Navigated αTMS in Treatment-resistant Schizophrenia (nTMS_NS)

May 18, 2026 updated by: Heli Tuppurainen, Niuvanniemi Hospital

Navigated Alpha Frequency Transcranial Magnetic Stimulation (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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland
        • Niuvanniemi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Navigated individualized αTMS
navigated Transcranial Magnetic Stimulation
Device: navigated Transcranial Magnetic Stimulation
  • individualized α frequency
  • left DLPFC 110% motor threshold (MT)
  • 13-15 sessions for 3 weeks
Other Names:
  • TMS
  • rTMS
Device: navigated Transcranial Magnetic Stimulation
- placebo treatment: sham coil
Other Names:
  • TMS
  • rTMS
Sham Comparator: Sham TMS
navigated Transcranial Magnetic Stimulation using sham coil
Device: navigated Transcranial Magnetic Stimulation
  • individualized α frequency
  • left DLPFC 110% motor threshold (MT)
  • 13-15 sessions for 3 weeks
Other Names:
  • TMS
  • rTMS
Device: navigated Transcranial Magnetic Stimulation
- placebo treatment: sham coil
Other Names:
  • TMS
  • rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline,5 days after treatment, 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 5 days after treatment, 3 months after treatment
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.
at baseline, 5 days after treatment, 3 months after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline, 1 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niuvanniemi Hospital

Investigators

  • Principal Investigator: Heli Tuppurainen, MD, PhD, Niuvanniemi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2013

Primary Completion (Actual)

December 21, 2015

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimated)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 932012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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