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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00685321
First received: May 25, 2008
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Schizophrenia
Device: H1 deep TMS coil
Device: Sham

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

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • SANS [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • SOFAS [ Time Frame: 1.5 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: June 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
deep TMS treatment
Device: H1 deep TMS coil
20 daily deep rTMS treatment
Sham Comparator: 2
inactive treatment
Device: Sham
inactive treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685321

Contacts
Contact: liron rabani, Phd. student 972-97478644 lironrab@clalit.org.il

Locations
Israel
Shalvata Mental Helath Center Recruiting
Hod Hasharon, Israel
Contact: Hilik Levkovitz, prof.    972-9-7478569    ylevk@clalit.org.il   
Shalvata Not yet recruiting
Hod hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: yechiel levkovitz, MD Shalvate mental health center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00685321     History of Changes
Other Study ID Numbers: 0024-07-SHA
Study First Received: May 25, 2008
Last Updated: January 4, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
schizophrenia
TMS
brain stimulation
negative symptoms
clinical improvement
cognitive improvement

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014