Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

Not Applicable

Recruiting

• Conditions: Eating Behavior; Schizophrenia; Metabolic Disturbance; Transcranial Magnetic Stimulation
• Interventions: Device: accelerated theta burst stimulation; Device: Sham stimulation

• Registration Number: NCT05358899
• Lead Sponsor: Central South University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Study Start: 2022-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-21
• Primary Completion: 2022-12-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real stimulation	accelerated theta burst 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.
Sham stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change of body weight	from baseline to 6 weeks	the change of participants weight
Change of body mass index	from baseline to 6 weeks	the change of participants BMI

Secondary Outcome Measures

Name	Time	Method
Barrat impulsiveness scale	from baseline to 6 weeks	four domains regarding impulsiveness, from 26-104 higher score means higher impulse.
Positive and Negative syndrome rating scale	from baseline to 6 weeks	Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.
Three Factor Eating Questionnaire	from baseline to 6 weeks	three domain regarding eating behavior, from 0-51, higher score means better.
Food picture stimulation Event-related potentials	from baseline to 6 weeks	Several components of event-related potentials were analyzed regarding various cognitive processes. The data were analyzed using previously widely used pipelines to extract the characters of ERP components, for example, P3 and LPP, and compare its difference within groups and between groups through time. ERP analysis will be conducted using EEGLAB and FieldTrip in MATLAB, and statistic analysis will be conducted using R studio and SPSS.
Self-Control Scale	from baseline to 6 weeks	five domains regarding self control ability, from 36-180 higher score means better self control.

Trial Locations

Locations (1)

Second Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China