A Clinical Study of Theta Burst Stimulation (cTBS) in the Treatment of Insomnia Disorder Targeting the Dentate Nucleus of the Cerebellum

Last updated: November 21, 2024
Sponsor: Xijing Hospital
Overall Status: Completed

Phase

N/A

Condition

Anxiety Disorders

Treatment

transcranial magnetic stimulation

Clinical Study ID

NCT05992285
20232190
  • Ages 18-60
  • All Genders

Study 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, effective, and easy-to-use non-pharmacological method for treating ID is urgent. Repetitive transcranial magnetic stimulation (rTMS) has been used to varying degrees in many neurological and psychiatric diseases and has broad application prospects for treating ID.θ-burst stimulation is characterized by cluster stimulation.Continuous stimulation (cTBS) mainly has inhibitory effects on the cortex. The inhibition of motor-evoked potentials can last for 60 minutes, which is longer-lasting, has a lower stimulation intensity, and is shorter in duration than traditional rTMS. There are no reports on clinical studies of cTBS treatment for ID. So far, sleep research has mainly focused on the interconnections between the neocortex and subcortical structures, while cerebellar activity has been largely overlooked.The mechanism of rTMS treatment for insomnia with the cerebellum as the target is unclear. This study proposes to apply cTBS mode to the cerebellar dentate nucleus for rTMS treatment in patients with ID to explore its effectiveness and safety in improving insomnia disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants aged from 18 to 60 years old; all participants met diagnosticcriteria for insomnia disorder according to the Diagnostic and Statistical Manual ofMental Disorders-V (DSM-V), and scored >10 on PSQI , ≤14 on the Hamilton AnxietyScale (HAMA), and ≤17 on the Hamilton Depression Scale (HAMD); no sleep-affectingdrugs were taken 1 month before or during the trial (non-prescription sleepmedication, benzodiazepines or hypnotics, ect.); patients can cooperate to completethe treatment and related examination items; all subjects signed informed-consentforms before enrolling in the trial.

Exclusion

Exclusion Criteria:

  • The patient is unable to cooperate with the completion of treatment andexaminations; there are other types of sleep disorders; a history of psychotropicdrug or alcohol dependence or abuse in the last 2 years; have undertakentrans-meridian travel across more than two time zones or worked night shifts in thepreceding one month or during the trial period; plan surgical treatment within 1month before or during the trial; evidence of neurological or other physicaldiseases such as respiratory, cardiac, renal, hepatic, endocrinal diseases and otherpsychiatric diseases as assessed by clinical history, physical examination orroutine laboratory tests; pregnancy or breastfeeding women; any contraindication forrTMS (including implanted metal and devices in the body, and history of epilepsy);concurrent other clinical trials; patient or family member withdrawsinformed-consent.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: transcranial magnetic stimulation
Phase:
Study Start date:
August 16, 2023
Estimated Completion Date:
October 29, 2024

Connect with a study center

  • First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi 710068
    China

    Site Not Available

  • Xi'an Hospital of Traditional Chinese Medicine

    Xi'an, Shaanxi 710021
    China

    Site Not Available

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi 710100
    China

    Site Not Available

  • Xi'an NO.1 Hospital

    Xi'an, Shaanxi 710002
    China

    Site Not Available

  • Xijing Hospital of Air Force Military Medical University

    Xi'an, Shaanxi 710032
    China

    Site Not Available

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