Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Schizoaffective Disorder, Treatment, Negative Symptoms, Positive Symptoms, TMS, rTMS
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.
Interventions
* individualized α frequency * left DLPFC 110% motor threshold (MT) * 13-15 sessions for 3 weeks
Sponsors
Niuvanniemi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Finland
Contacts
PRINCIPAL_INVESTIGATORHeli Tuppurainen, MD, PhD
Niuvanniemi Hospital
Outcome results
None listed