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Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia

Primary Purpose

Schizophrenia

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

H1 deep TMS coil

Sham

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, TMS, brain stimulation, negative symptoms, clinical improvement, cognitive improvement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
Right hand dominant.
Scores in PANSS negative questionnaire above 21.
Gave informed consent for participation in the study.
Negative answers on safety screening questionnaire for transcranial magnetic stimulation
stable on the same antipsychotic medication for at least two months prior to entering the study.
Negative answers to all questions in the TMS safety questionnaire (attached ).

Exclusion Criteria:

Diagnosed as suffering from another axis 1 disorder .
Scores in PANSS positive questionnaire above 24.
History of epilepsy, seizure, or hot spasm.
History of epilepsy within first-degree relatives.
History of head injuries.
History of metal in the head (outside the mouth space).
History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
History of migraines.
History of hearing loss (not due to aging) or cochlear implants.
History of drug or alcohol abuse during the last year.
Women - Pregnancy or not using a reliable method of birth control.
Inability to achieve satisfying level of communication with the subject.
suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
Custodians.
Participation in another medical study during the experiment.

Sites / Locations

Shalvata Mental Helath CenterRecruiting
Shalvata

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

deep TMS treatment

inactive treatment

Outcomes

Primary Outcome Measures

SANS

Secondary Outcome Measures

SOFAS

Full Information

NCT ID

NCT00685321

First Posted

May 25, 2008

Last Updated

January 4, 2012

Sponsor

Shalvata Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT00685321

Brief Title

Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia

Official Title

A Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics. Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be recruited from both academic and private research centers. Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated. Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia, TMS, brain stimulation, negative symptoms, clinical improvement, cognitive improvement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

deep TMS treatment

Arm Title

Arm Type

Sham Comparator

Arm Description

inactive treatment

Intervention Type

Device

Intervention Name(s)

H1 deep TMS coil

Intervention Description

20 daily deep rTMS treatment

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

inactive treatment

Primary Outcome Measure Information:

Title

SANS

Time Frame

1.5 year

Secondary Outcome Measure Information:

Title

SOFAS

Time Frame

1.5 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria. Right hand dominant. Scores in PANSS negative questionnaire above 21. Gave informed consent for participation in the study. Negative answers on safety screening questionnaire for transcranial magnetic stimulation stable on the same antipsychotic medication for at least two months prior to entering the study. Negative answers to all questions in the TMS safety questionnaire (attached ). Exclusion Criteria: Diagnosed as suffering from another axis 1 disorder . Scores in PANSS positive questionnaire above 24. History of epilepsy, seizure, or hot spasm. History of epilepsy within first-degree relatives. History of head injuries. History of metal in the head (outside the mouth space). History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump. History of migraines. History of hearing loss (not due to aging) or cochlear implants. History of drug or alcohol abuse during the last year. Women - Pregnancy or not using a reliable method of birth control. Inability to achieve satisfying level of communication with the subject. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire Custodians. Participation in another medical study during the experiment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

liron rabani, Phd. student

Phone

972-97478644

lironrab@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yechiel levkovitz, MD

Organizational Affiliation

Shalvate mental health center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shalvata Mental Helath Center

City

Hod Hasharon

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hilik Levkovitz, prof.

Phone

972-9-7478569

ylevk@clalit.org.il

Facility Name

Shalvata

City

Hod hasharon

Country

Israel

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

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Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia

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