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Active, not recruitingNCT01941251nTMS_NSUpdated May 19, 2026

Navigated αTMS in Treatment-resistant Schizophrenia

An interventional study of navigated Transcranial Magnetic Stimulation and navigated Transcranial Magnetic Stimulation in Schizophrenia and Schizoaffective Disorder, sponsored by Niuvanniemi Hospital. Active, not recruiting at 1 site in Finland. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Niuvanniemi Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2013, registered Sep 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Male
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Study 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.

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Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder

Keywords

  • Transcranial Magnetic Stimulation
  • Repetitive Transcranial Magnetic Stimulation
  • Schizophrenia
  • Schizoaffective Disorder
  • Treatment
  • Negative Symptoms
  • Positive Symptoms
  • TMS
  • rTMS
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Niuvanniemi Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Male
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Navigated individualized αTMS

    navigated Transcranial Magnetic Stimulation

  • Sham comparator
    Sham TMS

    navigated Transcranial Magnetic Stimulation using sham coil

    Device: navigated Transcranial Magnetic Stimulation

Interventions

  • Devicenavigated Transcranial Magnetic Stimulation

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

    Also known as: TMS, rTMS

  • Devicenavigated Transcranial Magnetic Stimulation

    \- placebo treatment: sham coil

    Also known as: TMS, rTMS

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What researchers measure

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

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

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

Secondary outcomes

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

    change in patient's illness relative to baseline state

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

  2. Neuropsychology test battery

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

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

Other outcomes

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

    change in P-/S-BDNF levels

    Time frame: at baseline, 1 week after treatment

07

Study locations

1 site
  • Niuvanniemi Hospital
    Kuopio, Finland
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References and documents

Publications

  • 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. PubMed 38428970 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01941251
Lead sponsor
Niuvanniemi Hospital
Responsible party
Heli Tuppurainen (MD, PhD, Niuvanniemi Hospital) — Principal investigator
First posted
Sep 13, 2013
Start date
Mar 21, 2013
Primary completion
Dec 21, 2015
Completion
Dec 2027 (estimated)
Last update
May 19, 2026

Study contacts

Heli Tuppurainen, MD, PhD
principal investigator · Niuvanniemi Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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