Neurofeedback Intervention for Preclinical Alzheimer's Disease

Effects of Electroencephalogram-based Neurofeedback on Cognition in Adults With Subject Cognitive Decline

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Electroencephalogram; Neurofeedback; Subjective Cognitive Decline
• Intervention / Treatment: Behavioral: Electroencephalogram-based neurofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback therapy; Fifty participants conduct neurofeedback daily for 5 days.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Five days

Collaborators and Investigators

• Sponsor: XuanwuH 2
• Collaborators: Beijing Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Intervention; Neurofeedback; Subjective cognitive decline
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: HanYingsc3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No