Neurofeedback Intervention for Preclinical Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer Disease; Neurofeedback; Electroencephalogram; Subjective Cognitive Decline
• Interventions: Behavioral: Electroencephalogram-based neurofeedback

• Registration Number: NCT04300933
• Lead Sponsor: XuanwuH 2

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Last Update Submitted: 2020-03-06
• Study First Posted: 2020-03-09
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurofeedback therapy	Electroencephalogram-based neurofeedback	Fifty participants conduct neurofeedback daily for 5 days.

Primary Outcome Measures

Name	Time	Method
Changes of Auditory Verbal Learning Test (AVLT) score	Five days	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.

Trial Locations

Locations (1)

Department of Neurolgy, Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China