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NCT00517400 Clinical Trial

Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title:
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517400
Other study ID # 364/3.8.07(HMO)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 16, 2007
Last updated April 19, 2015
Start date February 2008
Est. completion date July 2011

Study information
Verified date July 2010
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health, Health Technology and Infrastructure Administration, Medical Device Department
Study type Interventional

Clinical Trial Summary

Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).

Comparing real to sham treatment.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- PTSD diagnosis per DSM IV

Exclusion Criteria:

- Schizophrenia

- Bipolar I

- severe Axis II diagnosis

- risk factors to convulsions

- drug / alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham

Locations
Country Name City State
Israel Psychiatric department, Hadassah-Hebrew universityMedical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Isserles M, Shalev AY, Roth Y, Peri T, Kutz I, Zlotnick E, Zangen A. Effectiveness of deep transcranial magnetic stimulation combined with a brief exposure procedure in post-traumatic stress disorder--a pilot study. Brain Stimul. 2013 May;6(3):377-83. doi — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary CAPS SCORE [TOTAL, INTRUSION] 4 weeks No
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