Neurofeedback Intervention for Preclinical Alzheimer's Disease

NCT ID: NCT04300933

Last Updated: 2020-03-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Subjective Cognitive Decline Neurofeedback Electroencephalogram

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Neurofeedback therapy

Fifty participants conduct neurofeedback daily for 5 days.

Group Type EXPERIMENTAL

Electroencephalogram-based neurofeedback

Intervention Type BEHAVIORAL

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.

Interventions

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Electroencephalogram-based neurofeedback

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Institute of Technology

OTHER

Sponsor Role collaborator

XuanwuH 2

OTHER

Sponsor Role lead

Responsible Party

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XuanwuH 2

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ying Han, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital of Capital Medical University

Locations

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Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HanYingsc3

Identifier Type: -

Identifier Source: org_study_id

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