Navigated αTMS in Treatment-resistant Schizophrenia (nTMS_NS)

Niuvanniemi Hospital

Status

Active, not recruiting

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Device: navigated Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01941251

932012

Details and patient eligibility

About

Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia. However, previous studies have reported mixed or negative results. Majority of the repetitive transcranial magnetic stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS) integrates the individual MRI data, and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising results.

The aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.

Enrollment

50 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male righthanded inpatients, 18 to 64 years of age
The diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV
Capacity and willingness to give informed consent
Patient is treatment-resistant, CGI-S 4 or more
Patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment
No foreseeable changes in patient's smoking habits during treatment

Exclusion criteria

Serious somatic illness
Progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage
Unstable epilepsy
Electro convulsive therapy (ECT) less than 3 months prior to treatment