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Efficacy of Electroencephalography (EEG) Neurofeedback (NF) of Motor Sensory Cortex as an Add-on Treatment for Drug-naïve Anxiety Disorder: A Randomized, Double-blind, Sham-controlled Trial
The aim of this study is to assess the efficacy of electroencephalography (EEG) neurofeedback (NF) as an Add-on Treatment for the Anxiety disorder. Meanwhile, evaluate the effect of EEG-NF on cognitive function of Anxiety patients. Furthermore, the investigators will examine the changes in cortisol, gut microbiome and some biomarkers. The hypothesis of this study is that EEG-NF alleviate the anxiety symptoms and improve the cognitive function of Anxiety disorder patients with regulating attention response.
This is a randomized, double-blind, sham-controlled study using electroencephalography (EEG) neurofeedback (NF) for 2-week treatment. Participants were randomly assigned 1:1 to NF group or sham-control group. The NF group performed six NF sessions every other day in about two weeks. The feedback value of the NF group was about SMR band, while in the control group was pseudo-random numbers. Apart from studying the effects of EEG-NF on severity of anxiety and cognitive function, the secondary outcomes are to examine biomarkers related to inflammatory activity. Scale assessments are performed before the initiation of treatment, week 1, week 2. The Digit Span test, Go/No-Go task Collection of blood, excrement and saliva takes place at two time points, at the baseline, week 2.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Tianjin Anding Hospital
Tianjin, China
Start Date
September 10, 2019
Primary Completion Date
October 1, 2022
Completion Date
November 1, 2023
Last Updated
October 19, 2021
60
ESTIMATED participants
SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics
DRUG
Neurofeedback system
DEVICE
Lead Sponsor
Tianjin Anding Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT07310264