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To explore the treatment of chronic insomnia disorder with repeative transcranial magnetic stimulation under image navigation system

To explore the treatment of chronic insomnia disorder with repeative transcranial magnetic stimulation under image navigation system - To explore the treatment of chronic insomnia disorder with rTMS under image navigation system

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091978
Enrollment
Unknown
Registered
2024-11-06
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Chronic Insomnia

Interventions

Intervention group:TMS
Pseudo stimulation group:sham stimulation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chronic insomnia disorder case group: diagnosed outpatient/inpatient with ICSD-3 chronic insomnia disorder, aged 14-65 years, dextromanuality; 2. The subjects meet the diagnostic criteria of ICSD-3 chronic insomnia disorder; 3. ISI>=8 points; 4. The subjects without physical therapy (such as MECT, TMS, acupuncture, etc) in the past 6 months; 5. The subjects havent use the drugs of sedative-hypnotic, antidepressants, antipsychotics, mood stabilizers, or others that effect on the central nervous system at least 4 weeks; 6. The subjects are non-shift workers; 7. The subjects with chronic insomnia = 5 years.

Exclusion criteria

Exclusion criteria: 1. The subjects were diagnosed as mental disease currently or previously according to MINI; 2. The subjects education period < 5 years or IQ < 90 points; 3. The subjects travelled across time zones within 3 months; 4. The subjects with the habit of consuming probiotics and prebiotic products; 5. The subjects suffered from nervous system disease, trauma, chronic physical diseases, brain organic diseases or tumor. 6. The patients had some sleep disorders (OSA, PLMS, RLS, etc) but except insomnia 7. The subjects who intake alcohol within 1 week before enrolling; 8. The subjects who consume coffee in the afternoon before the experiment; 9. The subjects contraindicated to MRI.

Design outcomes

Primary

MeasureTime frame
PSQI;ISI;Polysomnography (PSG);

Secondary

MeasureTime frame
Sleep monitoring bracelet;fMRI;PHQ-15;PHQ-9;GAD-7;MoCA;HAMA;HAMD-17;Stanford Sleepiness Scale;Beck Anxiety Inventory;Beck Depression Inventory;PANAS;Morningness-Eveningness Questionnaire;Emotion Regulation Questionnaire;Social Interaction Questionnaire;Liebowitz Social Anxiety Scale;Interpersonal Motivational System Scale;Childhood Trauma Questionnaire;Subjective Socioeconomic Status Scale;Self-Control Scale;UCLA Loneliness Scale;VFT;FFT;Treasure Hunt Maze Game Test;Electroencephalography (EEG); Near-Infrared Spectroscopy (NIRS); Magnetoencephalography (MEG);

Countries

China

Contacts

Public ContactJun Zhang

West China Hospital of Sichuan University

1025159956@qq.com+86 189 8060 2251

Outcome results

None listed

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