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Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

Primary Purpose

Schizophrenia, Negative Symptoms in Schizophrenia, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bilateral Active Repetitive transcranial magnetic stimulation (rTMS)
Left Active Repetitive transcranial magnetic stimulation (rTMS)
Sham rTMS over bilateral dorsolateral prefrontal cortex
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Xuhui Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active rTMS over bilateral dorsolateral prefrontal cortex

Active rTMS over left dorsolateral prefrontal cortex

Sham rTMS over bilateral dorsolateral prefrontal cortex

Arm Description

Active rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.

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.

Sham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment
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.
Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment
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.

Secondary Outcome Measures

Mean Change From Baseline in Positive and Negative Syndrome Scale(PANSS)-Negative Symptoms Subscale Post Treatment
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.
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment
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.
Mean Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Post Treatment
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.

Full Information

First Posted
October 9, 2022
Last Updated
June 20, 2023
Sponsor
Shanghai Mental Health Center
Collaborators
Xuhui Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05599373
Brief Title
Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia
Official Title
Optimizing Treatment Protocol of High Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits and Negative Symptoms in Schizophrenia: an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Xuhui Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Negative Symptoms in Schizophrenia, Cognitive Impairment, Repetitive Transcranial Magnetic Stimulation, Dorsolateral Prefrontal Cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS over bilateral dorsolateral prefrontal cortex
Arm Type
Active Comparator
Arm Description
Active rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Arm Title
Active rTMS over left dorsolateral prefrontal cortex
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham rTMS over bilateral dorsolateral prefrontal cortex
Arm Type
Sham Comparator
Arm Description
Sham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Intervention Type
Device
Intervention Name(s)
Bilateral Active Repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Left Active Repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham rTMS over bilateral dorsolateral prefrontal cortex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment
Description
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.
Time Frame
Baseline and 4 weeks
Title
Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment
Description
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.
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Positive and Negative Syndrome Scale(PANSS)-Negative Symptoms Subscale Post Treatment
Description
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.
Time Frame
Baseline and 4 weeks
Title
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment
Description
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.
Time Frame
Baseline and 4 weeks
Title
Mean Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Post Treatment
Description
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.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhan, MD
Phone
18917757626
Email
jyzyan136@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suzhen Zhang, MD
Phone
18257209627
Email
zhangsuzhen_2013@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhan, MD
Organizational Affiliation
Shanghai Xuhui Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xuhui Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhan, MD
Phone
18917757626
Email
jyzyan136@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

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