Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Schizophrenia Patients With Auditory Hallucinations

NCT02863094 | Completed

• 1 other identifier: NSFC-81171273-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the treatment effect of continuous transcranial magnetic stimulation on schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by functional MRI

Conditions

Schizophrenia; Transcranial Magnetic Stimulation; Functional Magnetic Resonance Imaging

Keywords

schizophrenia; auditory hallucinations; functional magnetic resonance imaging; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Symptom improvement assessed by Auditory Hallucination Rating Scale

  up to 2 months

Secondary Outcomes (4)

• functional connectivity of the temporal parietal junction assessed by functional MRI

  up to 2 months

• Global network properties assessed through Graph Theory

  up to 2 months

• Symptom improvement assessed by Positive and Negative Syndrome Scale

  up to 2 months

• Global structural connectivity assessed by diffusion weighted image

  up to 2 months

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

The continuous theta burst stimulation (cTBS) protocol lasted 40 s and consisted of burst of 3 pulses delivered at 50 Hz, with bursts being repeated every 200 ms (at 5 Hz) for a total of 600 pulses. In the cTBS session, this 40s protocol was repeated for three times (1800 pulses in total) separated by two 15 min breaks (controlled by a stopwatch). MRI dataset should be acquired before the first cTBS session and after the last cTBS session.

Device: transcranial magnetic stimulation

Placebo Stimulation

SHAM COMPARATOR

The procedure of this protocol was performed by a placebo coil. Each session lasted 40 s and consisted of burst of 3 pulses delivered at 50 Hz, with bursts being repeated every 200 ms (at 5 Hz) for a total of 600 pulses. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first sham TBS session and after the last sham TBS session.

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

Placebo Stimulation; Real Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 reported auditory hallucinations at least 5 times per day based on pre-enrollment assessments using a written log or hand-held counter.
• 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 \> 7

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (1)

• Hua Q, Wang L, He K, Sun J, Xu W, Zhang L, Tian Y, Wang K, Ji GJ. Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations in Schizophrenia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444215. doi: 10.1001/jamanetworkopen.2024.44215.

  PMID: 39527055 DERIVED

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Kai Wang, MD

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: August 11, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)