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

NCT ID: NCT01940939

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2015-01-31

Brief Summary

1. Exploration of repetitive transcranial magnetic stimulation（rTMS）on working memory and cognitive impairment symptoms of schizophrenia treatment and mechanism.

2. Analysis of high-frequency repetitive transcranial magnetic stimulation stimulation to the improvement of negative symptoms and psychotic symptoms.

Detailed Description

The study was a randomized double-blind sham-controlled trial for 4 weeks. Patients with schizophrenia were treated with 20-Hz rTMS for 4 weeks to the left dorsolateral prefrontal cortex (added to the ongoing treatment). Negative symptoms were assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS).The auditory steady state responses (ASSR) were obtained for the assessment of gamma oscillation.And cognitive symptoms were assessed by MATRICS cognitive test battery (MCCB) Chinese version and n-back task.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active rTMS

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

Group Type: ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type: 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.

Sham rTMS

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

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type: 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.

Interventions

Repetitive Transcranial Magnetic Stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1）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

Exclusion Criteria

• 1)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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dengtang Liu, MD

Role: STUDY_DIRECTOR

Chief Psychiatrist and Professor

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31190822 (View on PubMed)

Other Identifiers

11ZR1431600

Identifier Type: -

Identifier Source: org_study_id