NCT00517400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 21, 2015

Status Verified

July 1, 2010

Enrollment Period

3.3 years

First QC Date

August 16, 2007

Last Update Submit

April 19, 2015

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

  • CAPS SCORE [TOTAL, INTRUSION]

    4 weeks

Study Arms (3)

Exposure-Stimulation

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

Sham exposure - Real stimulation

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

Exposure - Sham Stimulation

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

Interventions

Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or shamDEVICE
Also known as: Brainsway H-Coil
Exposure - Sham StimulationExposure-StimulationSham exposure - Real stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PTSD diagnosis per DSM IV

You may not qualify if:

  • Schizophrenia
  • Bipolar I
  • severe Axis II diagnosis
  • risk factors to convulsions
  • drug / alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric department, Hadassah-Hebrew universityMedical Organization

Jerusalem, Israel

Location

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

    PMID: 22921765RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Moshe Isserles, MD, MSc

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

February 1, 2008

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

April 21, 2015

Record last verified: 2010-07

Locations

IL(1)