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A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive TMS
Sham rTMS
Sponsored by
Suzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Repetitive transcranial magnetic stimulation, Negative symptoms, randomized controlled trial, Schizophrenia, cognition

Eligibility Criteria

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

Inclusion Criteria:

  1. Right-handed;
  2. meeting the diagnosis of schizophrenia for at least 2 years;
  3. had been on anti-psychotic medications for more than 12 weeks;
  4. with unresolved negative symptoms (SANS>20).

Exclusion Criteria:

  1. with substance use disorders ;
  2. with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;
  3. receiving electroconvulsive therapy in the past 3 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    repetitive TMS

    Sham rTMS

    Arm Description

    Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).

    all procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS.

    Outcomes

    Primary Outcome Measures

    Scale for the Assessment of Negative Symptoms (SANS)
    clinical negative symptoms

    Secondary Outcome Measures

    Positive and Negative symptom scale (PANSS)
    Clinical symptoms
    CANTAB
    cognition

    Full Information

    First Posted
    March 15, 2017
    Last Updated
    September 5, 2017
    Sponsor
    Suzhou Psychiatric Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03273439
    Brief Title
    A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia
    Official Title
    A Randomized, Double-blind Study of Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits in Chronic Patients With Schizophrenia in a Chinese Han Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2012 (Actual)
    Primary Completion Date
    February 1, 2014 (Actual)
    Study Completion Date
    June 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Suzhou Psychiatric Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
    Detailed Description
    This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Repetitive transcranial magnetic stimulation, Negative symptoms, randomized controlled trial, Schizophrenia, cognition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
    Masking
    Participant
    Masking Description
    This was a single-institution, randomized controlled, double blinded trial. Participants were randomized to receive, over 4 weeks, 20 sessions of either active or sham rTMS. Clinical assessment was performed at baseline, 4 weeks and 8 weeks by 2 psychiatrists blinded to the treatment assigned. Inter-rater reliability was satisfactory (κa=0.86).
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    repetitive TMS
    Arm Type
    Experimental
    Arm Description
    Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
    Arm Title
    Sham rTMS
    Arm Type
    Sham Comparator
    Arm Description
    all procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS.
    Intervention Type
    Device
    Intervention Name(s)
    repetitive TMS
    Other Intervention Name(s)
    rTMS
    Intervention Description
    Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
    Intervention Type
    Device
    Intervention Name(s)
    Sham rTMS
    Intervention Description
    Sham rTMS, without stimulation
    Primary Outcome Measure Information:
    Title
    Scale for the Assessment of Negative Symptoms (SANS)
    Description
    clinical negative symptoms
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Positive and Negative symptom scale (PANSS)
    Description
    Clinical symptoms
    Time Frame
    4 weeks
    Title
    CANTAB
    Description
    cognition
    Time Frame
    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: Right-handed; meeting the diagnosis of schizophrenia for at least 2 years; had been on anti-psychotic medications for more than 12 weeks; with unresolved negative symptoms (SANS>20). Exclusion Criteria: with substance use disorders ; with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases; receiving electroconvulsive therapy in the past 3 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guangzhong Yin, MD
    Organizational Affiliation
    Suzhou Guangji Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia

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