NCT04562324

Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anxiety Disorder
• Healthy

Interventions

Type	Name	Description
DRUG	SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics	Medications to relieve anxiety
DEVICE	Neurofeedback system	EEG-neurofeedback is an operant conditioning procedure in which people learn to improve the brain's functional activity and used as a way to effect long-term change in abnormal brain activity thus alter corresponding cognitive function. In addition, its potential to be used to elucidate the mechanisms underlying psychopathology by evaluating the subjective effect of the modulation of specific brain areas has become apparent. Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks

Timeline

• Start date: 2019-09-10
• Primary completion: 2022-10-01
• Completion: 2023-11-01
• First posted: 2020-09-24
• Last updated: 2021-10-19

Locations

1 site across 1 country: China