rTMS on Appetite and Cognitive Function in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04714970
• Other study ID #: WU2021TMS
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.

Description:

The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients with schizophrenia in accordance with DSM-5

• Commorbid with significant weight gain after antipsychotics

• Informed Consent

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

• Schizophrenia

Intervention

Device:
• iTBS
Intermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total.
• Shame stimulation
TMS coil vertical to the brain surface, with same protocol as iTBS

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Central South University	Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Appetite	Three-Factor Eating Questionnaire	Change from Baseline to 6days and 36days
Primary	Change of MCCB	The MATRICS™ Consensus Cognitive Battery	Change from Baseline to 6days and 36days
Primary	Change of ERP	Food picture ERP recorded by EEG	Change from Baseline to 6days and 36days
Secondary	Change of fasting glucose	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Change of fasting insulin level	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Change of Triglyceride	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Change of Total Cholesterol	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Change of LDL	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Change of HDL	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Change of BMI	weight and height will be combined to report BMI in kg/m^2	Change from Baseline to 6days and 36days