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Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's Disease

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TruScan Neurofeedback
Sponsored by
Beersheva Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Alzhiemer's disease, Neurofeedback, EEG

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of either mild cognitive impairment or mild Alzheimer's disease
  • Age > 50

Exclusion Criteria:

  • Active neurological disorder
  • Any axis 1 type disorder

Sites / Locations

  • Beer-Sheva Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Sham group

Arm Description

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)

Patients in the sham group will receive feedback using the TruScan Neurofeedback system for electrical static activity of a disconnected electrode.

Outcomes

Primary Outcome Measures

Memory performance
improvement in memory performance

Secondary Outcome Measures

General cognitive performance improvement
improvement in other cognitive domains
qEEG
Improvement in upper alpha to lower alpha power ratio and of peak alpha frequency

Full Information

First Posted
December 7, 2016
Last Updated
December 12, 2016
Sponsor
Beersheva Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02987842
Brief Title
Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's Disease
Official Title
Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beersheva Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease
Keywords
Mild cognitive impairment, Alzhiemer's disease, Neurofeedback, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Patients in the sham group will receive feedback using the TruScan Neurofeedback system for electrical static activity of a disconnected electrode.
Intervention Type
Device
Intervention Name(s)
TruScan Neurofeedback
Intervention Description
Neurofeedback and quantitative EEG system
Primary Outcome Measure Information:
Title
Memory performance
Description
improvement in memory performance
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
General cognitive performance improvement
Description
improvement in other cognitive domains
Time Frame
6 weeks
Title
qEEG
Description
Improvement in upper alpha to lower alpha power ratio and of peak alpha frequency
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of either mild cognitive impairment or mild Alzheimer's disease Age > 50 Exclusion Criteria: Active neurological disorder Any axis 1 type disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doron Todder, MD/PhD
Phone
972-8-6401767
Email
doron.todder@pbsh.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yotam Lavy, M.Sc
Phone
972-8-6401767
Email
lavy@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron Todder, MD/PhD
Organizational Affiliation
Beersheva Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beer-Sheva Mental Health Center
City
Beer-Sheva
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17366280
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Neurofeedback as a Novel Treatment for Mild Cognitive Impairment & Early Alzheimer's Disease

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