Study of Repetitive Transcranial Magnetic Stimulation in the Treatment of Cognitive Impairment in Schizophrenia

NCT01940939 | Completed Results DMC

• 1 other identifier: 11ZR1431600
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Exploration of repetitive transcranial magnetic stimulation（rTMS）on working memory and cognitive impairment symptoms of schizophrenia treatment and mechanism.
2. 2.Analysis of high-frequency repetitive transcranial magnetic stimulation stimulation to the improvement of negative symptoms and psychotic symptoms.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• The Change in the Severity of Negative Symptoms

  The assessment of negative symptoms were measured with the Positive and Negative Symptom Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS).The SANS contains 30 particular items divided into 5 symptomatological domains: 1) affective flattening and/or blunting, 2) alogia, 3) avolition and/or apathy, 4) anhedonia, and 5) impaired attention. Each item is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 150. Higher scores indicate more impairment.The PANSS contains 30 particular items divided into 3 subscores: 1)positive, 2) negative, and 3) general subscore. Each item is scored on a scale from 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. The primary outcomes were the changes in the severity of negative symptoms as measured with SANS total score and PANSS negative subscore after 4 weeks of intervention.

  Baseline, after 4 weeks of treatment

Secondary Outcomes (1)

• MATRICS Consensus Cognitive Battery (MCCB) in Chinese Version

  Baseline and 4 weeks

Other Outcomes (1)

• Event-related Spectral Perturbation (ERSP)

  4 weeks

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.Intervention: Device: Repetitive Transcranial Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ）patients to be diagnosed according to the Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV) for paranoid schizophrenia；2）20～49 years old；3）Duration of 2 \~ 10 years;4）the disease situation is stable， the fluctuation of Positive and Negative Symptom Scale（PANSS）total score ≤10% in last 1 month, and have accepted the current drugs for more than 8 weeks; 5）Patients, their families and doctors are agreed that the disease situation is stable and maintained current drug treatment in next month；6）Signed an informed consent

You may not qualify if:

• )patients to be diagnosed according to DSM-IV for substance abused,development delayed;2)suffering from serious physical disease and can not accept the treatment;3)repetitive transcranial magnetic stimulation(rTMS) contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;4)the disease situation is not stable， the fluctuation of Positive and Negative Symptom Scale（PANSS）total score \>10% in last 1 month, Positive and Negative Symptom Scale（PANSS）total score \> 60;5)difficult to maintain the current drug treatment for at least 1 month;6）undergoing electroconvulsive therapy（ECT）in last 3 months.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Zhuo K, Tang Y, Song Z, Wang Y, Wang J, Qian Z, Li H, Xiang Q, Chen T, Yang Z, Xu Y, Fan X, Wang J, Liu D. Repetitive transcranial magnetic stimulation as an adjunctive treatment for negative symptoms and cognitive impairment in patients with schizophrenia: a randomized, double-blind, sham-controlled trial. Neuropsychiatr Dis Treat. 2019 May 8;15:1141-1150. doi: 10.2147/NDT.S196086. eCollection 2019.

  PMID: 31190822 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: ShanghaiMHC
• Organization: Dr.LIU

erliu110@126.com

862134773775

Study Officials

• Dengtang Liu, MD

  Chief Psychiatrist and Professor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: February 1, 2013
• Primary Completion: December 31, 2014
• Study Completion: January 31, 2015
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2014-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)