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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01941251
Other study ID # 932012
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date December 2025

Study information

Verified date December 2023
Source Niuvanniemi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 2025
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Intervention

Device:
navigated Transcranial Magnetic Stimulation
individualized a frequency left DLPFC 110% motor threshold (MT) 13-15 sessions for 3 weeks
navigated Transcranial Magnetic Stimulation
- placebo treatment: sham coil

Locations

Country Name City State
Finland Niuvanniemi Hospital Kuopio

Sponsors (1)

Lead Sponsor Collaborator
Niuvanniemi Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF) change in P-/S-BDNF levels at baseline, 1 week after treatment
Primary 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
Secondary 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
Secondary Neuropsychology test battery Neuropsychology test battery consists of 6 tests for measuring neurocognitive function. at baseline, 5 days after treatment, 3 months after treatment
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