A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
Status unconfirmed · Phase 1 · Has a placebo group
Conditions studied: Post Traumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT02545192
- Run by
- Mclean Hospital
- People needed
- 24
- Starts
- 2016-09-01
- Expected to finish
- 2019-09-01
- Last updated by the study team
- 2016-04-13
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- McLean Hospital — Belmont, Massachusetts, United States
Full record on ClinicalTrials.gov
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