Neurofeedback Intervention for Preclinical Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300933
• Other study ID #: HanYingsc3
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Electroencephalogram
• Neurofeedback
• Subjective Cognitive Decline

Intervention

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.

Locations

Country	Name	City	State
China	Department of Neurolgy, Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
XuanwuH 2	Beijing Institute of Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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