuroimage. 2011 Jan 15;54(2):1427-31. doi: 10.1016/j.neuroimage.2010.08.078. Epub 2010 Sep 17.
PubMed 20850552
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's
- ClinicalTrials.gov ID
- NCT02987842
- Acronym / sponsor ID
- BeershevaMHC
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Mild cognitive impairment, Alzhiemer's disease, Neurofeedback, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- 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.
This study protocol proposes an EEG based neurofeedback (EEG-NFB) technique to upregulate the posterior cingulate cortex (PCC) in patients suffering from mild cognitive impairment (MCI) and early Alzheimer's disease (AD).
EEG-NFB has been successfully used as a clinical tool for over 40 years. It is based on electrical activity measured near the surface of the brain using EEG and fed back to the patient within half a second.
MCI is a clinical condition considered as a precursor of AD. NFB appears to be a promising approach to treat MCI, since it has been shown to be able to induce changes in brain plasticity. This research focuses on the PCC, which has been reported to be implicated in MCI, and due to its location (proximity to the surface) accessible by means of EEG- NFB.
A preliminary research in MCI patients, conducted at our lab showed the lower the memory score was at the beginning of the training, the better a subject managed to improve later on. The investigators therefore presume that patients with early Alzheimer's disease, whose cognitive ability is more affected compared to MCI, may benefit from EEG-NFB as well, and maybe to a larger extent compared to MCI.
Detailed description
Cognitive impairment preceding dementia is called mild cognitive impairment (MCI) . Patients with MCI are at high risk for progression to Alzheimer's disease (AD), at a rate of about 12% per year. The amnestic form of MCI is the most common form, and most of the literature on the topic refers to this form of the disorder. Clinical criteria for MCI include:
- Memory complaint, preferably corroborated by an informant.
- Objective memory impairment for age and education.
- Largely intact general cognitive function.
- Essentially preserved activities of daily living.
- Not demented
Currently, there is no known cure for MCI or means of stopping or reversing its progression. Patients with Alzheimer's disease were also included in this study , as they are considered by many researchers to be on the same continuum of cognitive decline as patients with MCI which indeed, carry an increased risk for developing Alzheimer's disease.
This study relies the data from a preliminary study conducted in the investigators' lab on patients with MCI, and is meant to further validate our results. In the aforementioned study, participants managed to improve their memory score after 10 training sessions. In addition, a negative correlation between initial memory score and ability to improve was found. It is therefore hypothesized that subjects with AD may benefit as much as subjects with MCI and perhaps even to a larger extent.
Neurofeedback (NFB) is a treatment method based on learning with operant conditioning, in which a feedback (or a reward) is given in proportion with the desired physiological activity in order to improve cognition and/or behavior. This research will focus on using electrical activity measured with EEG as physiological activity to be influenced.
EEG-NFB has been successfully used as a clinical tool for over 40 years treating various disorders from epilepsy, attention deficit hyperactivity disorder (ADHD), stroke to PTSD
Electroencephalography (EEG) equipment is used to measure the electrical activity representing the neuronal activity of different parts of the brain. During the treatment, electrode(s) are placed in predetermined location. Audio and visual rewards are given when the activity is measured to be within the desired frequency range.
Since NFB has been shown to be able to induce changes in the brain plasticity, it appears to be a promising approach to treat MCI. Few studies have shown improvement in cognition of normal elderly with subjective complains of memory decline. To the best of our knowledge, this study is the first to address memory decline in MCI using EEG-based neurofeedback protocol, enhancing the individual upper alpha and peak alpha frequency.
This study will include 30 participants which will be randomly assigned into experimental or sham groups. The former will include training the individual upper alpha, while the latter will include feedback over static electrical activity of a disconnected electrode.
each participant will be trained for a total of 10 sessions over a period of 5 weeks (2 training sessions per week), lasting approx. 1 hour. Cognitive evaluations will take place at baseline, after the training sessions have ended and at 30 days after the last session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: TruScan NeurofeedbackPatients in the experimental group will receive feedback using the TruScan Neurofeedback system in order to increase the power of EEG in the range of their individual upper alpha (as determined by the peak alpha frequency) |
| Sham group | Sham comparator | Device: TruScan NeurofeedbackPatients in the sham group will receive feedback using the TruScan Neurofeedback system for electrical static activity of a disconnected electrode. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of either mild cognitive impairment or mild Alzheimer's disease
- Age > 50
Key exclusion criteria (2 listed)
- Active neurological disorder
- Any axis 1 type disorder
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 |
|---|---|---|
| TruScan NeurofeedbackNeurofeedback and quantitative EEG system | Device | Experimental group, Sham group |
Primary outcome
Memory performance
Time frame: 6 weeks
improvement in memory performance
2 secondary outcomes
General cognitive performance improvement
Time frame: 6 weeks
qEEG
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Background: PubMed 17366280Angelakis E, Stathopoulou S, Frymiare JL, Green DL, Lubar JF, Kounios J. EEG neurofeedback: a brief overview and an example of peak alpha frequency training for cognitive enhancement in the elderly. Clin Neuropsychol. 2007 Jan;21(1):110-29. doi: 10.1080/13854040600744839.
- Background: PubMed 22002790Becerra J, Fernandez T, Roca-Stappung M, Diaz-Comas L, Galan L, Bosch J, Espino M, Moreno AJ, Harmony T. Neurofeedback in healthy elderly human subjects with electroencephalographic risk for cognitive disorder. J Alzheimers Dis. 2012;28(2):357-67. doi: 10.3233/JAD-2011-111055.
- Background: PubMed 21788526Jin G, Li K, Hu Y, Qin Y, Wang X, Xiang J, Yang Y, Lu J, Zhong N. Amnestic mild cognitive impairment: functional MR imaging study of response in posterior cingulate cortex and adjacent precuneus during problem-solving tasks. Radiology. 2011 Nov;261(2):525-33. doi: 10.1148/radiol.11102186. Epub 2011 Jul 25.
- Background: PubMed 20370868Panza F, Frisardi V, Capurso C, D'Introno A, Colacicco AM, Chiloiro R, Dellegrazie F, Di Palo A, Capurso A, Solfrizzi V. Effect of donepezil on the continuum of depressive symptoms, mild cognitive impairment, and progression to dementia. J Am Geriatr Soc. 2010 Feb;58(2):389-90. doi: 10.1111/j.1532-5415.2009.02702.x. No abstract available.
- Background: PubMed 20384819Ros T, Munneke MA, Ruge D, Gruzelier JH, Rothwell JC. Endogenous control of waking brain rhythms induces neuroplasticity in humans. Eur J Neurosci. 2010 Feb;31(4):770-8. doi: 10.1111/j.1460-9568.2010.07100.x.
- Background: PubMed 10209231Klimesch W. EEG alpha and theta oscillations reflect cognitive and memory performance: a review and analysis. Brain Res Brain Res Rev. 1999 Apr;29(2-3):169-95. doi: 10.1016/s0165-0173(98)00056-3.
- Background: PubMed 10924766Jelic V, Johansson SE, Almkvist O, Shigeta M, Julin P, Nordberg A, Winblad B, Wahlund LO. Quantitative electroencephalography in mild cognitive impairment: longitudinal changes and possible prediction of Alzheimer's disease. Neurobiol Aging. 2000 Jul-Aug;21(4):533-40. doi: 10.1016/s0197-4580(00)00153-6.
- Background: PubMed 24605806Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
- Background: PubMed 12557455Association for Applied Psychophysiology and Biofeedback. Template for developing guidelines for the evaluation of the clinical efficacy of psychophysiological interventions. Appl Psychophysiol Biofeedback. 2002 Dec;27(4):273-81. doi: 10.1023/a:1021061318355.
- Background: PubMed 20850552Zoefel B, Huster RJ, Herrmann CS. Neurofeedback training of the upper alpha frequency band in EEG improves cognitive performance. Neuroimage. 2011 Jan 15;54(2):1427-31. doi: 10.1016/j.neuroimage.2010.08.078. Epub 2010 Sep 17.
- 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.
Doron Todder, MD/PhD principal investigator
Beersheva Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TruScan Neurofeedback in people with Mild Cognitive Impairment and Alzheimer Disease, run by Beersheva Mental Health Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doron Todder, MD/PhD (972-8-6401767, doron.todder@pbsh.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory performance (time frame: 6 weeks). 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 NCT02987842, which also lists 10 linked publications.
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 13 Dec 2016.