- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127879
Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia
High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tomáš Svěrák, Mgr.
- Phone Number: +420737504353
- Email: 362515@mail.muni.cz
Study Locations
-
-
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Brno, Czech Republic, 62500
- Recruiting
- Departement of psychiatry, University Hospital
-
Contact:
- Tomáš Svěrák, Mgr.
- Phone Number: +420737504353
- Email: 362515@mail.muni.cz
-
Sub-Investigator:
- Michaela Mayerová, MUDr.
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Principal Investigator:
- Radovan Přikryl, Prof.
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Principal Investigator:
- Tomáš Svěrák, Mgr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcranial Magnetic Stimulation
Active Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)
|
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
Other Names:
|
Sham Comparator: Transcranial Magnetic Stimulation with sham coil
Sham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)
Time Frame: Baseline, Week 3
|
Baseline, Week 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: Up to 5 weeks
|
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.
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Up to 5 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in quality of life in the Quality of Life questionaire (SQUALA) at week 3
Time Frame: At baseline, Week 3
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At baseline, Week 3
|
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Change from baseline in cognitive functions measured by Verbal learning test, Rey- Osterrieth complex figure, D2 test, Repeating numbers memory test, London tower test, Verbal fluency test at week 3
Time Frame: Baseline, Week 3
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Verbal learning test testing memory (based on Rey Auditory Verbal Learning Test), Rey- Osterrieth complex figure testing testing sensomotoric and visuospatial skills, D2 test testing attention, Repeating numbers memory test testing working memory, London Tower test testing executive functions and Verbal fluency test testing verbal fluency and recalling of words
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Baseline, Week 3
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Change from baseline in social functions measured by Sheehan Disability Scale (SDS) and by Personal and Social Performance Scale (PSP) at week 3
Time Frame: Baseline, Week 3
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Baseline, Week 3
|
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Change from baseline in global clinical improvement measured by Clinical Global Impression (CGI) at week 3
Time Frame: Baseline, Week 3
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Baseline, Week 3
|
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Change from baseline in alpha frequency measured by EEG at week 3
Time Frame: Baseline, Week 3
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Baseline, Week 3
|
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Change from baseline in cortical silent period measured by transcranial magnetic stimulation at week 3
Time Frame: Baseline, Week 3
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Baseline, Week 3
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tomáš Svěrák, Mgr., Brno University Hospital
- Study Director: Radovan Přikryl, Prof., Brno University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSRPMMLA1
- 61300 (Other Identifier: Department of Psychiatry, Faculty of Medicine, Masaryk University, Brno, Czech Republic)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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