Back to resultsNeurofeedback Intervention for Preclinical Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Subjective Cognitive Decline, Neurofeedback
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroencephalogram-based neurofeedback
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease focused on measuring Subjective cognitive decline, Intervention, Neurofeedback
Eligibility Criteria
Inclusion Criteria:
- 50-79 years old, right-handed and Mandarin-speaking subjects;
- self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
- normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests;
- concerns (worries) associated with memory complaint;
- failure to meet the criteria for MCI or dementia
Exclusion Criteria:
- a history of stroke;
- major depression (Hamilton Depression Rating Scale score > 24 points);
- other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
- a history of psychosis or congenital mental growth retardation.
Sites / Locations
- Department of Neurolgy, Xuanwu Hospital of Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurofeedback therapy
Arm Description
Fifty participants conduct neurofeedback daily for 5 days.
Outcomes
Primary Outcome Measures
Changes of Auditory Verbal Learning Test (AVLT) score
After intervention for five days, the investigators will compare baseline and post-therapy memory changes based on Auditory Verbal Learning Test (AVLT) scale, in order to investigate the therapeutic effectiveness of neurofeedback. The scale of AVLT focuses on the memory domain, especially AVLT-long delayed memory, with cut- off points as 5 (50-59 years old), 4 (60-69 years old), 3 (70-79 years old) and AVLT-recognition, with cut-off points as 20 (50-59 years old), 19 (60-69 years old), 18 (70-79 years old). Higher scores mean a better outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT04300933
First Posted
March 6, 2020
Last Updated
March 6, 2020
Sponsor
XuanwuH 2
Collaborators
Beijing Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT04300933
Brief Title
Neurofeedback Intervention for Preclinical Alzheimer's Disease
Official Title
Effects of Electroencephalogram-based Neurofeedback on Cognition in Adults With Subject Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
XuanwuH 2
Collaborators
Beijing Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective pharmacologic therapy for this disease. Electroencephalogram-based neurofeedback is considered as a potentially treatment strategy. In this project, the investigators aim to investigate the effectiveness of neurofeedback therapy on cognition for individuals with subjective cognitive decline (SCD). Participants will receive electroencephalogram-based neurofeedback therapy once a day for successive five days. Then, the investigators will evaluate the changes of memory function between baseline and post-therapy visits.
Detailed Description
Currently, there has been no effective therapy for Alzheimer's disease (AD). Electroencephalogram-based neurofeedback is now considered as a potentially intervention and may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of neurofeedback on cognition for subjective cognitive decline (SCD).
Fifty participants with SCD will be recruited in this clinical trial. At baseline, neuropsychological tests are conducted. Participants will receive electroencephalogram-based neurofeedback therapy once a day for successive five days. After that, the investigators will evaluate the changes of memory measures, which is the primary outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Subjective Cognitive Decline, Neurofeedback, Electroencephalogram
Keywords
Subjective cognitive decline, Intervention, Neurofeedback
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback therapy
Arm Type
Experimental
Arm Description
Fifty participants conduct neurofeedback daily for 5 days.
Intervention Type
Behavioral
Intervention Name(s)
Electroencephalogram-based neurofeedback
Intervention Description
In this project, SCD participants will receive electroencephalogram-based neurofeedback therapy, once a day, for 5 days. Then, the investigators will compare their memory changes between baseline and post-therapy visits.
Primary Outcome Measure Information:
Title
Changes of Auditory Verbal Learning Test (AVLT) score
Description
After intervention for five days, the investigators will compare baseline and post-therapy memory changes based on Auditory Verbal Learning Test (AVLT) scale, in order to investigate the therapeutic effectiveness of neurofeedback. The scale of AVLT focuses on the memory domain, especially AVLT-long delayed memory, with cut- off points as 5 (50-59 years old), 4 (60-69 years old), 3 (70-79 years old) and AVLT-recognition, with cut-off points as 20 (50-59 years old), 19 (60-69 years old), 18 (70-79 years old). Higher scores mean a better outcome.
Time Frame
Five days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50-79 years old, right-handed and Mandarin-speaking subjects;
self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests;
concerns (worries) associated with memory complaint;
failure to meet the criteria for MCI or dementia
Exclusion Criteria:
a history of stroke;
major depression (Hamilton Depression Rating Scale score > 24 points);
other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
cognitive impairment caused by traumatic brain injury;
systemic diseases, such as thyroid dysfunction, syphilis and HIV;
a history of psychosis or congenital mental growth retardation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Han, PhD
Organizational Affiliation
Xuanwu Hospital of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurolgy, Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The information of neuropsychological tests will be shared with other researchers.
IPD Sharing Time Frame
When summary data are published or starting 6 months after publication.
IPD Sharing Access Criteria
The information of neuropsychological tests data will be shared.
Learn more about this trial
Neurofeedback Intervention for Preclinical Alzheimer's Disease
We'll reach out to this number within 24 hrs