Post Traumatic Stress DisorderPhase 1/2NCT00517400
Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder
A Phase 1/2 study of Post Traumatic Stress Disorder, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD diagnosis per DSM IV
Who cannot join
- Schizophrenia
- Bipolar I
- severe Axis II diagnosis
- risk factors to convulsions
- drug / alcohol abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site
Psychiatric department, Hadassah-Hebrew universityMedical Organization
Jerusalem
About this study
Official title: Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder
Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).
Comparing real to sham treatment.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or shamDevice
Also called Brainsway H-Coil
| Study group | Role | What they receive |
|---|---|---|
| Exposure-Stimulation | Active comparator | Not described Receives: Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham |
| Sham exposure - Real stimulation | Active comparator | Not described Receives: Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham |
| Exposure - Sham Stimulation | Active comparator | Not described Receives: Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS SCORE [TOTAL, INTRUSION]
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Moshe Isserles, MD, MSc, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517400
- Sponsor's protocol ID
- 364/3.8.07(HMO)
- Status last verified
- Jul 2010
- First submitted
- 16 Aug 2007
- Last updated
- 21 Apr 2015
- Results posted
- No
Publications
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.
PubMed 22921765
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00517400
- Acronym / sponsor ID
- 364/3.8.07(HMO)
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).
Comparing real to sham treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PTSD diagnosis per DSM IV
Key exclusion criteria (5 listed)
- Schizophrenia
- Bipolar I
- severe Axis II diagnosis
- risk factors to convulsions
- drug / alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or shamAlso: Brainsway H-Coil | Device | Exposure - Sham Stimulation, Exposure-Stimulation, Sham exposure - Real stimulation |
Primary outcome
CAPS SCORE [TOTAL, INTRUSION]
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Results publication: PubMed 22921765Isserles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Isserles, MD, MSc principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Post Traumatic Stress Disorder, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPS SCORE [TOTAL, INTRUSION] (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00517400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.