A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-blind Study of Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits in Chronic Patients With Schizophrenia in a Chinese Han Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273439
• Other study ID #: 46694276-1
• Secondary ID: Szzx201509
• Status: Completed
• Phase: N/A
• First received: March 15, 2017
• Last updated: September 5, 2017
• Start date: July 1, 2012
• Est. completion date: June 30, 2015

Study information

• Verified date: September 2017
• Source: Suzhou Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.

Description:

This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 30, 2015
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Right-handed;

2. meeting the diagnosis of schizophrenia for at least 2 years;

3. had been on anti-psychotic medications for more than 12 weeks;

4. with unresolved negative symptoms (SANS>20).

Exclusion Criteria:

1. with substance use disorders ;

2. with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;

3. receiving electroconvulsive therapy in the past 3 months.

Related Conditions & MeSH terms

• Cognition Disorders
• Schizophrenia

Intervention

Device:
• repetitive TMS
Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
• Sham rTMS
Sham rTMS, without stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Psychiatric Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale for the Assessment of Negative Symptoms (SANS)	clinical negative symptoms	4 weeks
Secondary	Positive and Negative symptom scale (PANSS)	Clinical symptoms	4 weeks
Secondary	CANTAB	cognition	4 weeks