rTMS on Appetite and Cognitive Function in Schizophrenia

• Sponsor: Central South University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04714970
• Collaborator: Shanghai Mental Health Center (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.4
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: iTBS; Device: Shame stimulation	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia
• Actual Study Start Date: Apr 20, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iTBS stimulation The participants randomized into experimental group will receive iTBS stimulation of dlPFC 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.	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.
Sham Comparator: Sham stimulation The participants randomized intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.	Device: Shame stimulation; TMS coil vertical to the brain surface, with same protocol as iTBS

Outcome Measures

Primary Outcome Measures

1. Change of Appetite [Change from Baseline to 6days and 36days]

   Three-Factor Eating Questionnaire

2. Change of MCCB [Change from Baseline to 6days and 36days]

   The MATRICS™ Consensus Cognitive Battery

3. Change of ERP [Change from Baseline to 6days and 36days]

   Food picture ERP recorded by EEG

Secondary Outcome Measures

1. Change of fasting glucose [Change from Baseline to 6days and 36days]

   in mmol/l

2. Change of fasting insulin level [Change from Baseline to 6days and 36days]

   in mmol/l

3. Change of Triglyceride [Change from Baseline to 6days and 36days]

   in mmol/l

4. Change of Total Cholesterol [Change from Baseline to 6days and 36days]

   in mmol/l

5. Change of LDL [Change from Baseline to 6days and 36days]

   in mmol/l

6. Change of HDL [Change from Baseline to 6days and 36days]

   in mmol/l

7. Change of BMI [Change from Baseline to 6days and 36days]

   weight and height will be combined to report BMI in kg/m^2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central South University	Changsha	Hunan	China	410000

Sponsors and Collaborators

• Central South University
• Shanghai Mental Health Center

Investigators

• Principal Investigator: Renrong Wu, Prof, Central South University Psychiatry Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renrong Wu, Professor, Central South University
• ClinicalTrials.gov Identifier: NCT04714970
• Other Study ID Numbers: WU2021TMS
• First Posted: Jan 20, 2021
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Renrong Wu, Professor, Central South University: Schizophrenia; rTMS; Appetite; Cognitive Function
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Apr 29, 2022