cTBS on First-episode Drug Naive Patients With Schizophrenia

Sponsor

Central South University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05086133

Collaborator

Shanghai Mental Health Center (Other)

Enrollment

Location

Arms

8.3

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, 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 cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: transcranial magnetic stimulation Device: sham stimulation	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1 group for intervention and 1 group for sham stimulation1 group for intervention and 1 group for sham stimulation

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.

Primary Purpose:

Treatment

Official Title:

The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia

Actual Study Start Date :

Nov 20, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cTBS stimulation The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.	Device: transcranial magnetic stimulation transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
Sham Comparator: Sham stimulation The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.	Device: sham stimulation TMS coil vertical to the brain surface, with same protocol as cTBS

Arm

Intervention/Treatment

Experimental: cTBS stimulation

The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

Device: transcranial magnetic stimulation

transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.

Sham Comparator: Sham stimulation

The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

Device: sham stimulation

TMS coil vertical to the brain surface, with same protocol as cTBS

Outcome Measures

Primary Outcome Measures

Three-Factor Eating Questionnaire [Change from Baseline to 6days and 36days]
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
MCCB [Change from Baseline to 6days and 36days]
The MATRICS™ Consensus Cognitive Battery
The positive and negative syndrome scale [Change from Baseline to 6days and 36days]
min score 30, max score 210. The higher score means more severe symptoms.
BMI [Change from Baseline to 6days and 36days]
body mass index

Secondary Outcome Measures

Resting EEG [Change from Baseline to 6days and 36days]
resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.
fasting glucose [Change from Baseline to 6days and 36days]
in mmol/l
Triglyceride [Change from Baseline to 6days and 36days]
in mmol/l
Total Cholesterol [Change from Baseline to 6days and 36days]
in mmol/l
Low Density Lipoprotein [Change from Baseline to 6days and 36days]
in mmol/l
High Density Lipoprotein [Change from Baseline to 6days and 36days]
in mmol/l

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with schizophrenia in accordance with DSM-5
The course of the disease less then 2 years
Accepting antipsychotics treatment for less 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

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

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renrong Wu, Professor, Central South University

ClinicalTrials.gov Identifier:

NCT05086133

Other Study ID Numbers:

WU2021TBS

First Posted:

Oct 20, 2021

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of May 4, 2022