Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's Disease
NCT ID: NCT02987842
Last Updated: 2016-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-12-31
2017-12-31
Brief Summary
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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
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1. Memory complaint, preferably corroborated by an informant.
2. Objective memory impairment for age and education.
3. Largely intact general cognitive function.
4. Essentially preserved activities of daily living.
5. 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
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)
TruScan Neurofeedback
Neurofeedback and quantitative EEG system
Sham group
Patients in the sham group will receive feedback using the TruScan Neurofeedback system for electrical static activity of a disconnected electrode.
TruScan Neurofeedback
Neurofeedback and quantitative EEG system
Interventions
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TruScan Neurofeedback
Neurofeedback and quantitative EEG system
Eligibility Criteria
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Inclusion Criteria
* Age \> 50
Exclusion Criteria
* Any axis 1 type disorder
50 Years
ALL
No
Sponsors
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Beersheva Mental Health Center
OTHER_GOV
Responsible Party
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Doron Todder
Head of anxiety unit
Principal Investigators
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Doron Todder, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Beersheva Mental Health Center
Locations
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Beer-Sheva Mental Health Center
Beersheba, , Israel
Countries
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Central Contacts
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References
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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.
Becerra 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.
Jin 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.
Panza 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.
Ros 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.
Klimesch 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.
Jelic 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.
Petersen 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.
Association 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.
Zoefel 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.
Other Identifiers
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BeershevaMHC
Identifier Type: -
Identifier Source: org_study_id