iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

July 3, 2022 updated by: Renrong Wu, Central South University

iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Central South University
        • Contact:
        • Principal Investigator:
          • Renrong Wu, Prof
        • Sub-Investigator:
          • Qiongqiong Wu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for negative group

  • 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.
  • drug-naive Inclusion Criteria for positive group
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: healthy control
Experimental: predominant negative symptoms
iTBS for predominant negative symptoms
Device: Theta burst stimulation
a new paradigm of high frequency repetitive transcranial magnetic stimulation
No Intervention: positive symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET dopamine imaging and OGTT
Time Frame: immediate
PET dopamine imaging and OGTT after iTBS
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

July 3, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU2022PETTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Theta burst stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe