Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
This study is currently recruiting participants.
Verified January 2012 by Shalvata Mental Health Center
Sponsor:
Shalvata Mental Health Center
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
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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:
- 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.
Contacts and Locations
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 | Not yet recruiting |
| Hod hasharon, Israel | |
| Shalvata Mental Helath Center | Recruiting |
| Hod Hasharon, Israel | |
| Contact: Hilik Levkovitz, prof. 972-9-7478569 ylevk@clalit.org.il | |
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 May 23, 2013