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

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Sham; Device: H1 deep TMS coil

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: liron rabani, Phd. student; Phone Number: 972-97478644; Email: lironrab@clalit.org.il

Study Locations

• Israel
  • Hod Hasharon, Israel
    • Recruiting
    • Shalvata Mental Helath Center
    • Contact: Hilik Levkovitz, prof.; Phone Number: 972-9-7478569; Email: ylevk@clalit.org.il
  • Hod hasharon, Israel
    • Not yet recruiting
    • Shalvata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; deep TMS treatment	Device: H1 deep TMS coil; 20 daily deep rTMS treatment
Sham Comparator: 2; inactive treatment	Device: Sham; inactive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SANS	1.5 year

Secondary Outcome Measures

Outcome Measure	Time Frame
SOFAS	1.5 Year

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center
• Investigators: Principal Investigator: yechiel levkovitz, MD, Shalvate mental health center

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: May 25, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: schizophrenia; TMS; brain stimulation; negative symptoms; cognitive improvement; clinical improvement
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: 0024-07-SHA