Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358899
• Other study ID #: wu2022acTBS
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2022
• Source: Central South University
• Contact: Renrong Wu, Prof
• Phone: 15874179855
• Email: wurenrong[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior
• Metabolic Disturbance
• Schizophrenia
• Transcranial Magnetic Stimulation

Intervention

Device:
• 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).
• 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.

Locations

Country	Name	City	State
China	Second Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body weight	the change of participants weight	from baseline to 6 weeks
Primary	Change of body mass index	the change of participants BMI	from baseline to 6 weeks
Secondary	Positive and Negative syndrome rating scale	Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.	from baseline to 6 weeks
Secondary	Three Factor Eating Questionnaire	three domain regarding eating behavior, from 0-51, higher score means better.	from baseline to 6 weeks
Secondary	Barrat impulsiveness scale	four domains regarding impulsiveness, from 26-104 higher score means higher impulse.	from baseline to 6 weeks
Secondary	Self-Control Scale	five domains regarding self control ability, from 36-180 higher score means better self control.	from baseline to 6 weeks
Secondary	Food picture stimulation Event-related potentials	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.	from baseline to 6 weeks