NCT03774927

Brief Summary

A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for cognitive impairments in 120 chronic schizophrenia patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

December 11, 2018

Last Update Submit

April 28, 2019

Conditions

Schizophrenia

Keywords

schizophreniarTMS

Outcome Measures

Primary Outcomes (2)

  • Repeatable Battery for the Assessment of Neuropsychological Status for cognition

    cognitive performance

    8 weeks

  • Positive and Negative Syndrome Scale for clinical symptoms

    clinical symptoms

    8 weeks

Secondary Outcomes (1)

  • Treatment Emergent Symptoms Scale for side effects

    8 weeks

Study Arms (3)

10 Hz treatment group

EXPERIMENTAL

In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.

Device: 10 Hz treatment group

20 Hz treatment group

EXPERIMENTAL

In active rTMS, 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.

Device: 20 Hz treatment group

Control Group

SHAM COMPARATOR

In sham rTMS, all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.

Device: Control Group

Interventions

10 Hz treatment groupDEVICE

10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.

10 Hz treatment group
20 Hz treatment groupDEVICE

20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.

20 Hz treatment group
Control GroupDEVICE

all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizopherenia by two senior psychiatrists
  • Male
  • Right-handed
  • Between 18 and 60 years and Han Chinese
  • Duration of symptoms at least 60 months
  • Received stable doses of antipsychotic drugs at least 12 months
  • With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS \< 24)

You may not qualify if:

  • A DSM-IV Axis I diagnosis other than schizophrenia
  • Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
  • Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
  • Severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
  • Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
  • Education level less than 5 years by subject report,
  • Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
  • Subjects who suffered from alcohol or illegal drug abuse/dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Dlabac-de Lange JJ, Liemburg EJ, Bais L, Renken RJ, Knegtering H, Aleman A. Effect of rTMS on brain activation in schizophrenia with negative symptoms: A proof-of-principle study. Schizophr Res. 2015 Oct;168(1-2):475-82. doi: 10.1016/j.schres.2015.06.018. Epub 2015 Jul 14.

    PMID: 26187147BACKGROUND

  • Mogg A, Purvis R, Eranti S, Contell F, Taylor JP, Nicholson T, Brown RG, McLoughlin DM. Repetitive transcranial magnetic stimulation for negative symptoms of schizophrenia: a randomized controlled pilot study. Schizophr Res. 2007 Jul;93(1-3):221-8. doi: 10.1016/j.schres.2007.03.016. Epub 2007 May 2.

    PMID: 17478080RESULT

  • Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.

    PMID: 25582269RESULT

  • Zhu C, Yao J, Guan H, Wu F, Xiu M. Moderating role of familial relationships in the efficacy of rTMS intervention on cognitive function in patients with schizophrenia. BMC Psychiatry. 2025 Oct 21;25(1):1010. doi: 10.1186/s12888-025-07251-y.

    PMID: 41121094DERIVED

  • Su X, Zhao L, Shang Y, Chen Y, Liu X, Wang X, Xiu M, Yu H, Liu L. Repetitive transcranial magnetic stimulation for psychiatric symptoms in long-term hospitalized veterans with schizophrenia: A randomized double-blind controlled trial. Front Psychiatry. 2022 Sep 23;13:873057. doi: 10.3389/fpsyt.2022.873057. eCollection 2022.

    PMID: 36213928DERIVED

  • Xiu MH, Guan HY, Zhao JM, Wang KQ, Pan YF, Su XR, Wang YH, Guo JM, Jiang L, Liu HY, Sun SG, Wu HR, Geng HS, Liu XW, Yu HJ, Wei BC, Li XP, Trinh T, Tan SP, Zhang XY. Cognitive Enhancing Effect of High-Frequency Neuronavigated rTMS in Chronic Schizophrenia Patients With Predominant Negative Symptoms: A Double-Blind Controlled 32-Week Follow-up Study. Schizophr Bull. 2020 Sep 21;46(5):1219-1230. doi: 10.1093/schbul/sbaa035.

    PMID: 32185388DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hengyong Guan, Doctor

    Hebei Province Veteran Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

January 1, 2017

Primary Completion

October 30, 2018

Study Completion

November 30, 2018

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Data with be available on request