Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

NCT ID: NCT05358899

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-05-01

Brief Summary

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cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.

Detailed Description

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Conditions

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Schizophrenia Metabolic Disturbance Eating Behavior Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Quadro-blind clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The participants, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.

Study Groups

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Real stimulation

Participants in the real stimulation group will receive accelerated cTBS with 1800 stimulation per session for 10 consecutive days, 5 sessions per day with a gap at least one hour, 50 sessions in total. The stimulation will be conducted at left M1 area.

Group Type EXPERIMENTAL

accelerated theta burst stimulation

Intervention Type DEVICE

cTBS was administered at 80% of each participant's M1 area in a burst-firing pattern (3 pulses at 50 Hz) with a repetition frequency of 5 Hz (200 ms intervals). During each session, participants received 1800 pulses (120 s).

Sham stimulation

Participants in the sham stimulation group will receive the stimulation with coil vertical to the surface with other settings same as the real stimulation group.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Similar process with the accelerated theta burst stimulation with the coil 90 degrees tilted to the surface of the scalp, which could produce identical sound and vibration while avoiding real magnetic stimulation.

Interventions

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accelerated theta burst stimulation

cTBS was administered at 80% of each participant's M1 area in a burst-firing pattern (3 pulses at 50 Hz) with a repetition frequency of 5 Hz (200 ms intervals). During each session, participants received 1800 pulses (120 s).

Intervention Type DEVICE

Sham stimulation

Similar process with the accelerated theta burst stimulation with the coil 90 degrees tilted to the surface of the scalp, which could produce identical sound and vibration while avoiding real magnetic stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with schizophrenia in accordance with DSM-5
* BMI over 24
* Accepting antipsychotics stable treatment for more then 2 months

Exclusion Criteria

* Diagnosed with other mental disease in accordance with DSM-5
* Comorbid with other severe physiological disease
* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
* Drug or alcohol abuse
* Pregnant or lactating Contraindication to rTMS
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Renrong Wu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Renrong Wu, Prof

Role: CONTACT

15874179855

Facility Contacts

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Dongyu Kang, MD

Role: primary

+86 13787142461

Other Identifiers

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wu2022acTBS

Identifier Type: -

Identifier Source: org_study_id

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