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Exploring the Efficacy and Safety of Bilateral Theta Burst Stimulation in Patients with Chronic Insomnia Disorder: A Randomized, Double-Blind, Sham-Controlled Study

Exploring the Efficacy and Safety of Bilateral Theta Burst Stimulation in Patients with Chronic Insomnia Disorder: A Randomized, Double-Blind, Sham-Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107562
Enrollment
Unknown
Registered
2025-08-14
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Chronic insomnia disorder

Interventions

Bilateral DLPFC group.:Bilateral TBS stimulation at the right dorsolateral prefrontal cortex (DLPFC) (F4 position according to the 10-20 system) and left DLPFC (F3 position according to the 10-20 syst
intertrain frequency 5Hz, 200 trains
stimulation duration 40 seconds, interstimulus interval 8 seconds, 1 repetition, total of 600 pulses), followed by left iTBS (intratrain frequency 50Hz, 3 pulses per train
intertrain frequency 5Hz, 10 trains
stimulation duration 2 seconds, interstimulus interval 8 seconds, 20 repetitions, total of 600 pulses). After a 15-minute interval, the above procedure is repeated, with alternating TBS stimulation of
Right DLPFC group : Bilateral TBS stimulation at the right dorsolateral prefrontal cortex (DLPFC) (F4 position according to the 10-20 system) at an intensity of 70% RMT. The right side is subjected to
stimulation duration 40 seconds, interstimulus interval 8 seconds, 1 repetition, total of 600 pulses). After a 15-minute interval, the above procedure is repeated, with TBS stimulation of the right DL
Sham stimulation group.:The sham stimulation coil has the same shape and sound as the real stimulation coil, but does not emit a magnetic field. The sham stimulation protocol is randomly selected from

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic insomnia disorder as defined in the International Classification of Sleep Disorders, Third Edition (ICSD-3); (2) Pittsburgh Sleep Quality Index (PSQI) score>= 8, Insomnia Severity Index (ISI) score >= 10; (3) Stable vital signs, no severe aphasia, visual, auditory, or cognitive impairments, able to cooperate in completing the study protocol; (4) Aged 18-65 years, right-handed; (5) Voluntarily participate and sign the informed consent form, or consent may be waived.

Exclusion criteria

Exclusion criteria: (1) A history of rTMS, transcranial electrical stimulation (tES), or other treatments in the past month; (2) A history of brain organic diseases, brain injury, stroke, severe mental disorders, craniotomy, or cranioplasty; (3) Implantation of metallic or electronic devices (e.g., pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.); (4) A history of substance abuse (caffeine, nicotine, and alcohol); (5) Severe aphasia that prevents the completion of the assessment; (6) Other serious diseases that may affect the study.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Digit Span Test;n-back;

Secondary

MeasureTime frame
Insomnia Severity Index;Epworth Sleepiness Scale;Self-Rating Anxiety Scale;Hamilton Anxiety Scale;Self-Rating Depression Scale;Hamilton Depression Rating Scale;Rivermead Behavioural Memory Test;Functional Near-Infrared Spectroscopy;Activity Monitor;

Countries

China

Contacts

Public ContactZhang Liying

The Third Affiliated Hospital of Sun Yat-sen University

zhangliying_good@126.com+86 136 3240 1780

Outcome results

None listed

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