Post-Traumatic Stress DisorderNCT02479906
A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
A study testing Deep TMS System in people with Post-Traumatic Stress Disorder, run by Brainsway at 15 sites in 3 countries.
Trial summary
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD. Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Deep TMS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 17 Nov 2016to 31 Mar 2020
- Phase
- Interventional
- 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 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- Men and women 22-68 years of age
- Subjects currently diagnosed with PTSD according to the DSM-5, using the CAPS-5 (past-month version), with the following criteria met:
- Criterion B: at least 1/5 intrusion symptoms; and
- Criteria C: at least 1/2 avoidance symptoms; and
- Criteria D: at least 2/7 cognition \& mood symptoms; and
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- Criteria E: at least 2/6 arousal \& reactivity symptoms; and
- Criterion F: duration is met; and
- Criteria G: distress is met.
- Subjects with at least moderate PTSD with a CAPS-5 score ≥ 25 at both Screening and Baseline visits.
- Subjects with an HDRS-21 score ≤ 26 at both Screening and Baseline visits.
- Subjects with negative or mitigated answers on safety screening questionnaire for transcranial magnetic stimulation.
- Negative pregnancy test in childbearing age women.
- Subject is capable and willing to provide informed consent.
- Subject is able to adhere to the treatment schedule.
Who cannot join
- Subject diagnosed according to the SCID I as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when HDRS-21≤26).
- Subjects diagnosed according to the SCID II as suffering from Severe Personality Disorder.
- Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.
- Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.
- Subject has a history of cranial surgery.
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- Subject has metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- Subject has severe and frequent headaches.
- Subject has a history of significant hearing loss.
- Subjects with a significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- MMSE ≤ 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Subject with a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
- Inadequate communication with the patient.
- Subject is under custodial care.
- Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- Subject with unstable physical disease such as unstable cardiac disease.
- Subject is currently on Benzodiazepine at a dose higher than 3 mg of Lorazepam or equivalent.
- Subject has had previous treatment with TMS.
- Women who are breast-feeding.
- Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States12 sites
Medical University Of South Carolina (MUSC)
Charleston, South Carolina, 29425
Yellowbrick Foundation
Evanston, Illinois, 60201
University of Florida College of Medicine
Gainesville, Florida, 32603
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
CalNeuro Research Group
Los Angeles, California, 90024
TMS Hope Center of Long Island
New York, New York, 11777
Advanced Mental Health Care Inc.-Palm Beach
Palm Beach, Florida, 33411
Stanford University
Palo Alto, California, CA 94304-1212
Carolina Partners in Mental Healthcare PLLC
Raleigh, North Carolina
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
University of California - San Diego Medical Center
San Diego, California, 92103
Kadima Neuropsychiatry
San Diego, California
Israel2 sites
Be'er Yaacov Mental Health Center
Be’er Ya‘aqov, 70350
Tel Hashomer Hospital
Tel HaShomer, 52621
About this study
Official title: A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) Deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD)
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.
Read the detailed description
Deep TMS in conjunction with brief trauma exposure will be compared to sham treatment in conjunction with brief trauma exposure, in a multicenter, randomized, controlled study for the treatment of PTSD. Study duration is 9 weeks, consisting of 4 weeks of treatment and a 5 week and 9 week follow-up visit. Subjects will be randomized to real or sham treatment stratified by site. The design is meant to demonstrate that the device shows superiority compared to sham treatment at the 5 week follow-up visit and at the 9 week follow-up visit, 1 month post-treatment.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Deep TMS System, Sham Treatment
- Keywords
- Post-Traumatic Stress Disorder, PTSD, dTMS
- 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 TMS SystemDevice
Deep TMS treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions.
Sham TreatmentDevice
Sham treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions
| Study group | Role | What they receive |
|---|---|---|
| Sham Treatment | Sham comparator | In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain. Receives: Device: Sham Treatment |
| Deep TMS System | Experimental | Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The HAC Coil is designed to stimulate neuronal pathways in the medial prefrontal cortex or motor cortex, including the anterior cingulated cortex. Receives: Device: Deep TMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS-5 Score
CAPS-5 Score measured by change from baseline.
Measured: 5 weeks from baseline
Secondary outcomes (1)
Response Rate
Response rate at the 5 week follow-up visit.
Measured: 5 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start17 Nov 2016
- Primary completion6 Feb 2020
- Study completion31 Mar 2020
Why it stopped: The results did not demonstrate sufficient clinical benefit induced specifically by the active treatment to justify continuation of the trial.
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Isserles, MD, Principal investigator, Hadassah Ein Karem Medical Center and Center for Addiction and Mental Health (CAMH)Zafiris J. Daskalakis, MD, Principal investigator, Center for Addiction and Mental Health (CAMH)Avraham Zangen, PhD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479906
- Sponsor's protocol ID
- CTP-PTSD-01
- Status last verified
- May 2020
- First submitted
- 15 Jun 2015
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Isserles M, Tendler A, Roth Y, Bystritsky A, Blumberger DM, Ward H, Feifel D, Viner L, Duffy W, Zohar J, Keller CJ, Bhati MT, Etkin A, George MS, Filipcic I, Lapidus K, Casuto L, Vaishnavi S, Stein A, Deutsch L, Deutsch F, Morales O, Daskalakis ZJ, Zangen A, Ressler KJ. Deep Transcranial Magnetic Stimulation Combined With Brief Exposure for Posttraumatic Stress Disorder: A Prospective Multisite Randomized Trial. Biol Psychiatry. 2021 Nov 15;90(10):721-728. doi: 10.1016/j.biopsych.2021.04.019. Epub 2021 May 4.
PubMed 34274108
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) Deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02479906
- Acronym / sponsor ID
- CTP-PTSD-01
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post-Traumatic Stress Disorder, PTSD, dTMS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results did not demonstrate sufficient clinical benefit induced specifically by the active treatment to justify continuation of the trial.
- Enrolment
- 203 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Jun 2015 (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.
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.
Detailed description
Deep TMS in conjunction with brief trauma exposure will be compared to sham treatment in conjunction with brief trauma exposure, in a multicenter, randomized, controlled study for the treatment of PTSD. Study duration is 9 weeks, consisting of 4 weeks of treatment and a 5 week and 9 week follow-up visit. Subjects will be randomized to real or sham treatment stratified by site. The design is meant to demonstrate that the device shows superiority compared to sham treatment at the 5 week follow-up visit and at the 9 week follow-up visit, 1 month post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Treatment | Sham comparator | Device: Sham TreatmentIn the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain. |
| Deep TMS System | Experimental | Device: Deep TMS SystemDeep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The HAC Coil is designed to stimulate neuronal pathways in the medial prefrontal cortex or motor cortex, including the anterior cingulated cortex. |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Outpatients
- Men and women 22-68 years of age
- Subjects currently diagnosed with PTSD according to the DSM-5, using the CAPS-5 (past-month version), with the following criteria met:
- Subjects with at least moderate PTSD with a CAPS-5 score ≥ 25 at both Screening and Baseline visits.
- Subjects with an HDRS-21 score ≤ 26 at both Screening and Baseline visits.
Key exclusion criteria (28 listed)
- Subject diagnosed according to the SCID I as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when HDRS-21≤26).
- Subjects diagnosed according to the SCID II as suffering from Severe Personality Disorder.
- Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.
- Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.
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 TMS SystemDeep TMS treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions. | Device | Deep TMS System |
| Sham TreatmentSham treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions | Device | Sham Treatment |
Primary outcome
CAPS-5 Score
Time frame: 5 weeks from baseline
CAPS-5 Score measured by change from baseline.
1 secondary outcome
Response Rate
Time frame: 5 weeks from baseline
Results and safety
The study was stopped early (reason given: The results did not demonstrate sufficient clinical benefit induced specifically by the active treatment to justify continuation of the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 34274108Isserles M, Tendler A, Roth Y, Bystritsky A, Blumberger DM, Ward H, Feifel D, Viner L, Duffy W, Zohar J, Keller CJ, Bhati MT, Etkin A, George MS, Filipcic I, Lapidus K, Casuto L, Vaishnavi S, Stein A, Deutsch L, Deutsch F, Morales O, Daskalakis ZJ, Zangen A, Ressler KJ. Deep Transcranial Magnetic Stimulation Combined With Brief Exposure for Posttraumatic Stress Disorder: A Prospective Multisite Randomized Trial. Biol Psychiatry. 2021 Nov 15;90(10):721-728. doi: 10.1016/j.biopsych.2021.04.019. Epub 2021 May 4.
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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 principal investigator
Hadassah Ein Karem Medical Center and Center for Addiction and Mental Health (CAMH)
Zafiris J. Daskalakis, MD principal investigator
Center for Addiction and Mental Health (CAMH)
Avraham Zangen, PhD principal investigator
Ben-Gurion University of the Negev
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep TMS System in people with Post-Traumatic Stress Disorder, run by Brainsway at 15 sites in 3 countries.
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 15 inclusion and 28 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: stopped early, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Israel, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The results did not demonstrate sufficient clinical benefit induced specifically by the active treatment to justify continuation of the trial.). Results are not available in the source record.
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-5 Score (time frame: 5 weeks from baseline). 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 NCT02479906, 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 14 May 2020.