Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

February 22, 2018 updated by: Shanghai Mental Health Center

A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.

This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dengtang Liu, MD
  • Phone Number: +86 21 64387250-73775
  • Email: erliu110@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The diagnosis of schizophrenia according to DSM-IV；
  • 18～55 years old；
  • schizophrenic illness duration longer than one year;
  • The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
  • Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
  • Able to adhere to the treatment schedule;
  • IQ≥80;
  • Dextromanual, normal vision and hearing;
  • Signed an informed consent

Exclusion Criteria:

  • rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
  • Acute risk of suicide and impulse；
  • patients to be diagnosed according to DSM-IV for substance abused, development delayed;
  • suffering from serious physical disease and can not accept the treatment;
  • history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
  • difficult to maintain the current drug treatment for at least 1 month;
  • undergoing ECT or MECT in last 3 months;
  • current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active rTMS
Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC).
Device: Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.
Sham Comparator: Sham rTMS
Sham stimulation will be delivered using the same stimulation parameters and at the same site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Device: Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale)
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS]
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in clinical global impression [CGI]
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0]
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Simpson-Angus Scale [SAS]
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS]
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in Letter-Number Span
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Wechsler Working Memory
Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment)
3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Change from baseline in Resting-state functional MRI:TR=2000 ms，TE=35 ms，FA=90，Matrix =64×64，Nex=1，FOV=256 mm，thickness=4 mm，Gap=0,scanning 33 slices。
Time Frame: 2 times (Before treatment,immediately after treatment)
2 times (Before treatment,immediately after treatment)
Change from baseline in diffusion tensor imaging (DTI):TR=8500,TE=87, matrix size=64×64, FOV=230, slices thickness = 3 mm, diff directions=30,scanning 46 slices
Time Frame: 2 times (Before treatment,immediately after treatment)
2 times (Before treatment,immediately after treatment)
Change from baseline in Magnetic Resonance Spectroscopy (MRS) of DMPFC
Time Frame: 2 times (Before treatment,immediately after treatment)
2 times (Before treatment,immediately after treatment)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rTMS-negative symptoms

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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