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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigated individualized αTMS | Active Comparator | navigated Transcranial Magnetic Stimulation | |
| Sham TMS | Sham Comparator | navigated Transcranial Magnetic Stimulation using sham coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| navigated Transcranial Magnetic Stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | change in PANSS total, positive, negative and general psychopathology sum score | at baseline,5 days after treatment, 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Improvement scale (CGI-I) | change in patient's illness relative to baseline state | at 5 days after treatment, 3 months after treatment |
| Neuropsychology test battery |
| Measure | Description | Time Frame |
|---|---|---|
| plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF) | change in P-/S-BDNF levels | at baseline, 1 week after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heli Tuppurainen, MD, PhD | Niuvanniemi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niuvanniemi Hospital | Kuopio | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38428970 | Derived | Tuppurainen H, Maatta S, Kononen M, Julkunen P, Kautiainen H, Hyvarinen S, Vaurio O, Joensuu M, Vanhanen M, Aho-Mustonen K, Mervaala E, Tiihonen J. Navigated and individual alpha-peak-frequency-guided transcranial magnetic stimulation in male patients with treatment-refractory schizophrenia. J Psychiatry Neurosci. 2024 Mar 1;49(2):E87-E95. doi: 10.1503/jpn.230063. Print 2024 Jan-Feb. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| navigated Transcranial Magnetic Stimulation | Device | - placebo treatment: sham coil |
|
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Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.
| at baseline, 5 days after treatment, 3 months after treatment |