Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia

NCT ID: NCT02127879

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-10-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Transcranial Magnetic Stimulation

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

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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 coil

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

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation with sham coil

Intervention Type: DEVICE

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.

Interventions

Transcranial Magnetic Stimulation

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

Transcranial Magnetic Stimulation 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.

Intervention Type: DEVICE

Other Intervention Names

Magstim Rapid 2; Magstim Rapid 2 with sham coil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk University

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tomáš Svěrák

Mgr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomáš Svěrák, Mgr.

Role: PRINCIPAL_INVESTIGATOR

Brno University Hospital

Radovan Přikryl, Prof.

Role: STUDY_DIRECTOR

Brno University Hospital

Locations

Departement of psychiatry, University Hospital

Brno, Czech Republic, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Tomáš Svěrák, Mgr.

Role: CONTACT

362515@mail.muni.cz

+420737504353

Facility Contacts

Tomáš Svěrák, Mgr.

Role: primary

362515@mail.muni.cz

+420737504353

Other Identifiers

61300

Identifier Type: OTHER

Identifier Source: secondary_id

TSRPMMLA1

Identifier Type: -

Identifier Source: org_study_id