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A randomised controlled double-blind clinical study of a new target-based rTMS modulating chronic insomnia

The role and neural mechanism of high-frequency rTMS modulation of chronic insomnia based on a new target in the left cerebellum

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087294
Enrollment
Unknown
Registered
2024-07-24
Start date
2024-07-25
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

chronic insomnia

Interventions

L-CursI/II real group:1x daily for 25min, 80% RMT, 1360 pulses, totally 2 weeks
L-CursI/II sham group:1x daily for 25min, 80% RMT, 1360 pulses, totally 2 weeks
RDPFC real group:1x daily for 25min, 100% RMT, 1360 pulses, totally 2 weeks

Sponsors

Shenzhen People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. gender is not limited; 2. 30-65 years old; 3. meets the diagnostic criteria for insomnia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 4. sleep disturbance occurs at least 3 nights per week and lasts for at least 3 months; and 5. PSQI score > 8.

Exclusion criteria

Exclusion criteria: 1. concurrent comorbidities of depression, bipolar disorder, epilepsy, chronic pain, sleep apnea syndrome, restless legs syndrome, and other disorders that may lead to insomnia; 2. HAMD = 20 or HAMA = 21; 3. severe liver, kidney, cardiovascular, cerebrovascular, and haematopoietic disorders and serious complications thereof; 3. women who are pregnant or breastfeeding; 4. chronic alcoholism or drug abuse; 5. Any contraindications to rTMS (including metals and devices implanted in the body and history of epilepsy); 6. Previous rTMS treatment within 1 year; 7. Severe cognitive impairment, language impairment or inability to cooperate with the treatment.

Design outcomes

Primary

MeasureTime frame
Scores of Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Scores of Insomnia Severity Index,ISI;Scores of Hamilton Depression Scale,HAMD;Scores of Hamilton Anxiety Scale, HAMA;Scores of Minimum Mental State Examination;Scores of Montreal Cognitive Assessment;

Countries

China

Contacts

Public ContactGuo Yi

Shenzhen People's Hospital

774654959@qq.com+86 185 2059 6397

Outcome results

None listed

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