NCT03273439

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

March 15, 2017

Last Update Submit

September 5, 2017

Conditions

Schizophrenia

Keywords

Repetitive transcranial magnetic stimulationNegative symptomsrandomized controlled trialSchizophreniacognition

Outcome Measures

Primary Outcomes (1)

  • Scale for the Assessment of Negative Symptoms (SANS)

    clinical negative symptoms

    4 weeks

Secondary Outcomes (2)

  • Positive and Negative symptom scale (PANSS)

    4 weeks

  • CANTAB

    4 weeks

Study Arms (2)

repetitive TMS

EXPERIMENTAL

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).

Device: repetitive TMS

Sham rTMS

SHAM COMPARATOR

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.

Device: Sham rTMS

Interventions

repetitive TMSDEVICE

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).

Also known as: rTMS
repetitive TMS
Sham rTMSDEVICE

Sham rTMS, without stimulation

Sham rTMS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li J, Lu X, Du S, Hu W, Xiao D, He B, Su C, Lin S, Zhan Q, Wu H, Li Z. Effects of varied rTMS frequencies on cognitive function in individuals with chronic schizophrenia: A double-blind randomized controlled trial. J Psychiatr Res. 2025 Sep;189:33-41. doi: 10.1016/j.jpsychires.2025.05.052. Epub 2025 May 23.

    PMID: 40479952DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Guangzhong Yin, MD

    Suzhou Guangji Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Psychiatrist

Study Record Dates

First Submitted

March 15, 2017

First Posted

September 6, 2017

Study Start

July 1, 2012

Primary Completion

February 1, 2014

Study Completion

June 30, 2015

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share