Back to results

Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

Primary Purpose

Schizophrenia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, rTMS

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The diagnosis of schizophrenia according to DSM-IV；
18～55 years old；
schizophrenic illness duration longer than one year;
The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
Able to adhere to the treatment schedule;
IQ≥80;
Dextromanual, normal vision and hearing;
Signed an informed consent

Exclusion Criteria:

rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
Acute risk of suicide and impulse；
patients to be diagnosed according to DSM-IV for substance abused, development delayed;
suffering from serious physical disease and can not accept the treatment;
history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
difficult to maintain the current drug treatment for at least 1 month;
undergoing ECT or MECT in last 3 months;
current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC).

Sham stimulation will be delivered using the same stimulation parameters and at the same 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.

Outcomes

Primary Outcome Measures

Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale)

Secondary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale

Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS]

Change from baseline in clinical global impression [CGI]

Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0]

Change from baseline in Simpson-Angus Scale [SAS]

Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS]

Full Information

NCT ID

NCT02842034

First Posted

June 20, 2016

Last Updated

February 22, 2018

Sponsor

Shanghai Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT02842034

Brief Title

Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

Official Title

A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

Detailed Description

The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia, rTMS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS

Arm Type

Active Comparator

Arm Description

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation

Intervention Description

Stimulate the dorsomedial prefrontal cortex for 4 weeks.

Primary Outcome Measure Information:

Title

Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale)

Time Frame