SchizophreniaNCT02127879
Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia
A study testing Transcranial Magnetic Stimulation in people with Schizophrenia, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The main purpose of this study is to determine whether intensive repetitive transcranial magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in schizophrenia patients and whether it has a positive influence on their cognitive functions, social functions, quality of life, alpha frequency… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- May 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed an informed consent, the patient must be able and willing to participate in a research study,
- Undergo an examination by international neuropsychiatric questionnaire MINI - PLUS to confirm the diagnosis of schizophrenia
- schizophrenic illness duration longer than one year,
- have a stable and consistent drug treatment at least two weeks prior the rTMS treatment
- persistent negative symptoms without further psychiatric comorbidity (like depression, mania, anxiety disorders, personality disorders, etc.) in the foreground of the illness
- The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher and at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms),
- improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
Who cannot join
- involuntary stay in a psychiatric clinic during the recruitment of patients;
- clinically relevant unstable medical conditions;
- factors incompatible with the use of rTMS, such as pacemakers, heart pumps and other metal implants;
- history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG
- current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines (10mg/D or less of diazepam or equivalent dosage of other benzodiazepines);
- lack of cognitive skills for participation;
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- clinically relevant psychiatric comorbidity (any other axis 1 diagnosis) detected using MINI Plus, including the current abuse of drugs and alcohol;
- heart attack or traumatic head injury in the anamnesis
- Patient unable to undergo a brain MRI
- Acute risk of suicide;
- knowledge of Czech language at a level that does not allow fill the required test battery;
- pregnancy
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Departement of psychiatry, University Hospital
Brno, Czech Republic, 62500
Tomáš Svěrák, Mgr., +420737504353, 362515@mail.muni.cz
Michaela Mayerová, MUDr.
About this study
Official title: High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study
The main purpose of this study is to determine whether intensive repetitive transcranial magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in schizophrenia patients and whether it has a positive influence on their cognitive functions, social functions, quality of life, alpha frequency and cortical silent period changes. Also, this study should provide data about safety and tolerability this I-rTMS treatment in schizophrenia patients.
Read the detailed description
Patients undergo 5x EEG from safety and research reasons during the study. Stimulation coil location (left DLPFC) is determined by magnetic resonance imaging (1,5T, 3D- TFE, voxel size 1 x 1 x 1 mm, Intera MR scanner) and stereotactic neuronavigation (Brainsight Frameless).
Patients are evaluated by several psychiatric scales. Positive and negative symptom scale (PANSS) is applied before the first stimulation, at the end of every stimulation day and two weeks after the last stimulation (a total 6). Other psychiatric evaluations used are Clinical global impression (CGI), Sheehan disability scale (SDS), Personal and social performance scale (PSP) and Montgomery-Asberg Depression Scale (MADRS), Calgary depression scale for schizophrenia (CDSS); (MADRS and CDSS are for the exclusion of depression). These scales were used only before the start of the first stimulation, after its completion and two weeks after the last test.
- Conditions
- Schizophrenia
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation with sham coil
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Negative symptoms, Intensive, Transcranial Magnetic Stimulation, Repetitive
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called Magstim Rapid 2
16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. pause is between every stimulation session for safety reasons.v
Transcranial Magnetic Stimulation with sham coilDevice
Also called Magstim Rapid 2 with sham coil
16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. Pause is between every stimulation session for safety reasons.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Active Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) Receives: Device: Transcranial Magnetic Stimulation |
| Transcranial Magnetic Stimulation with sham coil | Sham comparator | Sham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) Receives: Device: Transcranial Magnetic Stimulation with sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)
Measured: Baseline, Week 3
Secondary outcomes (1)
Number of Participants with Serious and Non-Serious Adverse Events
Patients undergoing five times EEG during the study for safety reasons. The researcher assigns patients on their health and mental condition by Visual Analogous Scale every day before and after rTMS stimulation.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Tomáš Svěrák, Masaryk University
- Investigators
- Tomáš Svěrák, Mgr., Principal investigator, Brno University HospitalRadovan Přikryl, Prof., Study director, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127879
- Sponsor's protocol ID
- TSRPMMLA1
- Other IDs
- 61300
- Status last verified
- May 2014
- First submitted
- 26 Apr 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study
- ClinicalTrials.gov ID
- NCT02127879
- Acronym / sponsor ID
- TSRPMMLA1
- Conditions
- Schizophrenia
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Negative symptoms, Intensive, Transcranial Magnetic Stimulation, Repetitive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- May 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 1 May 2014 (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.
The main purpose of this study is to determine whether intensive repetitive transcranial magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in schizophrenia patients and whether it has a positive influence on their cognitive functions, social functions, quality of life, alpha frequency and cortical silent period changes. Also, this study should provide data about safety and tolerability this I-rTMS treatment in schizophrenia patients.
Detailed description
Patients undergo 5x EEG from safety and research reasons during the study. Stimulation coil location (left DLPFC) is determined by magnetic resonance imaging (1,5T, 3D- TFE, voxel size 1 x 1 x 1 mm, Intera MR scanner) and stereotactic neuronavigation (Brainsight Frameless).
Patients are evaluated by several psychiatric scales. Positive and negative symptom scale (PANSS) is applied before the first stimulation, at the end of every stimulation day and two weeks after the last stimulation (a total 6). Other psychiatric evaluations used are Clinical global impression (CGI), Sheehan disability scale (SDS), Personal and social performance scale (PSP) and Montgomery-Asberg Depression Scale (MADRS), Calgary depression scale for schizophrenia (CDSS); (MADRS and CDSS are for the exclusion of depression). These scales were used only before the start of the first stimulation, after its completion and two weeks after the last test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic StimulationActive Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) |
| Transcranial Magnetic Stimulation with sham coil | Sham comparator | Device: Transcranial Magnetic Stimulation with sham coilSham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed an informed consent, the patient must be able and willing to participate in a research study,
- Undergo an examination by international neuropsychiatric questionnaire MINI - PLUS to confirm the diagnosis of schizophrenia
- schizophrenic illness duration longer than one year,
- have a stable and consistent drug treatment at least two weeks prior the rTMS treatment
- persistent negative symptoms without further psychiatric comorbidity (like depression, mania, anxiety disorders, personality disorders, etc.) in the foreground of the illness
Key exclusion criteria (12 listed)
- involuntary stay in a psychiatric clinic during the recruitment of patients;
- clinically relevant unstable medical conditions;
- factors incompatible with the use of rTMS, such as pacemakers, heart pumps and other metal implants;
- history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG
- current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines (10mg/D or less of diazepam or equivalent dosage of other benzodiazepines);
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: Magstim Rapid 216 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. pause is between every stimulation session for safety reasons.v | Device | Transcranial Magnetic Stimulation |
| Transcranial Magnetic Stimulation with sham coilAlso: Magstim Rapid 2 with sham coil16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. Pause is between every stimulation session for safety reasons. | Device | Transcranial Magnetic Stimulation with sham coil |
Primary outcome
Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, Week 3
1 secondary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
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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.
Tomáš Svěrák, Mgr. principal investigator
Brno University Hospital
Radovan Přikryl, Prof. study director
Brno University 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 Transcranial Magnetic Stimulation in people with Schizophrenia, run by Brno University Hospital at 1 site in Czechia.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 May 2014. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomáš Svěrák, Mgr. (+420737504353, 362515@mail.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline, Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2014.