rTMS on Appetite and Cognitive Function in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

iTBS

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

Shame stimulation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Shame stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No