Clinical trial NCT02545192: A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
Official title: A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects will be men or women between the ages of 21-65.
2. Subjects will meet Diagnostics and Statistical Manual of Mental Disorders (DSM-IV) criteria for Post Traumatic Stress Disorder (PTSD), current.
3. Subject must have a PTSD Check List-5 (PCL-5) score greater than 38.
4. Subjects must be capable of providing informed consent.
5. Subjects must have an established residence and phone.
6. Subjects may be medicated or unmedicated.

Exclusion Criteria:

1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. 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).
4. Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
5. Subjects must not have serious physical illnesses, neurological diseases or dementias.
6. Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
7. History of an Axis 2 disorder, schizophrenia or schizoaffective disorder.
8. Contraindications for magnetic resonance imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.

Primary outcomes:
measure: Change in depression
timeFrame: 1 week
measure: Change in anxiety
timeFrame: 1 week
Secondary outcomes:
measure: Improvement in core PTSD symptoms
timeFrame: 1 week
measure: Daily improvements in short-term measures of depression
timeFrame: 24 hrs
measure: Daily improvements in short-term measures of anxiety
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Michael L Rohan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.