Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active LFMS treatment | Experimental | 20 minutes of active Low Field Magnetic Stimulation using the LFMS device. |
|
| Sham LFMS treatment | Sham Comparator | 20 minutes of sham Low Field Magnetic Stimulation using the LFMS device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Field Magnetic Stimulation | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week |
| Daily improvements in short-term measures of depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael L Rohan, PhD | Contact | 617-855-3127 | mrohan@mclean.harvard.edu | |
| LFMS Research Phone | Contact | 617-855-4433 | LFMS@mclean.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael L Rohan, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14702256 | Background | 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. | |
| 24331545 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Short term measures of depression will show improvements in subjects receiving active LFMS treatment relative to sham treatment
| 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 | 24 hrs |