Neurofeedback Intervention for Preclinical Alzheimer's Disease

NCT04300933 | Completed

• 1 other identifier: HanYingsc3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Subjective Cognitive Decline; Neurofeedback; Electroencephalogram

Keywords

Subjective cognitive decline; Intervention; Neurofeedback

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Neurofeedback therapy

EXPERIMENTAL

Fifty participants conduct neurofeedback daily for 5 days.

Behavioral: Electroencephalogram-based neurofeedback

Interventions

Electroencephalogram-based neurofeedback 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.

Neurofeedback therapy

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• XuanwuH 2: lead
• Beijing Institute of Technology: collaborator

Study Sites (1)

Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ying Han, PhD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 9, 2020
• Study Start: April 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: December 31, 2019
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When summary data are published or starting 6 months after publication.
• Access Criteria: The information of neuropsychological tests data will be shared.

Locations

CN (1)