- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545192
A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments (LFMS in PTSD)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Michael L Rohan, PhD
- Phone Number: 617-855-3127
- Email: mrohan@mclean.harvard.edu
Study Contact Backup
- Name: LFMS Research Phone
- Phone Number: 617-855-4433
- Email: LFMS@mclean.harvard.edu
Study Locations
-
-
Massachusetts
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Belmont, Massachusetts, United States, 02478
- McLean Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active LFMS treatment
20 minutes of active Low Field Magnetic Stimulation using the LFMS device.
|
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).
Other Names:
|
Sham Comparator: Sham LFMS treatment
20 minutes of sham Low Field Magnetic Stimulation using the LFMS device.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week
|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in core PTSD symptoms
Time Frame: 1 week
|
Measures of core PTSD symptoms will show improvement over one week in subjects receiving active LFMS treatment relative to sham treatment
|
1 week
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Daily improvements in short-term measures of depression
Time Frame: 24 hrs
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Short term measures of depression will show improvements in subjects receiving active LFMS treatment relative to sham treatment
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24 hrs
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Daily improvements in short-term measures of anxiety
Time Frame: 24 hrs
|
Short term measures of anxiety will show improvements in subjects receiving active LFMS treatment relative to sham treatment
|
24 hrs
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael L Rohan, PhD, McLean Hospital
Publications and helpful links
General 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.
- Rohan 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P001621
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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