Skip to content

A randomized, controlled, double-blind trial of repetitive transcranial magnetic stimulation for irritability and insomnia in patients with autism spectrum disorder

A randomized, controlled, double-blind trial of repetitive transcranial magnetic stimulation for irritability and insomnia in patients with autism spectrum disorder

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049266
Enrollment
Unknown
Registered
2021-07-28
Start date
2021-08-16
Completion date
Unknown
Last updated
2022-08-30

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

Conditions

autism spectrum disorder (ASD)

Interventions

active group:repetitive transcranial magnetic stimulation
sham group:fake stimulus

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. The patient is in line with the diagnosis of ASD (preliminary clinical diagnosis using DSM-5 and CARS in the mental health center, on this basis, the gold standard for ASD diagnosis is adopted: autism diagnostic interview-revised (ADI-R) and autism diagnostic observation scale (ADOS) to diagnose ASD patients), meet the diagnostic criteria for insomnia in ICSD-3 (duration > 3 months; difficulty sleeping (sleep latency > 20 minutes or wake-up time > 20 minutes after falling asleep) at least 3 nights per week). 2. Aged between 3-13 years, no gender limit, can cooperate with the research. 3. Not taking any drugs that affect sleep or not changing the dose of drugs and taking new drugs during the trial period. 4. Both parents are alive and can cooperate to sign the informed consent and related scales.

Exclusion criteria

Exclusion criteria: 1.Those who have a history of epilepsy or severe head trauma, who have medical device implants (such as pacemakers, etc.) 2.Participants cannot cooperate 3.Severe neurologic or psychiatric disorders or medical conditions (e.g., skull defect and craniotomy) or other disorders likely to have an impact on sleep

Design outcomes

Primary

MeasureTime frame
Polysomnography;

Secondary

MeasureTime frame
Sleep diary;Abnormal behavior scale;Childhood autism rating scale;Social response scale;Repetitive stereotypes checklist (Revised);Children Sleep Habits Questionnaire;

Countries

China

Contacts

Public ContactTang Xiangdong

West China Hospital, Sichuan University

2372564613@qq.com+86 28 85422825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026