nTMS_NS: Navigated αTMS in Treatment-resistant Schizophrenia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Navigated individualized αTMS navigated Transcranial Magnetic Stimulation |
Device: navigated Transcranial Magnetic Stimulation
individualized α frequency
left DLPFC 110% motor threshold (MT)
13-15 sessions for 3 weeks
Other Names:
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Sham Comparator: Sham TMS navigated Transcranial Magnetic Stimulation using sham coil |
Device: navigated Transcranial Magnetic Stimulation
- placebo treatment: sham coil
Other Names:
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Outcome Measures
Primary Outcome Measures
- Positive and Negative Syndrome Scale (PANSS) [at baseline,5 days after treatment, 3 months after treatment]
change in PANSS total, positive, negative and general psychopathology sum score
Secondary Outcome Measures
- Clinical Global Impression - Improvement scale (CGI-I) [at 5 days after treatment, 3 months after treatment]
change in patient's illness relative to baseline state
- Neuropsychology test battery [at baseline, 5 days after treatment, 3 months after treatment]
Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.
Other Outcome Measures
- plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF) [at baseline, 1 week after treatment]
change in P-/S-BDNF levels
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male righthanded inpatients, 18 to 64 years of age
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The diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV
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Capacity and willingness to give informed consent
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Patient is treatment-resistant, CGI-S 4 or more
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Patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment
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No foreseeable changes in patient's smoking habits during treatment
Exclusion Criteria:
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Serious somatic illness
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Progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage
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Unstable epilepsy
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Electro convulsive therapy (ECT) less than 3 months prior to treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Niuvanniemi Hospital | Kuopio | Finland |
Sponsors and Collaborators
- Niuvanniemi Hospital
Investigators
- Principal Investigator: Heli Tuppurainen, MD, PhD, Niuvanniemi Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 932012