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Individualized fMRI based brain functional navigation rTMS for chronic insomnia treatment

Personalized Brain Function Subdivision navigation rTMS of chronic insomnia: spatio-temporal brain network mechanism and efficacy prediction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083537
Enrollment
Unknown
Registered
2024-04-26
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Chronic Insomnia

Interventions

pBFS navigational localization treatment group:pBFS navigational localization treatment
pBFS navigational localization sham stimulation group:pBFS navigational localization sham stimulation

Sponsors

Chengdu Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: CID patients were enrolled in the following criteria: (1) meet the diagnostic criteria of chronic insomnia disorder in the third edition of the International Classification of Sleep Disorders (ICSD-3); (2) Pittsburgh Sleep Quality Index (PSQI) score = 8; (3) persistent insomnia symptoms lasting for more than three months, including difficulty in falling asleep, poor sleep, or early awakening; (4) aged 18-60 years old and with education level = 9 years (junior high school or above); (5) not taking sleeping medication or other psychotropic drugs in the 2 weeks before enrollment; (6) Hamilton depression score (junior high school or above) -(iii) Insomnia symptoms lasting for more than three months, including difficulty in sleeping or deep sleep or early awakening; (iv) Age between 18 and 60 years old, and education level of =9 years (junior high school or above); (v) No sleeping pills or other psychotropic drugs within 2 weeks before enrollment; (vi) Hamilton Depression Scale (HAMD) score =17 to exclude depression, Hamilton Anxiety Scale (HAMA) score =14 to exclude anxiety disorders, and Mini-Mental State Examination (MMSE) score =26 to exclude cognitive disorders. Healthy subjects were enrolled based on the following criteria: ? Healthy, no complaints of sleep disorders, mood disorders and cognitive disorders; ? Normal neurological examination; ? PSQI <5, MMSE =26, HAMD <7 and HAMA <7; and ? Age, gender and education level matched with the patient group.

Exclusion criteria

Exclusion criteria: Exclusion criteria for CID patients and healthy subjects: ? history of disorders of consciousness; ? other types of sleep disorders; ? taking medications that can cause insomnia (e.g., steroids, etc.); ? history of other medical conditions: e.g., CNS infections, head injuries, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease, intracranial tumors, hypothyroidism, diabetes mellitus and other somatic disorders; history of depression, bi-directional disorders, anxiety disorders, Schizophrenia, schizophrenia, personality change and other psychiatric disorders; ? history of alcohol dependence; ? combination of serious heart, liver, kidney, brain and hematopoietic system diseases; ? pregnancy, lactation; ? electronic and metal device implantation and other MRI scans and rTMS contraindications to treatment; ? other researchers believe that do not meet the conditions of the enrollment.

Design outcomes

Primary

MeasureTime frame
insomnia related scale (PSQI and ISI);

Secondary

MeasureTime frame
Emotion Related Scale;Blood test;

Countries

China

Contacts

Public ContactLiang Gong

Chengdu Second People's Hospital

suegongliang@hotmail.com+86 173 6025 1891

Outcome results

None listed

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