Back to resultsrTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
Primary Purpose
Schizophrenia and Related Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia and Related Disorders focused on measuring Schizophrenia, repetitive transcranial magnetic stimulation
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 years Able to give informed consent Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5 Has a score ≥ 7 on Calgary depression scale for schizophrenia The principal psychotropic agents are not changed within one month of the first session of rTMS Exclusion Criteria: DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE < 15) With electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator [ICD], cerebral shunts, cochlear implant, etc.) With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.) Pregnant, or has a pregnancy plan within 3 months With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion Received rTMS or iTBS treatment within 3 months Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
Sites / Locations
- Department of Psychiatry, National Taiwan University Hospital Yunlin BranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Sham Comparator
Arm Label
conventional rTMS
iTBS
sham rTMS
sham iTBS
Arm Description
target: left DLPFC protocol: 10Hz for 4 seconds, 120% motor threshold, 75 trains with 26-second interval, 3000 pulses per session, one session per day, five sessions per week, two weeks in total
target: left DLPFC protocol: 3 pulses at 50Hz, 90% motor threshold, repeated at 5Hz, 60 trains of 10 bursts with 8-second intervals, 1800 pulses per session, one session per day, five sessions per week, two weeks in total
target: left DLPFC sham probe, the same protocol as active conventional rTMS
target: left DLPFC sham probe, the same protocol as active iTBS
Outcomes
Primary Outcome Measures
Change from Baseline in Calgary Depression Scale for Schizophrenia
A 9-item scale developed for detecting major depressive episode for schizophrenia patients. Total score ranges from 0 to 27. Lower score indicates less depressive symptoms. A cut-off of 7 points yields to sensitivity of 85% and specificity of 82%.
Secondary Outcome Measures
Change from Baseline in Positive and Negative syndrome scale
A 30-item scale developed to evaluating positive, negative and general symptoms for schizophrenia patients. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms.
Change from Baseline in Negative symptoms assessment 16
A scale developed to evaluating negative symptoms for schizophrenia patients. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 domain scores are the sum of item scores in each domain i.e. communication (min score 4, max score 24), emotion/affect (min 3, max 18), social involvement (min 3, max 18), motivation (min 4, max 24), and retardation (min 2, max 12); with higher scores denoting more severe negative symptoms in schizophrenia.
Change from Baseline in Clinical global impression
A scale for primary-care psychiatrist to evaluate global symptom severity of a patient in comparison with others with same diagnosis. Lower score indicates less severe illness.
Change from Baseline in Self-Reported Graphic version of the Personal and Social Performance Scale
A 22-item self-rated scale for schizophrenia patients, which includes four domains, i.e., global function (6 items, total scores 6-18), personal and social performance (5 items, total scores 5-15), self-care (6 items, total scores 6-18) and disturbing behaviors (5 items, total scores 5-15). Lower score indicates less severe illness.
Full Information
NCT ID
NCT05671185
First Posted
December 18, 2022
Last Updated
January 2, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05671185
Brief Title
rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
Official Title
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
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
Around 40% of schizophrenia patients present depressive symptoms, which are associated with elevated suicide and violence risk and poor prognosis and quality of life. Recent meta-analysis showed the effect size of antidepressants for depressive symptoms of schizophrenia patients was as low as 0.25, so new therapeutic approach is warranted.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, anesthesia-free brain stimulation therapy for treatment refractory depression. Currently, rTMS is classified as high-frequency stimulation (>5Hz, usually 10Hz or 20Hz) and low-frequency inhibition (usually 1Hz). Intermittent theta burst stimulation (iTBS) is a new variant of rTMS, with stimulation frequency as high as 50Hz. Compared with high-frequency rTMS, iTBS has similar therapeutic effect and shorter stimulation duration. Up to now, studies exploring treatment effect of rTMS or iTBS for schizophrenia patients mainly focused on negative symptoms rather than depressive symptoms. Therefore, this study aims to explore treatment effect of rTMS or iTBS of depressive symptoms, negative symptoms, cognitive function and physiological indices for schizophrenia patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Related Disorders
Keywords
Schizophrenia, repetitive transcranial magnetic stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional rTMS
Arm Type
Experimental
Arm Description
target: left DLPFC
protocol: 10Hz for 4 seconds, 120% motor threshold, 75 trains with 26-second interval, 3000 pulses per session, one session per day, five sessions per week, two weeks in total
Arm Title
iTBS
Arm Type
Experimental
Arm Description
target: left DLPFC
protocol: 3 pulses at 50Hz, 90% motor threshold, repeated at 5Hz, 60 trains of 10 bursts with 8-second intervals, 1800 pulses per session, one session per day, five sessions per week, two weeks in total
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
target: left DLPFC
sham probe, the same protocol as active conventional rTMS
Arm Title
sham iTBS
Arm Type
Sham Comparator
Arm Description
target: left DLPFC
sham probe, the same protocol as active iTBS
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
Primary Outcome Measure Information:
Title
Change from Baseline in Calgary Depression Scale for Schizophrenia
Description
A 9-item scale developed for detecting major depressive episode for schizophrenia patients. Total score ranges from 0 to 27. Lower score indicates less depressive symptoms. A cut-off of 7 points yields to sensitivity of 85% and specificity of 82%.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Secondary Outcome Measure Information:
Title
Change from Baseline in Positive and Negative syndrome scale
Description
A 30-item scale developed to evaluating positive, negative and general symptoms for schizophrenia patients. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Title
Change from Baseline in Negative symptoms assessment 16
Description
A scale developed to evaluating negative symptoms for schizophrenia patients. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 domain scores are the sum of item scores in each domain i.e. communication (min score 4, max score 24), emotion/affect (min 3, max 18), social involvement (min 3, max 18), motivation (min 4, max 24), and retardation (min 2, max 12); with higher scores denoting more severe negative symptoms in schizophrenia.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Title
Change from Baseline in Clinical global impression
Description
A scale for primary-care psychiatrist to evaluate global symptom severity of a patient in comparison with others with same diagnosis. Lower score indicates less severe illness.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Title
Change from Baseline in Self-Reported Graphic version of the Personal and Social Performance Scale
Description
A 22-item self-rated scale for schizophrenia patients, which includes four domains, i.e., global function (6 items, total scores 6-18), personal and social performance (5 items, total scores 5-15), self-care (6 items, total scores 6-18) and disturbing behaviors (5 items, total scores 5-15). Lower score indicates less severe illness.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Physiological Parameters - Heart Rate Variability
Description
Measurement of parasympathetic activity.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Title
Change from Baseline in Physiological Parameters - Skin Conductance
Description
Measurement of sympathetic activity.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Title
Change from Baseline in Physiological Parameters - Body Temperature
Description
Measurement of autonomic nervous system.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Title
Change from Baseline in Physiological Parameters - Respiratory Rate
Description
Measurement of autonomic nervous system.
Time Frame
baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 20 years
Able to give informed consent
Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5
Has a score ≥ 7 on Calgary depression scale for schizophrenia
The principal psychotropic agents are not changed within one month of the first session of rTMS
Exclusion Criteria:
DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months
Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE < 15)
With electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator [ICD], cerebral shunts, cochlear implant, etc.)
With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.)
Pregnant, or has a pregnancy plan within 3 months
With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion
Received rTMS or iTBS treatment within 3 months
Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hao Ma, MD
Phone
+886-5-5323911
Ext
7107
Email
chiahaoma.tw@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hao Ma, MD
Organizational Affiliation
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
City
Douliu, Yunlin
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Hao Ma, MD
Phone
+886-5-532-3911
Ext
7107
Email
chiahaoma.tw@gmail.com
First Name & Middle Initial & Last Name & Degree
Chia-Hao Ma, MD
12. IPD Sharing Statement
Learn more about this trial
rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
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