Back to resultsEvaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
deep TMS H-coil
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- DSM IV Diagnosis of Schizophrenia
- PANNS Negative > 21
Exclusion Criteria:
- risk factors for convulsions
- PANNS positive > 24
Sites / Locations
- Shalvata MHC
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00445926
First Posted
March 8, 2007
Last Updated
May 5, 2010
Sponsor
Shalvata Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00445926
Brief Title
Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia
Official Title
Deep TMS With the H Coils as a Novel Strategy for the Treatment of Negative Symptoms of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shalvata Mental Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
deep TMS H-coil
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM IV Diagnosis of Schizophrenia
PANNS Negative > 21
Exclusion Criteria:
risk factors for convulsions
PANNS positive > 24
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eiran V Harel, MD
Organizational Affiliation
Shalvata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata MHC
City
Hod Hasharon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia
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