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Effect and mechanism of rtfMRI-NF regulating amygdala activity to improve insomnia disorder

Effect and mechanism of rtfMRI-NF regulating amygdala activity to improve insomnia disorder

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070360
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder

Interventions

experimental group:real neurofeedback
control group:pseudo feedback

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Demographic characteristics including age, occupation, income and marital status were recorded during the baseline period. After enrollment, they were randomly divided into experimental group and control group. Specific recruitment criteria are as follows: ? Diagnostic criteria for ID: meet the diagnostic criteria for ID in the American Diagnostic and Statistical Manual of Mental Disorders (Fifth edition) and the Chinese Classification and Diagnostic Criteria for Mental Disorders (Third edition), that is, the chief complaint of dissatisfaction with the quantity or quality of sleep, accompanied by the following (or more) related symptoms: A. Difficulty falling asleep; B. difficulty in maintaining sleep; C. Wake up early and cannot fall back asleep; D. Sleep disorders that cause clinically significant distress or impair social, occupational, educational, academic, behavioral, or other important functions; E. Difficulty sleeping at least 3 nights per week; F. Difficulty sleeping for at least 3 months; G. Difficulty sleeping despite adequate sleep opportunities; H. Insomnia is not better explained by another sleep-wake disorder and does not occur only in the course of another sleep-wake disorder (e.g., narcolepsy, breathing-related sleep disorders, circadian sleep-wake disorders, parasomnia); I. Insomnia cannot be attributed to the physical effects of a substance (e.g., abused drugs, medications); J. Co-existing mental disorders and physical conditions do not adequately explain the main complaint of insomnia. ? The inclusion criteria of patients with ID: A. The diagnostic criteria of ID in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) and the Classification and Diagnostic Criteria of Mental Disorders in China (Third Edition); B. In line with scale and objective criteria for PSG diagnosis ID, scale score required PSQI=7 points; C. Aged 18-60 years; D. Primary school education or above; E. Degree MRI routine brain examination is normal; F. Right-handed; G. Vision is normal/normal after correction.

Exclusion criteria

Exclusion criteria: Exclusion criteria: A. Insomnia caused by sleep disorders, such as obstructive sleep apnea syndrome, sleep periodic limb movement, etc.; B. severe suicidal ideation, severe mental disorder; C. Has or currently has a history of tobacco, alcohol and drug abuse; E. pregnancy; F. Contraindications to magnetic resonance imaging; G. claustrophobia; H. Taking drugs that affect brain function or blood flow within 3 weeks; I. History of mental and neurological diseases; History of head trauma; J. Hereditary diseases in the family; K. History of general anesthesia surgery; L. History of major physical illness.

Design outcomes

Primary

MeasureTime frame
resting-state brain activities;PSQI;20-item Toronto Alexithymia Scale,TAS-20;Positive Affect and Negative Affect Scale,PANAS;

Secondary

MeasureTime frame
HAMD-17;BDI;Polysomnography;

Countries

china

Contacts

Public ContactLiyongli

Henan Provincial People's Hospital

shyliyongli@126.com+86 13633812936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026