SchizophrenianTMS_NSNCT01941251
Navigated αTMS in Treatment-resistant Schizophrenia
A study testing navigated Transcranial Magnetic Stimulation in people with Schizophrenia and Schizoaffective Disorder, run by Niuvanniemi Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- navigated Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 21 Mar 2013to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- navigated Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Schizoaffective Disorder, Treatment, Negative Symptoms, Positive Symptoms, TMS, rTMS
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated Transcranial Magnetic StimulationDevice
Also called TMS, rTMS
- individualized α frequency
- left DLPFC 110% motor threshold (MT)
- 13-15 sessions for 3 weeks
navigated Transcranial Magnetic StimulationDevice
Also called TMS, rTMS
- placebo treatment: sham coil
| Study group | Role | What they receive |
|---|---|---|
| Navigated individualized αTMS | Active comparator | navigated Transcranial Magnetic Stimulation |
| Sham TMS | Sham comparator | navigated Transcranial Magnetic Stimulation using sham coil Receives: Device: navigated Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
change in PANSS total, positive, negative and general psychopathology sum score
Measured: at baseline,5 days after treatment, 3 months after treatment
Secondary outcomes (2)
Clinical Global Impression - Improvement scale (CGI-I)
change in patient's illness relative to baseline state
Measured: at 5 days after treatment, 3 months after treatment
Neuropsychology test battery
Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.
Measured: at baseline, 5 days after treatment, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start21 Mar 2013
- Primary completion21 Dec 2015
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niuvanniemi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heli Tuppurainen, Niuvanniemi Hospital
- Investigators
- Heli Tuppurainen, MD, PhD, Principal investigator, Niuvanniemi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941251
- Sponsor's protocol ID
- 932012
- Acronym
- nTMS_NS
- Status last verified
- May 2026
- First submitted
- 9 Sep 2013
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT01941251
- Acronym / sponsor ID
- nTMS_NS / 932012
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Schizoaffective Disorder, Treatment, Negative Symptoms, Positive Symptoms, TMS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Niuvanniemi HospitalUniversity, hospital or other
- Study start
- 21 Mar 2013 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigated individualized αTMS | Active comparator | –navigated Transcranial Magnetic Stimulation |
| Sham TMS | Sham comparator | Device: navigated Transcranial Magnetic Stimulationnavigated Transcranial Magnetic Stimulation using sham coil |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigated Transcranial Magnetic StimulationAlso: TMS, rTMS* individualized α frequency * left DLPFC 110% motor threshold (MT) * 13-15 sessions for 3 weeks | Device | – |
| navigated Transcranial Magnetic StimulationAlso: TMS, rTMS- placebo treatment: sham coil | Device | Sham TMS |
Primary outcome
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
2 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 38428970Tuppurainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heli Tuppurainen, MD, PhD principal investigator
Niuvanniemi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated Transcranial Magnetic Stimulation in people with Schizophrenia and Schizoaffective Disorder, run by Niuvanniemi Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: at baseline,5 days after treatment, 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.