Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

June 20, 2023 updated by: Shanghai Mental Health Center

Optimizing Treatment Protocol of High Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits and Negative Symptoms in Schizophrenia: an Exploratory Study

Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be a randomized, double-blind trial comparing active rTMS over bilateral DLPFC vs. active rTMS over left DLPFC vs. sham rTMS delivered over DLPFC an 4-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 20 sessions of either active rTMS over left DLPFC or bilateral DLPFC or placebo treatments.

Study Type

Interventional

Enrollment (Estimated)

90

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 Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 20030
        • Recruiting
        • Shanghai Xuhui Mental Health Center
        • Contact:

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Met the Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V) diagnostic criteria for schizophrenia and the diagnosis was verified by an experienced psychiatrist based on the Mini-International Neuropsychiatric Interview (MINI) 7.0 .
  • Age between 18 and 60.
  • Patients with prominently negative symptoms, which was defined as: PANSS negative subscore≥15 points and one of items N1-N7 scoring≥4.
  • All patients were in stable clinical conditions (reduction rate of PANSS score<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent.

Exclusion Criteria:

  • Any contraindication for rTMS (e.g., intracranial metal, pacemakers, cochlear and intracranial hypertension).
  • Unstable clinical condition (e.g., being aggressive and uncooperative).
  • Current substance abuse.
  • Any other psychiatric diagnosis.
  • Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases.
  • Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active rTMS over bilateral dorsolateral prefrontal cortex
Active rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Device: Bilateral Active Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over bilateral dorsolateral prefrontal cortex (DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of each side resting motor threshold (MT). The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Active Comparator: Active rTMS over left dorsolateral prefrontal cortex
Active rTMS over left dorsolateral prefrontal cortex and sham rTMS over right dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Device: Left Active Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex(DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of left resting motor threshold (MT). Sham rTMS stimulation was delivered over right dorsolateral prefrontal cortex(DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Sham Comparator: Sham rTMS over bilateral dorsolateral prefrontal cortex
Sham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Device: Sham rTMS over bilateral dorsolateral prefrontal cortex
Sham rTMS stimulation was delivered over bilateral dorsolateral prefrontal cortex (DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment
Time Frame: Baseline and 4 weeks
The Assessment of Negative Symptoms(SANS) is a standardized assessment utilizing a 6-point scale with which the clinician rates the degree to which the severity of the subject's negative symptoms. It consists of 19 items assessing five symptoms of the negative dimension: Affect flattening, alogia, avolition-apathy, anhedonia-asociality, and poor attention.
Baseline and 4 weeks
Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment
Time Frame: Baseline and 4 weeks
The MATRICS Consensus Cognitive Batteryis a standardized rating tool to assess the severity of the subject's cognitive symptoms, which consisted of seven domains and the total score: speed of processing, attention/vigilance, working memory, visual learning, verbal learning, reasoning/problem solving, and social cognition.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Positive and Negative Syndrome Scale(PANSS)-Negative Symptoms Subscale Post Treatment
Time Frame: Baseline and 4 weeks
The Positive and Negative Syndrome Scale(PANSS)-Negative Subscale is a valid assessment utilizing a 7 items, 7-point scale with which the clinician rates the degree to which the severity of the subject's negative symptoms.
Baseline and 4 weeks
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment
Time Frame: Baseline and 4 weeks
The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a single item, 7-point scale with which the clinician rates the severity of the subject's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.
Baseline and 4 weeks
Mean Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Post Treatment
Time Frame: Baseline and 4 weeks
Calgary Depression Scale for Schizophrenia (CDSS) is a nine item structures interview scale, in which each item has a four point measure, which has been specifically developed to assess depression in schizophrenics.
Baseline and 4 weeks

Collaborators and Investigators

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

Sponsor

Shanghai Mental Health Center

Collaborators

Xuhui Mental Health Center

Investigators

  • Principal Investigator: Yan Zhan, MD, Shanghai Xuhui Mental Health Center

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 (Actual)

January 1, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

October 9, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHJW2020KY003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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