Clinical trial NCT01941251: Navigated αTMS in Treatment-resistant Schizophrenia
Official title: Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
Schizophrenia
Schizoaffective Disorder
Treatment
Negative Symptoms
Positive Symptoms
TMS
rTMS
Lead sponsor: Niuvanniemi Hospital
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: at baseline,5 days after treatment, 3 months after treatment
Secondary outcomes:
measure: Clinical Global Impression - Improvement scale (CGI-I)
timeFrame: at 5 days after treatment, 3 months after treatment
measure: Neuropsychology test battery
timeFrame: at baseline, 5 days after treatment, 3 months after treatment
Other outcomes:
measure: plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF)
timeFrame: at baseline, 1 week after treatment
Locations:
city: Kuopio
country: Finland
facility: Niuvanniemi Hospital
Study officials:
affiliation: Niuvanniemi Hospital
name: Heli Tuppurainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: