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A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments (LFMS in PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545192
Recruitment Status : Unknown
Verified April 2016 by Michael Rohan, Mclean Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2015
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Device: Low Field Magnetic Stimulation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active LFMS treatment
20 minutes of active Low Field Magnetic Stimulation using the LFMS device.
Device: Low Field Magnetic Stimulation
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 Name: LFMS

Sham Comparator: Sham LFMS treatment
20 minutes of sham Low Field Magnetic Stimulation using the LFMS device.
Device: Low Field Magnetic Stimulation
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 Name: LFMS




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Daily improvements in short-term measures of depression [ Time Frame: 24 hrs ]
    Short term measures of depression will show improvements in subjects receiving active LFMS treatment relative to sham treatment

  3. 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



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545192


Contacts
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Contact: Michael L Rohan, PhD 617-855-3127 mrohan@mclean.harvard.edu
Contact: LFMS Research Phone 617-855-4433 LFMS@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
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Principal Investigator: Michael L Rohan, PhD Mclean Hospital
Publications of Results:
Other Publications:
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Responsible Party: Michael Rohan, Imaging Physicist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02545192    
Other Study ID Numbers: 2015P001621
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Keywords provided by Michael Rohan, Mclean Hospital:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders