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Research on Precision Neurological Intervention for Insomnia Disorder Based on Glymphatic System and Brain Network Mechanisms

Research on Precision Neurological Intervention for Insomnia Disorder Based on Glymphatic System and Brain Network Mechanisms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119337
Enrollment
Unknown
Registered
2026-02-25
Start date
2026-02-25
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

insomnia disorder

Interventions

Sham Stimulation Control Group:Sham stimulation was administered using the Cool?B65 A/P (Active/Placebo) coil of the MagPro R30 transcranial magnetic stimulator.
rTMS Treatment Group (Insomnia Disorder):repetitive Transcranial Magnetic Stimulation

Sponsors

Wuxi Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Inclusion criteria for the insomnia disorder group at baseline: 1) Chinese nationality, Han ethnicity, right-handed, both genders eligible, aged 18–60 years with at least primary school education, and written informed consent obtained from the patients; 2) First clinical visit primarily for insomnia symptoms, meeting the DSM-5 diagnostic criteria for insomnia disorder as assessed by the SCID-5; 3) Subjective complaint of sleep disturbance, with a PSQI score > 10; 4) Hamilton Depression Rating Scale (24-item version) score 85; 6) No family history of psychiatric disorders among first-degree relatives.

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria for the insomnia disorder group: 1) Meeting diagnostic criteria for any psychiatric disorder other than insomnia disorder as assessed by the Structured Clinical Interview for DSM-5 (SCID-5); 2) Presence of organic brain disorders or severe, unstable somatic diseases (e.g., cardiac conditions); 3) History of epilepsy, febrile seizures, or coma (with loss of consciousness exceeding 5 minutes); 4) History of alcohol or substance abuse; 5) Contraindications to sleep electroencephalography monitoring; 6) Women who are pregnant or breastfeeding; 7) Wechsler Intelligence Scale score < 70. 2.Exclusion criteria for the healthy control group: 1) Wechsler Intelligence Scale score < 70; 2) Presence of organic brain disorders or severe, unstable somatic diseases (e.g., cardiac conditions); 3) History of epilepsy, febrile seizures, or coma (with loss of consciousness exceeding 5 minutes); 4) History of alcohol or substance abuse; 5) Contraindications to sleep electroencephalography monitoring; 6) Women who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Glymphatic System Function;Electroencephalography;Change in Pittsburgh Sleep Quality Index Total Score;General demographic information;

Secondary

MeasureTime frame
Hamilton Depression Scale Total Score;Hamilton Anxiety Scale Total Score;Composite Cognitive Score;

Countries

China

Contacts

Public ContactShan Zhangyan

Wuxi Mental Health Center

szysaxiaokai@163.com+86 510 8325 0076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026