Stress Disorders, Post-TraumaticNCT02268084
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
A study testing Magnetic EEG/ECG-guided Resonance Therapy in people with Stress Disorders, Post-Traumatic, run by Wave Neuroscience at 1 site in United States.
Trial summary
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Magnetic EEG/ECG-guided Resonance Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to adhere to the treatment schedule and all required study visits.
- Any non-Active Duty Military are included.
- PCL-M > 45
- Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS)
Who cannot join
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): History of open skull traumatic brain injury. History of clinically significant seizure disorder.
- Individuals with a clinically defined neurological disorder including, but not limited to: Any condition likely to be associated with increased intracranial pressure. Space occupying brain lesion. History of cerebrovascular accident. Cerebral aneurysm.
- EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the EEG recording.
- Any type of rTMS treatment within 3 months prior to the screening visit.
- Currently under antipsychotic medication treatment.
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
Show all 12Show fewer
- Clinically significant abnormality or clinically significant unstable medical condition that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results.
- Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
- Any condition which in the judgment of the investigator would prevent the subject from completion of the study.
- Inability to acquire a clinically satisfactory EEG/ECG on a routine basis.
- Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation.
- Active Duty Military are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Del Mar Center for Neurorestoration
San Diego, California, 92014
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
Read the detailed description
This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be treated in two phases: double-blind and open label.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Magnetic EEG/ECG-guided Resonance Therapy, Sham
- Keywords
- PTSD, TMS, EEG
- 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.
Magnetic EEG/ECG-guided Resonance TherapyDevice
Also called Magnetic Resonant Therapy, Magnetic e-Resonance Therapy, MeRT, MRT
A coil delivers a pulsed magnetic field to the cortex of the brain
ShamDevice
Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase only) using a sham device. Sham device mimics the same noise and sensation of active treatment. Receives: Device: Sham |
| Active sTMS | Active comparator | Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase) and 2 additional weeks for all subjects (open label) with Synchronized Transcranial Magnetic Stimulation (sTMS), using an active device. Receives: Device: Magnetic EEG/ECG-guided Resonance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase
Mean change in the PCL-M total scores of subjects from baseline to end of the double-blind treatment phase, compared between active and sham groups.
The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).
Measured: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Secondary outcomes (7)
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase
Mean change in the PCL-M total scores of subjects from baseline to end of the open-label treatment phase, compared between active and sham groups.
The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).
Measured: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment
Mean change in the PSQI-A total scores from baseline to end of the double-blind treatment, compared between active and sham groups.
The Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) is a 7-item metric to rate sleep disturbance items that are commonly reported with PTSD. Total scores range from 0 (least severe) to 21 (most severe), where scores greater than or equal to 4 have been used to identify adults with PTSD.
Measured: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment
Mean change is the PSQI-A total scores from baseline to end of the open-label treatment, compared between active and sham groups.
The Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) is a 7-item metric to rate sleep disturbance items that are commonly reported with PTSD. Total scores ranges from 0 (least severe) to 21 (most severe), where scores greater than or equal to 4 have been used to identify adults with PTSD.
Measured: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment
Mean change in the HAMD-17 total scores from baseline to end of double-blind treatment, compared between active and sham
The Hamilton Depression Rating Scale (HAMD-17) is a 17-item metric to rate subjects on severity of depressive symptoms. Total scores range from 0-52, with higher scores indicating more severe symptoms; a score of 0-7 is generally accepted to be within normal range (or in remission), while a score of 20 or greater indicates moderate to severe depression.
Measured: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment
Mean change in the HAMD-17 total scores from baseline to end of open-label treatment, compared between active and sham groups.
The Hamilton Depression Rating Scale (HAMD-17) is a 17-item metric to rate subjects on severity of depressive symptoms. Total scores range from 0-52, with higher scores indicating more severe symptoms; a score of 0-7 is generally accepted to be within normal range (or in remission), while a score of 20 or greater indicates moderate to severe depression.
Measured: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment
Mean change in each WHO-QOL domain score from baseline to end of treatment, compared between active and sham groups.
The World Health Organization's Quality of Life Index - BREF Version (WHO-QOL) is a metric used to establish the subject's quality of life in four domains: physical health (D1), psychological health (D2), social relationships (D3), and environmental health (D4). Higher scores indicate a more positive quality of life; D1 has a score range of 7-35, D2 has a range of 6-30, D3 has a range of 3-15, D4 has a range of 8-40.
Measured: Baseline and End of Double-Blind (Week 2)
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment
Mean change in each WHO-QOL domain score from baseline to end of open-label treatment, compared between active and sham groups.
The World Health Organization's Quality of Life Index - BREF Version (WHO-QOL) is a metric used to establish the subject's quality of life in four domains: physical health (D1), psychological health (D2), social relationships (D3), and environmental health (D4). Higher scores indicate a more positive quality of life; D1 has a score range of 7-35, D2 has a range of 6-30, D3 has a range of 3-15, D4 has a range of 8-40.
Measured: Baseline (Day 0) and End of Open-Label (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
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.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Model description
- Sham controlled
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wave Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Tahgva, MD, Principal investigator, 8583607260
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268084
- Sponsor's protocol ID
- MRT-002
- Status last verified
- Sep 2021
- First submitted
- 15 Oct 2014
- Last updated
- 1 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).
- ClinicalTrials.gov ID
- NCT02268084
- Acronym / sponsor ID
- MRT-002
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, TMS, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Wave NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 1 Oct 2021
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 this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
Detailed description
This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be treated in two phases: double-blind and open label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Sham controlled
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: ShamSham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase only) using a sham device. Sham device mimics the same noise and sensation of active treatment. |
| Active sTMS | Active comparator | Device: Magnetic EEG/ECG-guided Resonance TherapyActive treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase) and 2 additional weeks for all subjects (open label) with Synchronized Transcranial Magnetic Stimulation (sTMS), using an active device. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing and able to adhere to the treatment schedule and all required study visits.
- Any non-Active Duty Military are included.
- PCL-M > 45
- Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS)
Key exclusion criteria (12 listed)
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): History of open skull traumatic brain injury. History of clinically significant seizure disorder.
- Individuals with a clinically defined neurological disorder including, but not limited to: Any condition likely to be associated with increased intracranial pressure. Space occupying brain lesion. History of cerebrovascular accident. Cerebral aneurysm.
- EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the EEG recording.
- Any type of rTMS treatment within 3 months prior to the screening visit.
- Currently under antipsychotic medication treatment.
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 |
|---|---|---|
| Magnetic EEG/ECG-guided Resonance TherapyAlso: Magnetic Resonant Therapy, Magnetic e-Resonance Therapy, MeRT, MRTA coil delivers a pulsed magnetic field to the cortex of the brain | Device | Active sTMS |
| ShamSham coil simulates behavior of the intervention magnetic coil without applying the magnetic field | Device | Sham Stimulation |
Primary outcome
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase
Time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean change in the PCL-M total scores of subjects from baseline to end of the double-blind treatment phase, compared between active and sham groups. The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).
7 secondary outcomes
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase
Time frame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment
Time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment
Time frame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment
Time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment
Time frame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment
Time frame: Baseline and End of Double-Blind (Week 2)
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment
Time frame: Baseline (Day 0) and End of Open-Label (Week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alex Tahgva, MD principal investigator
8583607260
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic EEG/ECG-guided Resonance Therapy in people with Stress Disorders, Post-Traumatic, run by Wave Neuroscience 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 4 inclusion and 12 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 1 Oct 2021. 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. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2021). 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?
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase (time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2021.