Post Traumatic Stress DisorderPhase 1LFMS in PTSDNCT02545192
A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
A Phase 1 study testing Low Field Magnetic Stimulation in people with Post Traumatic Stress Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
The investigators propose to make the first observations of LFMS treating a population of subjects with PTSD. A positive outcome for this study could translate directly into a new treatment modality for symptoms of PTSD in both acute and chronic situations. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Low Field Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2019
- Phase
- Phase 1
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be men or women between the ages of 21-65.
- Subjects will meet Diagnostics and Statistical Manual of Mental Disorders (DSM-IV) criteria for Post Traumatic Stress Disorder (PTSD), current.
- Subject must have a PTSD Check List-5 (PCL-5) score greater than 38.
- Subjects must be capable of providing informed consent.
- Subjects must have an established residence and phone.
- Subjects may be medicated or unmedicated.
Who cannot join
- Dangerous or active suicidal ideation.
- Pregnant or planning on becoming pregnant.
- Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
- Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
- Subjects must not have serious physical illnesses, neurological diseases or dementias.
- Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
- History of an Axis 2 disorder, schizophrenia or schizoaffective disorder.
- Contraindications for magnetic resonance imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to make the first observations of LFMS treating a population of subjects with PTSD. A positive outcome for this study could translate directly into a new treatment modality for symptoms of PTSD in both acute and chronic situations. The investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in the treatment of PTSD.
Read the detailed description
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. LFMS electromagnetic fields are significantly weaker than those occurring in electroconvulsive therapy (ECT) and repeated transcranial magnetic stimulation (rTMS).
LFMS was discovered at McLean Hospital and has been studied as an experimental antidepressant treatment at McLean. Results from the investigator's single-visit protocol (2006-P-001655) are encouraging, and demonstrate an immediate mood improvement from LFMS in depressed subjects. This indicates that LFMS continues to show potential as a treatment for depression. The profile of clinical response to LFMS that was observed in that study included improvement in symptoms of anxiety. In this current proposal the investigator's will study the effects of LFMS on these symptoms of depression and anxiety that are present in a population with a primary diagnosis of PTSD. The proposed protocol involves three treatments on consecutive days with follow-up ratings one week after the first treatment and follow-up by phone ratings in weeks three and four after the first treatment.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Low Field Magnetic Stimulation
- 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.
Low Field Magnetic StimulationDevice
Also called LFMS
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1000Hz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. A fully detailed description of the electromagnetic field distribution and waveform has been presented in the IDE submission to the FDA (and determined to be a non-significant risk device).
| Study group | Role | What they receive |
|---|---|---|
| Active LFMS treatment | Experimental | 20 minutes of active Low Field Magnetic Stimulation using the LFMS device. Receives: Device: Low Field Magnetic Stimulation |
| Sham LFMS treatment | Sham comparator | 20 minutes of sham Low Field Magnetic Stimulation using the LFMS device. Receives: Device: Low Field Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Change in depression as measured by the Montgomery Asberg Depression Rating Scale in subjects receiving active LFMS treatment relative to sham treatment
Measured: 1 week
Change in anxiety
Change in anxiety levels as measured by the Hamilton Anxiety Rating Scale in subjects receiving active LFMS treatment relative to sham treatment
Measured: 1 week
Secondary outcomes (3)
Improvement in core PTSD symptoms
Measures of core PTSD symptoms will show improvement over one week in subjects receiving active LFMS treatment relative to sham treatment
Measured: 1 week
Daily improvements in short-term measures of depression
Short term measures of depression will show improvements in subjects receiving active LFMS treatment relative to sham treatment
Measured: 24 hrs
Daily improvements in short-term measures of anxiety
Short term measures of anxiety will show improvements in subjects receiving active LFMS treatment relative to sham treatment
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rohan, Mclean Hospital
- Investigators
- Michael L Rohan, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545192
- Sponsor's protocol ID
- 2015P001621
- Acronym
- LFMS in PTSD
- Status last verified
- Apr 2016
- First submitted
- 6 Aug 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
PubMed 14702256Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.
PubMed 24331545
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
- ClinicalTrials.gov ID
- NCT02545192
- Acronym / sponsor ID
- LFMS in PTSD / 2015P001621
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 9 Sep 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 investigators propose to make the first observations of LFMS treating a population of subjects with PTSD. A positive outcome for this study could translate directly into a new treatment modality for symptoms of PTSD in both acute and chronic situations. The investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in the treatment of PTSD.
Detailed description
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. LFMS electromagnetic fields are significantly weaker than those occurring in electroconvulsive therapy (ECT) and repeated transcranial magnetic stimulation (rTMS).
LFMS was discovered at McLean Hospital and has been studied as an experimental antidepressant treatment at McLean. Results from the investigator's single-visit protocol (2006-P-001655) are encouraging, and demonstrate an immediate mood improvement from LFMS in depressed subjects. This indicates that LFMS continues to show potential as a treatment for depression. The profile of clinical response to LFMS that was observed in that study included improvement in symptoms of anxiety. In this current proposal the investigator's will study the effects of LFMS on these symptoms of depression and anxiety that are present in a population with a primary diagnosis of PTSD. The proposed protocol involves three treatments on consecutive days with follow-up ratings one week after the first treatment and follow-up by phone ratings in weeks three and four after the first treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active LFMS treatment | Experimental | Device: Low Field Magnetic Stimulation20 minutes of active Low Field Magnetic Stimulation using the LFMS device. |
| Sham LFMS treatment | Sham comparator | Device: Low Field Magnetic Stimulation20 minutes of sham Low Field Magnetic Stimulation using the LFMS device. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be men or women between the ages of 21-65.
- Subjects will meet Diagnostics and Statistical Manual of Mental Disorders (DSM-IV) criteria for Post Traumatic Stress Disorder (PTSD), current.
- Subject must have a PTSD Check List-5 (PCL-5) score greater than 38.
- Subjects must be capable of providing informed consent.
- Subjects must have an established residence and phone.
Key exclusion criteria (8 listed)
- Dangerous or active suicidal ideation.
- Pregnant or planning on becoming pregnant.
- Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
- Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
- Subjects must not have serious physical illnesses, neurological diseases or dementias.
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 |
|---|---|---|
| Low Field Magnetic StimulationAlso: LFMSThe LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1000Hz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. A fully detailed description of the electromagnetic field distribution and waveform has been presented in the IDE submission to the FDA (and determined to be a non-significant risk device). | Device | Active LFMS treatment, Sham LFMS treatment |
Primary outcome
Change in depression
Time frame: 1 week
Change in depression as measured by the Montgomery Asberg Depression Rating Scale in subjects receiving active LFMS treatment relative to sham treatment
Change in anxiety
Time frame: 1 week
Change in anxiety levels as measured by the Hamilton Anxiety Rating Scale in subjects receiving active LFMS treatment relative to sham treatment
3 secondary outcomes
Improvement in core PTSD symptoms
Time frame: 1 week
Daily improvements in short-term measures of depression
Time frame: 24 hrs
Daily improvements in short-term measures of anxiety
Time frame: 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 14702256Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
- Results publication: PubMed 24331545Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.
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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.
Michael L Rohan, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Field Magnetic Stimulation in people with Post Traumatic Stress Disorder, run by Mclean 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Apr 2016. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael L Rohan, PhD (617-855-3127, mrohan@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: 1 week). 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 NCT02545192, which also lists 2 linked publications.
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 13 Apr 2016.