Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2013-03-31
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Navigated individualized αTMS
navigated Transcranial Magnetic Stimulation
navigated Transcranial Magnetic Stimulation
* individualized α frequency
* left DLPFC 110% motor threshold (MT)
* 13-15 sessions for 3 weeks
Sham TMS
navigated Transcranial Magnetic Stimulation using sham coil
navigated Transcranial Magnetic Stimulation
\- placebo treatment: sham coil
Interventions
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navigated Transcranial Magnetic Stimulation
* individualized α frequency
* left DLPFC 110% motor threshold (MT)
* 13-15 sessions for 3 weeks
navigated Transcranial Magnetic Stimulation
\- placebo treatment: sham coil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
MALE
No
Sponsors
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Niuvanniemi Hospital
OTHER
Responsible Party
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Heli Tuppurainen
MD, PhD
Principal Investigators
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Heli Tuppurainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Niuvanniemi Hospital
Locations
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Niuvanniemi Hospital
Kuopio, , Finland
Countries
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References
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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.
Other Identifiers
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932012
Identifier Type: -
Identifier Source: org_study_id