Posttraumatic Stress DisorderNCT02158663
Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)
A study testing Repetitive Transcranial Magnetic Stimulation in people with Posttraumatic Stress Disorder and Depression, run by James A. Haley Veterans Administration Hospital at 1 site in United States.
Trial summary
Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2014to 14 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female veteran outpatients aged 18-50 years old
- Meet DSM-IV criteria for PTSD as determined by clinical interview and CAPS for DSM-5
- A PTSD checklist - (PCL) ≥ 45 at Screening/Baseline
- On stable medication and/or psychotherapy for 1 month and clinically appropriate to maintain for duration of trial
- Clinically competent to give informed written consent
Who cannot join
- Veterans currently enrolled in an acute treatment of PTSD using evidence based psychotherapy including Prolonged Exposure Therapy (PE), Cognitive Processing Therapy (CPT), or Eye Movement Desensitization and Reprocessing (EMDR)
- History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident, metal in the skull, a history of major head trauma defined as greater than mild TBI, or any neurologic condition likely to increase risk of rTMS.
- Suicidal risk that precludes safe participation defined as clinical impression that the subject is at significant risk for suicide.
- Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder, bipolar disorder type I or II, dementia, dissociative disorders, or sexual and gender identity disorder
- Personality disorder that makes participation in the trial difficult
- History of problematic Substance Use Disorder in the last 3 months except nicotine and caffeine
Show all 15Show fewer
- Taking any medication that significantly lowers the seizure threshold (e.g., stimulants, theophylline, first generation antipsychotics, etc.)
- Unstable medical conditions that precludes safe participation in rTMS treatment trial
- Known or suspected pregnancy
- Nursing mothers
- Women of child-bearing potential not using medically accepted form of contraception when engaged in sexual intercourse
- Any metal or device implants that would increase risk of rTMS
- Unable to determine the motor threshold in the subject
- History of Vagus Nerve Stimulation or Electroconvulsive Therapy
- Currently in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of 1 Hz Versus 10 Hz Right Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Posttraumatic Stress Disorder (PTSD)
Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. The secondary objectives include: one, testing which treatment provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; three, testing which treatment is better tolerated as measured by participant drop out and side effect profiles.
Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
Methodology: Veterans 18-50 years of age suffering from PTSD with and without depressive symptoms will be recruited from the community as well as mental health clinics at James A. Haley Veterans Administration Hospital. Plan to enroll 50 to have an evaluable sample of approximately 20 in each group. Participants will be consented and undergo screening for safety and appropriateness to be in the trial. Those deemed eligible will be evaluated with clinical measures of function, PTSD, depression, pain, and neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by significant depression defined as MADRS greater than 19) to one of two active treatments: right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo assessment for safety prior to each treatment. The treatments will be performed 5 days a week for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per week. Clinical evaluations will be performed at baseline, after every five treatments, at the end of treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a significant difference in change in depressive symptoms for both the participants with significant depressive symptoms and the entire group. The number of dropouts (related specifically to side effects and all cause) will be used along with side effect profiles to test for differences in tolerability of the two treatments.
Read the detailed description
Participants wishing to participate will contact the study team either personally or through their provider at the Veteran's request. Further means of recruitment are as follows. 1) Flyers will be placed at the University of South Florida and other high learning institutions in the local area. 2)The study team will provide flyers and give talks at Veteran associated organizations. 3)The study will also be advertised on the JAH Facebook page as well as the JAH Twitter account. 4) Veterans with a PTSD diagnosis will be identified using the VSSC web reports. Using this method, the study staff will pre-screen the CPRS records of 5,000 veterans to identify potential subjects. The identified veterans will be sent a recruitment letter with detailed information about the study as well as a copy of the informed consent. After a 10-day waiting period, the study team will them contact the veteran by phone to see if they are interested in participating. The study team will review the Veteran's medical record and discuss the study and its entry criteria with the participants and/or provider. Those suitable to enter the trial and interested will be scheduled for a screening/baseline visit. These participants will typically be those who have either failed or are not willing to engage in standard evidence-based psychotherapy.
The screening/baseline visit will begin by acquiring written informed consent. Subsequently, evaluations to determine safety and appropriateness, as well as clinical ratings and laboratory testing (UDS and urine pregnancy testing) will be performed. Those deemed eligible will be randomized to 1 Hz versus 10 Hz stratified by significant depression (MADRS > 19) and treated on a subsequent day within a week. Participants will be treated for 5 days a week for 6 weeks with a 3-week taper (3 per week for 1 week, 2 per week for 1 week, 1 per week for 1 week). Participants will undergo clinical evaluation weekly for clinical effect during the treatment, at the end of the taper (or when participant chooses to leave the trial) and at 1- and 3-months post treatment. In addition, safety will be assessed prior to each treatment. The total time in study for a participant will be approximately 22 weeks.
Randomization will be stratified based on significant depressive symptoms which will be defined as a MADRS score > 19 versus MADRS score ≤ 19. Using a computer randomization schedule, an investigator not involved directly with the trial will generate two random lists of active and sham cards that will be placed in envelopes. The two groups will be MADRS score > 19 versus MADRS score ≤ 19. When the participant is ready to begin the first treatment, the treater will pull the next envelope in line for the appropriate group and open the envelope to determine the randomization assignment. The participant will know the assignment as well as the treater but the investigator doing all the clinician rating scales will be masked to assignment.
Medications and other treatments: Participants will be allowed to continue current medications and therapy as long as does not increase risk of rTMS and is held constant during the six weeks of the trial. Doses may be adjusted as need for side effects.
Materials obtained for research purposes include demographic information, contact information (for purposes of the study only), medical/psychiatric history (from interviews/ questionnaires), cognitive test data, laboratory data, and clinical data. All of the data will be obtained for research purposes.
Treatment with the Neurostar (Repetitive Transcranial Magnetic Stimulation) Stimulation System may involve other risks that are not known at the present time. The long-term effects of rTMS (Repetitive Transcranial Magnetic Stimulation) are not known. Legal and social risks of participation in this research are unknown.
The PI will monitor the safety of the participants to continue in the trial. The PI will be seeing the participants in person typically on at least a weekly basis. The PI will review the study data for side effects on an ongoing basis but more formally every 12 months to ensure no trends in the data of increased risk.
The data will only be used by the research team within the VA to address the research questions.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, TMS, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called NeuroStar chair (Neuronetics, Malvern, PA)
TMS Device
| Study group | Role | What they receive |
|---|---|---|
| Right slow prefrontal rTMS | Active comparator | Repetitive Transcranial Magnetic Stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Right fast prefrontal rTMS | Active comparator | Repetitive Transcranial Magnetic Stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Clinical-Administered Post Traumatic - DSM-5
Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.
Measured: Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Change in IPF: Inventory of Psychosocial Functioning
Change Inventory of Psychosocial Functioning (IPF) Administered at baseline and after 30 rTMS treatments. The IPF is an 80 question self-report scale that assessed function in the areas of family, work,friendships and socializing, parenting, education, self-care, and romantic relationships with spouse or partner. The rate is based on how often participant acted over the past 30 days. Domains are averaged with resulting score range 1 - 7. 1 Never - 7 Always.
Measured: Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study start6 Jun 2014
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- James A. Haley Veterans Administration Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, F. Andrew Kozel, M.D., M.S.C.R., James A. Haley Veterans Administration Hospital
- Investigators
- F. Andrew Kozel, MD, MSCR., Principal investigator, James A. Haley VAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158663
- Sponsor's protocol ID
- JAH TMS 15863
- Status last verified
- Apr 2020
- First submitted
- 30 May 2014
- Last updated
- 27 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kozel FA, Van Trees K, Larson V, Phillips S, Hashimie J, Gadbois B, Johnson S, Gallinati J, Barrett B, Toyinbo P, Weisman M, Centorino M, Gibson CA, Catalano G. One hertz versus ten hertz repetitive TMS treatment of PTSD: A randomized clinical trial. Psychiatry Res. 2019 Mar;273:153-162. doi: 10.1016/j.psychres.2019.01.004. Epub 2019 Jan 3.
PubMed 30641346
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of 1 Hz Versus 10 Hz Right Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02158663
- Acronym / sponsor ID
- JAH TMS 15863
- Conditions
- Posttraumatic Stress Disorder, Depression
- Keywords
- Transcranial Magnetic Stimulation, TMS, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- James A. Haley Veterans Administration HospitalUS federal agency
- Study start
- 6 Jun 2014 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. The secondary objectives include: one, testing which treatment provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; three, testing which treatment is better tolerated as measured by participant drop out and side effect profiles.
Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
Methodology: Veterans 18-50 years of age suffering from PTSD with and without depressive symptoms will be recruited from the community as well as mental health clinics at James A. Haley Veterans Administration Hospital. Plan to enroll 50 to have an evaluable sample of approximately 20 in each group. Participants will be consented and undergo screening for safety and appropriateness to be in the trial. Those deemed eligible will be evaluated with clinical measures of function, PTSD, depression, pain, and neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by significant depression defined as MADRS greater than 19) to one of two active treatments: right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo assessment for safety prior to each treatment. The treatments will be performed 5 days a week for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per week. Clinical evaluations will be performed at baseline, after every five treatments, at the end of treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a significant difference in change in depressive symptoms for both the participants with significant depressive symptoms and the entire group. The number of dropouts (related specifically to side effects and all cause) will be used along with side effect profiles to test for differences in tolerability of the two treatments.
Detailed description
Participants wishing to participate will contact the study team either personally or through their provider at the Veteran's request. Further means of recruitment are as follows. 1) Flyers will be placed at the University of South Florida and other high learning institutions in the local area. 2)The study team will provide flyers and give talks at Veteran associated organizations. 3)The study will also be advertised on the JAH Facebook page as well as the JAH Twitter account. 4) Veterans with a PTSD diagnosis will be identified using the VSSC web reports. Using this method, the study staff will pre-screen the CPRS records of 5,000 veterans to identify potential subjects. The identified veterans will be sent a recruitment letter with detailed information about the study as well as a copy of the informed consent. After a 10-day waiting period, the study team will them contact the veteran by phone to see if they are interested in participating. The study team will review the Veteran's medical record and discuss the study and its entry criteria with the participants and/or provider. Those suitable to enter the trial and interested will be scheduled for a screening/baseline visit. These participants will typically be those who have either failed or are not willing to engage in standard evidence-based psychotherapy.
The screening/baseline visit will begin by acquiring written informed consent. Subsequently, evaluations to determine safety and appropriateness, as well as clinical ratings and laboratory testing (UDS and urine pregnancy testing) will be performed. Those deemed eligible will be randomized to 1 Hz versus 10 Hz stratified by significant depression (MADRS > 19) and treated on a subsequent day within a week. Participants will be treated for 5 days a week for 6 weeks with a 3-week taper (3 per week for 1 week, 2 per week for 1 week, 1 per week for 1 week). Participants will undergo clinical evaluation weekly for clinical effect during the treatment, at the end of the taper (or when participant chooses to leave the trial) and at 1- and 3-months post treatment. In addition, safety will be assessed prior to each treatment. The total time in study for a participant will be approximately 22 weeks.
Randomization will be stratified based on significant depressive symptoms which will be defined as a MADRS score > 19 versus MADRS score ≤ 19. Using a computer randomization schedule, an investigator not involved directly with the trial will generate two random lists of active and sham cards that will be placed in envelopes. The two groups will be MADRS score > 19 versus MADRS score ≤ 19. When the participant is ready to begin the first treatment, the treater will pull the next envelope in line for the appropriate group and open the envelope to determine the randomization assignment. The participant will know the assignment as well as the treater but the investigator doing all the clinician rating scales will be masked to assignment.
Medications and other treatments: Participants will be allowed to continue current medications and therapy as long as does not increase risk of rTMS and is held constant during the six weeks of the trial. Doses may be adjusted as need for side effects.
Materials obtained for research purposes include demographic information, contact information (for purposes of the study only), medical/psychiatric history (from interviews/ questionnaires), cognitive test data, laboratory data, and clinical data. All of the data will be obtained for research purposes.
Treatment with the Neurostar (Repetitive Transcranial Magnetic Stimulation) Stimulation System may involve other risks that are not known at the present time. The long-term effects of rTMS (Repetitive Transcranial Magnetic Stimulation) are not known. Legal and social risks of participation in this research are unknown.
The PI will monitor the safety of the participants to continue in the trial. The PI will be seeing the participants in person typically on at least a weekly basis. The PI will review the study data for side effects on an ongoing basis but more formally every 12 months to ensure no trends in the data of increased risk.
The data will only be used by the research team within the VA to address the research questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right slow prefrontal rTMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation |
| Right fast prefrontal rTMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female veteran outpatients aged 18-50 years old
- Meet DSM-IV criteria for PTSD as determined by clinical interview and CAPS for DSM-5
- A PTSD checklist - (PCL) ≥ 45 at Screening/Baseline
- On stable medication and/or psychotherapy for 1 month and clinically appropriate to maintain for duration of trial
- Clinically competent to give informed written consent
Key exclusion criteria (15 listed)
- Veterans currently enrolled in an acute treatment of PTSD using evidence based psychotherapy including Prolonged Exposure Therapy (PE), Cognitive Processing Therapy (CPT), or Eye Movement Desensitization and Reprocessing (EMDR)
- History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident, metal in the skull, a history of major head trauma defined as greater than mild TBI, or any neurologic condition likely to increase risk of rTMS.
- Suicidal risk that precludes safe participation defined as clinical impression that the subject is at significant risk for suicide.
- Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder, bipolar disorder type I or II, dementia, dissociative disorders, or sexual and gender identity disorder
- Personality disorder that makes participation in the trial difficult
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: NeuroStar chair (Neuronetics, Malvern, PA)TMS Device | Device | Right fast prefrontal rTMS, Right slow prefrontal rTMS |
Primary outcome
Change Clinical-Administered Post Traumatic - DSM-5
Time frame: Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.
Change in IPF: Inventory of Psychosocial Functioning
Time frame: Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Change Inventory of Psychosocial Functioning (IPF) Administered at baseline and after 30 rTMS treatments. The IPF is an 80 question self-report scale that assessed function in the areas of family, work,friendships and socializing, parenting, education, self-care, and romantic relationships with spouse or partner. The rate is based on how often participant acted over the past 30 days. Domains are averaged with resulting score range 1 - 7. 1 Never - 7 Always.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30641346Kozel FA, Van Trees K, Larson V, Phillips S, Hashimie J, Gadbois B, Johnson S, Gallinati J, Barrett B, Toyinbo P, Weisman M, Centorino M, Gibson CA, Catalano G. One hertz versus ten hertz repetitive TMS treatment of PTSD: A randomized clinical trial. Psychiatry Res. 2019 Mar;273:153-162. doi: 10.1016/j.psychres.2019.01.004. Epub 2019 Jan 3.
- Individual participant dataSharing planned: No
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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.
F. Andrew Kozel, MD, MSCR. principal investigator
James A. Haley VAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Posttraumatic Stress Disorder and Depression, run by James A. Haley Veterans Administration Hospital at 1 site in United States.
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 5 inclusion and 15 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 27 Apr 2020. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Clinical-Administered Post Traumatic - DSM-5 (time frame: Baseline and after 30 rTMS Treatments (approximately 6 weeks)). The study lists 2 primary outcomes in all. 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 NCT02158663, 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 27 Apr 2020.