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NCT Number: NCT01941251

Navigated αTMS in Treatment-resistant Schizophrenia

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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Key information

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Niuvanniemi Hospital

Kuopio, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

navigated Transcranial Magnetic Stimulation

Device
  • individualized α frequency
  • left DLPFC 110% motor threshold (MT)
  • 13-15 sessions for 3 weeks

Other names: TMS, rTMS

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: at baseline,5 days after treatment, 3 months after treatment

    change in PANSS total, positive, negative and general psychopathology sum score

Secondary outcomes

  1. Clinical Global Impression - Improvement scale (CGI-I)

    Time frame: at 5 days after treatment, 3 months after treatment

    change in patient's illness relative to baseline state

  2. Neuropsychology test battery

    Time frame: at baseline, 5 days after treatment, 3 months after treatment

    Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.

Other outcomes

  1. plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF)

    Time frame: at baseline, 1 week after treatment

    change in P-/S-BDNF levels

Sponsors and collaborators

Lead sponsor

Niuvanniemi Hospital

Other

Registry information

Official study title

Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia

Acronym: nTMS_NS

Important dates

Study start
2013
Primary completion
2015
Study completion
2027
First posted
Sep 13, 2013
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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