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NCT Number: NCT04300933

Neurofeedback Intervention for Preclinical Alzheimer's Disease

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.

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Key information

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes of Auditory Verbal Learning Test (AVLT) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

XuanwuH 2

Other

Collaborators

  • Beijing Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2020
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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