iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

NCT ID: NCT05448430

Last Updated: 2022-07-07

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-07-01

Brief Summary

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Aim: 1. To confirm that patients with predominant negative symptoms in schizophrenia have deficits in frontal cortical dopamine release when compared with healthy control and patients with positive symptoms.

2\. Our previous study found patients with negative symptoms have more possibilities to have disorders in glucose metabolism, we wonder whether dopamine release, negative symptoms or glucose metabolism can be improved by iTBS.

Study design: Case control study.

Detailed Description

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Eligibility Criteria: Predominant negative symptoms for Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or more, and score of 4 or more on at least two of three core negative PANSS items, PANSS for positive symptoms of 19 or less, HAMD depression scale of 16 or less. Predominant positive symptoms for PANSS for positive symptoms of 20 or more. Healthy control will be recruited matching the age and sex of patient groups, Outcome Measures: Oral glucose tolerance test (OGTT), PET dopamine imaging.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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predominant negative symptoms

iTBS for predominant negative symptoms

Group Type EXPERIMENTAL

Theta burst stimulation

Intervention Type DEVICE

a new paradigm of high frequency repetitive transcranial magnetic stimulation

positive symptoms

Group Type NO_INTERVENTION

No interventions assigned to this group

healthy control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Theta burst stimulation

a new paradigm of high frequency repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosed with schizophrenia according to ICD-10 or DSM-V
* Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or moreand score of 4 or more on at least two of three core negative PANSS items
* PANSS for positive symptoms of 19 or less, and HAMD depression scale of 16 or less.
* PANSS for positive symptoms of 20 or more
* drug-naive

Exclusion Criteria

* drug or alcohol addiction
* diagnosed with other major mental disorders according to ICD-10 or DSM-V
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Renrong Wu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Central Contacts

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Qiongqiong Wu, MD

Role: CONTACT

8615084781635

Facility Contacts

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Renrong Wu, Prof

Role: primary

+86 158 741 79855

Other Identifiers

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WU2022PETTMS

Identifier Type: -

Identifier Source: org_study_id

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