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Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation with sham coil
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Negative symptoms, Intensive, Transcranial Magnetic Stimulation, Repetitive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of psychiatry, University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation with sham coil

Arm Description

Active Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)

Sham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)

Outcomes

Primary Outcome Measures

Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)

Secondary Outcome Measures

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.

Full Information

First Posted
April 26, 2014
Last Updated
May 2, 2014
Sponsor
Brno University Hospital
Collaborators
Masaryk University
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1. Study Identification

Unique Protocol Identification Number
NCT02127879
Brief Title
Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia
Official Title
High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital
Collaborators
Masaryk University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Negative symptoms, Intensive, Transcranial Magnetic Stimulation, Repetitive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Experimental
Arm Description
Active Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)
Arm Title
Transcranial Magnetic Stimulation with sham coil
Arm Type
Sham Comparator
Arm Description
Sham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
Magstim Rapid 2
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation with sham coil
Other Intervention Name(s)
Magstim Rapid 2 with sham coil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)
Time Frame
Baseline, Week 3
Secondary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
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.
Time Frame
Up to 5 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in quality of life in the Quality of Life questionaire (SQUALA) at week 3
Time Frame
At baseline, Week 3
Title
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
Description
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
Time Frame
Baseline, Week 3
Title
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
Title
Change from baseline in global clinical improvement measured by Clinical Global Impression (CGI) at week 3
Time Frame
Baseline, Week 3
Title
Change from baseline in alpha frequency measured by EEG at week 3
Time Frame
Baseline, Week 3
Title
Change from baseline in cortical silent period measured by transcranial magnetic stimulation at week 3
Time Frame
Baseline, Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomáš Svěrák, Mgr.
Phone
+420737504353
Email
362515@mail.muni.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomáš Svěrák, Mgr.
Organizational Affiliation
Brno University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Radovan Přikryl, Prof.
Organizational Affiliation
Brno University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Departement of psychiatry, University Hospital
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomáš Svěrák, Mgr.
Phone
+420737504353
Email
362515@mail.muni.cz
First Name & Middle Initial & Last Name & Degree
Michaela Mayerová, MUDr.
First Name & Middle Initial & Last Name & Degree
Radovan Přikryl, Prof.
First Name & Middle Initial & Last Name & Degree
Tomáš Svěrák, Mgr.

12. IPD Sharing Statement

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Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia

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