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Completed

NCT Number: NCT03273439

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Right-handed;
  • meeting the diagnosis of schizophrenia for at least 2 years;
  • had been on anti-psychotic medications for more than 12 weeks;
  • with unresolved negative symptoms (SANS>20).

Exclusion criteria

  • with substance use disorders ;
  • with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;
  • receiving electroconvulsive therapy in the past 3 months.

Treatment and study plan

Repetitive TMS

Device

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).

Other names: rTMS

sham rTMS

Device

Sham rTMS, without stimulation

Primary outcomes

  1. Scale for the Assessment of Negative Symptoms (SANS)

    Time frame: 4 weeks

    clinical negative symptoms

Secondary outcomes

  1. Positive and Negative symptom scale (PANSS)

    Time frame: 4 weeks

    Clinical symptoms

  2. CANTAB

    Time frame: 4 weeks

    cognition

Sponsors and collaborators

Lead sponsor

Suzhou Psychiatric Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 6, 2017
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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