This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments navigated transcranial magnetic stimulation
Phase phase 2
Sponsor Niuvanniemi Hospital
Start date March 2013
End date December 2016
Trial size 50 participants
Trial identifier NCT01941251, 932012


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
navigated Transcranial Magnetic Stimulation
navigated transcranial magnetic stimulation TMS
individualized α frequency left DLPFC 110% motor threshold (MT) 13-15 sessions for 3 weeks
(Sham Comparator)
navigated Transcranial Magnetic Stimulation using sham coil
navigated transcranial magnetic stimulation TMS
- placebo treatment: sham coil

Primary Outcomes

Positive and Negative Syndrome Scale (PANSS)
time frame: at baseline,5 days after treatment, 3 months after treatment

Secondary Outcomes

Clinical Global Impression - Improvement scale (CGI-I)
time frame: at 5 days after treatment, 3 months after treatment
Neuropsychology test battery
time frame: at baseline, 5 days after treatment, 3 months after treatment

Eligibility Criteria

Male participants from 18 years up to 64 years old.

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

Additional Information

Official title Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia
Principal investigator Heli Tuppurainen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Niuvanniemi Hospital.