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

NCT05992285 | Completed

• 1 other identifier: 20232190
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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, 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

Outcome Measures

Primary Outcomes (1)

• The reduction rate of the Pittsburgh Sleep Quality Index（PSQI） score

  The reduction rate of the Pittsburgh Sleep Quality Index (PSQI) score

  At the end of 10 days of treatment

Secondary Outcomes (1)

• Improvement rate of polysomnography monitoring index

  At the end of 10 days of treatment and 1 month follow-up

Study Arms (2)

cTBS group

EXPERIMENTAL

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.

Device: transcranial magnetic stimulation

sham group

SHAM COMPARATOR

The treatment of the sham group was the same as active group. The only difference was that the coil was flipped 180° in the sham group. The device also made the same sound but could not stimulate the brain.

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

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.

cTBS group; sham group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 15, 2023
• Study Start: August 16, 2023
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)