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

NCT05992285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-11-25

No results posted yet for this 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.

Conditions

  • Insomnia Disorder

Interventions

DEVICE

transcranial magnetic stimulation

the intensity of stimulus was 80% Resting motor threshold(RMT); the frequency of trains was 50 Hz and the number of pulses was three; and the frequency of intertrain intervals was 5 Hz and pulses number was 200. Two groups were repeatedly stimulated in the dentate nucleus of bilateral cerebellum, the interval of each group was 5min, and the number of stimulation pulses at each site was 1200.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2024-10-29
Completion
2024-10-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05992285 on ClinicalTrials.gov