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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Insomnia Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

Xijing Hospital of Air Force Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

cTBS group

sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Improvement rate of polysomnography monitoring index

Improvement rate of polysomnography monitoring index, including total sleep time, fall asleep time, wake time, sleep efficiency, sleep structure, etc.

Full Information

NCT ID

NCT05992285

First Posted

July 17, 2023

Last Updated

August 7, 2023

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05992285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cTBS group

Arm Type

Experimental

Arm Description

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.

Arm Title

sham group

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

transcranial magnetic stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At the end of 10 days of treatment

Secondary Outcome Measure Information:

Title

Improvement rate of polysomnography monitoring index

Description

Improvement rate of polysomnography monitoring index, including total sleep time, fall asleep time, wake time, sleep efficiency, sleep structure, etc.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wen Jiang

Phone

86-13991905538

Email

jiangwen@fmmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xinyao Liu

Phone

86-17792252198

Email

xuanxuanlxy@163.com

Facility Information:

Facility Name

Xijing Hospital of Air Force Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen Jiang

Phone

86-13991905538

Email

jiangwen@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xinyao Liu

Phone

86-17792252198

Email

xuanxuanlxy@163.com

12. IPD Sharing Statement

Plan to Share IPD

No

Insomnia Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial