Status:
COMPLETED
A Clinical Study of Theta Burst Stimulation (cTBS) in the Treatment of Insomnia Disorder Targeting the Dentate Nucleus of the Cerebellum
Lead Sponsor:
Xijing Hospital
Conditions:
Insomnia Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Insomnia disorder (ID) is a significant public health problem worldwide, with nearly a third of the general population experiencing insomnia symptoms in their lifetime. Therefore, finding a safe, effe...
Eligibility Criteria
Inclusion
- All participants aged from 18 to 60 years old; all participants met diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V), and scored \>10 on PSQI , ≤14 on the Hamilton Anxiety Scale (HAMA), and ≤17 on the Hamilton Depression Scale (HAMD); no sleep-affecting drugs were taken 1 month before or during the trial (non-prescription sleep medication, benzodiazepines or hypnotics, ect.); patients can cooperate to complete the treatment and related examination items; all subjects signed informed-consent forms before enrolling in the trial.
Exclusion
- The patient is unable to cooperate with the completion of treatment and examinations; there are other types of sleep disorders; a history of psychotropic drug or alcohol dependence or abuse in the last 2 years; have undertaken trans-meridian travel across more than two time zones or worked night shifts in the preceding one month or during the trial period; plan surgical treatment within 1 month before or during the trial; evidence of neurological or other physical diseases such as respiratory, cardiac, renal, hepatic, endocrinal diseases and other psychiatric diseases as assessed by clinical history, physical examination or routine laboratory tests; pregnancy or breastfeeding women; any contraindication for rTMS (including implanted metal and devices in the body, and history of epilepsy); concurrent other clinical trials; patient or family member withdraws informed-consent.
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05992285
Start Date
August 16 2023
End Date
October 29 2024
Last Update
November 25 2024
Active Locations (1)
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1
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China, 710032