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

NCT ID: NCT00517400

Last Updated: 2015-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-07-31

Brief Summary

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

Comparing real to sham treatment.

Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exposure-Stimulation

Group Type ACTIVE_COMPARATOR

Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham

Intervention Type DEVICE

Sham exposure - Real stimulation

Group Type ACTIVE_COMPARATOR

Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham

Intervention Type DEVICE

Exposure - Sham Stimulation

Group Type ACTIVE_COMPARATOR

Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham

Intervention Type DEVICE

Interventions

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Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham

Intervention Type DEVICE

Other Intervention Names

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Brainsway H-Coil

Eligibility Criteria

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Inclusion Criteria

* PTSD diagnosis per DSM IV

Exclusion Criteria

* Schizophrenia
* Bipolar I
* severe Axis II diagnosis
* risk factors to convulsions
* drug / alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Principal Investigators

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Moshe Isserles, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Psychiatric department, Hadassah-Hebrew universityMedical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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: 10.1016/j.brs.2012.07.008. Epub 2012 Aug 18.

Reference Type RESULT
PMID: 22921765 (View on PubMed)

Other Identifiers

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364/3.8.07(HMO)

Identifier Type: -

Identifier Source: org_study_id

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