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

May 25, 2008
January 4, 2012
June 2008
January 2013   (final data collection date for primary outcome measure)
SANS [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00685321 on ClinicalTrials.gov Archive Site
SOFAS [ Time Frame: 1.5 Year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Device: H1 deep TMS coil
    20 daily deep rTMS treatment
  • Device: Sham
    inactive treatment
  • Experimental: 1
    deep TMS treatment
    Intervention: Device: H1 deep TMS coil
  • Sham Comparator: 2
    inactive treatment
    Intervention: Device: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: liron rabani, Phd. student 972-97478644 lironrab@clalit.org.il
Israel
 
NCT00685321
0024-07-SHA
Yes
Shalvata Mental Health Center
Shalvata Mental Health Center
Not Provided
Principal Investigator: yechiel levkovitz, MD Shalvate mental health center
Shalvata Mental Health Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP