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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00685321
• Other study ID #: 0024-07-SHA
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2008
• Last updated: January 4, 2012
• Start date: June 2008
• Est. completion date: January 2013

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: liron rabani, Phd. student
• Phone: 972-97478644
• Email: lironrab[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Right hand dominant.

3. Scores in PANSS negative questionnaire above 21.

4. Gave informed consent for participation in the study.

5. Negative answers on safety screening questionnaire for transcranial magnetic stimulation

6. stable on the same antipsychotic medication for at least two months prior to entering the study.

7. Negative answers to all questions in the TMS safety questionnaire (attached ).

Exclusion Criteria:

1. Diagnosed as suffering from another axis 1 disorder .

2. Scores in PANSS positive questionnaire above 24.

3. History of epilepsy, seizure, or hot spasm.

4. History of epilepsy within first-degree relatives.

5. History of head injuries.

6. History of metal in the head (outside the mouth space).

7. History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.

8. History of migraines.

9. History of hearing loss (not due to aging) or cochlear implants.

10. History of drug or alcohol abuse during the last year.

11. Women - Pregnancy or not using a reliable method of birth control.

12. Inability to achieve satisfying level of communication with the subject.

13. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire

14. Custodians.

15. Participation in another medical study during the experiment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Schizophrenia

Intervention

Device:
• H1 deep TMS coil
20 daily deep rTMS treatment
• Sham
inactive treatment

Locations

Country	Name	City	State
Israel	Shalvata	Hod hasharon
Israel	Shalvata Mental Helath Center	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SANS		1.5 year	Yes
Secondary	SOFAS		1.5 Year	No