NCT02127879

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

April 26, 2014

Last Update Submit

May 2, 2014

Conditions

Schizophrenia

Keywords

Repetitive Transcranial Magnetic StimulationSchizophreniaNegative symptomsIntensiveTranscranial Magnetic Stimulation, Repetitive

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Week 3

Secondary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    Up to 5 weeks

Other Outcomes (6)

  • Change from baseline in quality of life in the Quality of Life questionaire (SQUALA) at week 3

    At baseline, Week 3

  • 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

    Baseline, Week 3

  • Change from baseline in social functions measured by Sheehan Disability Scale (SDS) and by Personal and Social Performance Scale (PSP) at week 3

    Baseline, Week 3

  • +3 more other outcomes

Study Arms (2)

Transcranial Magnetic Stimulation

EXPERIMENTAL

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

Device: Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation with sham coil

SHAM COMPARATOR

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

Device: Transcranial Magnetic Stimulation with sham coil

Interventions

Transcranial Magnetic StimulationDEVICE

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

Also known as: Magstim Rapid 2
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation with sham coilDEVICE

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.

Also known as: Magstim Rapid 2 with sham coil
Transcranial Magnetic Stimulation with sham coil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of psychiatry, University Hospital

Brno, Czech Republic, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Tomáš Svěrák, Mgr.

    Brno University Hospital

    PRINCIPAL INVESTIGATOR

  • Radovan Přikryl, Prof.

    Brno University Hospital

    STUDY DIRECTOR

Central Study Contacts

Tomáš Svěrák, Mgr.

CONTACT

+420737504353362515@mail.muni.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mgr.

Study Record Dates

First Submitted

April 26, 2014

First Posted

May 1, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

CZ(1)