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A multi-center randomized controlled trial assessing the effectiveness and safety of rTMS on bilateral parietal cortices

A multi-center randomized controlled trial assessing the effectiveness and safety of rTMS on bilateral parietal cortices

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100005
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Comorbid insomnia and cognitive impairment

Interventions

The real-rTMS group:14 sessions of 20 Hz rTMS applied over both parietal cortex per day(2400 pulses each time)
The sham-rTMS group:treated with sham rTMS like the real-rTMS group

Sponsors

West China Xiamen Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Right-handed. 2. Age range: 55-75 years old. 3. Years of education>=12 years; The education level is junior high school or above. 4. Meet the ICSD-3 diagnostic criteria for chronic insomnia. 5. PSQI score greater than 5 points. 6. Meet Petersen's diagnostic criteria. Criteria: (1) complaints of memory loss; (2) The course of the disease > 3 months; (3) Scale evaluation: Global deterioration scale (GDS) rating is 2~3; The clinical dementia rating scale (CDR) score was 0.5 points, and the memory test score was less than 1.5 standard deviations in the age and education matching control group, and the MMSE score was = 24, the MOCA score was < 26, and the daily living ability scale (ADL) score was higher than 26 points. (4) memory impairment was the main focus, and other cognitive domains remained relatively intact; (5) Ability to perform daily living remains normal; (6) Exclude dementia or any physical or mental disorder that can lead to brain dysfunction.

Exclusion criteria

Exclusion criteria: 1. Other neuropsychiatric diseases or brain structural abnormalities in the past. 2. History of severe heart, lung, liver, kidney, thyroid and other systemic diseases, history of infectious diseases such as syphilis and AIDS, history of severe brain trauma and surgery, history of heavy alcoholism, long-term use of benzodiazepines and drug addiction. 3. There are metal foreign bodies in the body, including stents, DBS treatment devices, pacemakers, etc.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale score;

Secondary

MeasureTime frame
Mini-Mental State Examination score;Montreal Cognitive Assessment Scale score;Insomnia Severity Index Scale score;HAMD-17;Hamilton Anxiety Scale score;Global Decline Scale score;Clinical Dementia Rating Scale score;Daily Living Ability Scale score;

Countries

China

Contacts

Public ContactZhong ZZheng

West China Xiamen Hospital of Sichuan University

zhengzhong1963@163.com+86 189 8060 1861

Outcome results

None listed

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