A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
LFMS in PTSD
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedApril 13, 2016
April 1, 2016
2 years
August 6, 2015
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Improvement in core PTSD symptoms
1 week
Daily improvements in short-term measures of depression
24 hrs
Daily improvements in short-term measures of anxiety
24 hrs
Study Arms (2)
Active LFMS treatment
EXPERIMENTAL20 minutes of active Low Field Magnetic Stimulation using the LFMS device.
Sham LFMS treatment
SHAM COMPARATOR20 minutes of sham Low Field Magnetic Stimulation using the LFMS device.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Related Publications (2)
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.
PMID: 14702256BACKGROUNDRohan 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.
PMID: 24331545RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L Rohan, PhD
Mclean Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Imaging Physicist
Study Record Dates
First Submitted
August 6, 2015
First Posted
September 9, 2015
Study Start
September 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2019
Last Updated
April 13, 2016
Record last verified: 2016-04