NCT03868358

Brief Summary

To investigate the treatment effect of intermittent theta-burst transcranial magnetic stimulation on symptomatic relief of schizophrenia patients, and the underlying neural mechanism by functional MRI and the resting electroencephalogram

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started May 2017

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

3.1 years

First QC Date

March 3, 2019

Last Update Submit

April 14, 2021

Conditions

SchizophreniaFunctional Magnetic Resonance ImagingTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Positive And Negative Syndrome Scale(PANSS)

    The improvment in PANSS scores will constitute the major research outcome measure used to assess response to rTMS,reflecting the symptom improvment in patients

    Baseline and 2 weeks post-treatment,and follow-up

Secondary Outcomes (7)

  • Scale for the Assessment of Positive Symptoms (SAPS)

    Baseline and 2 weeks post-treatment and follow-up

  • Scale for the Assessment of Negative Symptoms (SANS)

    Baseline and 2 weeks post-treatment and follow-up

  • Functional connectivity change of transcranial magnetic stimulation(iTBS and sham)

    Baseline and 2 weeks post-treatment

  • EEG change of transcranial magnetic stimulation(iTBS and sham)

    Baseline and 2 weeks post-treatment

  • Intertemporal decision test

    Baseline and 2 weeks post-treatment

  • +2 more secondary outcomes

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

Real Stimulation: active transcranial magnetic stimulation(Intermittent Theta Burst Stimulation).Participants will receive active TMS once daily for two weeks

Device: transcranial magnetic stimulation

Sham Stimulation

PLACEBO COMPARATOR

Sham Stimulation:no stimulation.Participants will receive sham TMS once daily for two weeks

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulationDEVICE

The stimulations were performed by MagStim Rapid2. Participants in active comparator will receive active transcranial magnetic stimulation(Real Stimulation) daily for two weeks. Participants in sham comparator will receive no stimulation(Sham Stimulation) daily for two weeks

Real StimulationSham Stimulation

Eligibility Criteria

Age18 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients met diagnostic criteria for schizophrenia or schizoaffective disorder using the Structural Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (SCID, Version 2.0).
  • Patients remain their psychotropic medication at steady dosages for at least 4 weeks prior to study entry and for the duration of the trial.
  • Verbal intelligence quotient \> 85 as measured by using a Chinese version of the National Adult Reading Test.

You may not qualify if:

  • History of significant head trauma or neurological disorders
  • Alcohol or drug abuse Focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery magnetic resonance images
  • a prior history of a seizure not induced by drug withdrawal,first degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease, such as thyroid disease, significant unstable medical condition, recent aggression or other forms of behavioral dyscontrol
  • left-handedness, pregnancy
  • estimated intelligence quotient\<80
  • current alcohol or drug abuse
  • inability to provide informed consent.
  • Hamilton Anxiety Rating Scale or the Hamilton Depression Rating Scale score \> 14

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab Anhui Medical University, PRC

Study Record Dates

First Submitted

March 3, 2019

First Posted

March 11, 2019

Study Start

May 21, 2017

Primary Completion

July 9, 2020

Study Completion

March 30, 2021

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

CN(1)