Transcranial Magnetic Stimulation is a method by which very powerful magnets are used to stimulate areas of the brain that are underactive, or calm down areas of the brain that are overactive. Treatment must be administered by a trained physician. It is an FDA-approved method for the treatment of depression, and has been used as a research treatment for Post Traumatic Stress Disorder. In this study, we are comparing two different magnetic frequencies to see which is the most effective for treating PSTD. It is unclear the extent, if any, to which the treatment will help PTSD, so we are also tracking how much people improve by just waiting to get the treatment.
Individuals with who have been diagnosed with PTSD, and who are eligible for treatment at Naval Medical Center San Diego. PTSD can be from any cause. You must be screened for certain medical conditions that could make it unsafe for you to receive magnetic treatment. You must be willing and able to maintain your current, regular treatment for PTSD, without making changes during the two-week course of treatment.
How will I be assessed for treatment? You will first be called to go over some basic screening questions. If you seem like a good candidate for the study, we will set up a formal assessment with you. This assessment in our clinic lasts about 4 hours. It involves filling out some paper and pencil questionnaires, answering questions about your trauma and your symptoms. After the assessment you will meet with a doctor who will review the results with you and answer other questions about treatment. This assessment is used to confirm that you have PTSD that we think can be helped by the treatment. It will also look for other conditions that we should also address apart from the research treatment, and measure the severity of your symptoms so that we can tell if the treatment works for you.
If you decide to take part in this study, you will have a screening visit to see if you qualify. If you qualify and wish to continue, you will be randomly assigned (by chance) to 1 of 3 study groups:
1)You will receive 10 daily treatments of transcranial magnetic stimulation applied to target your brain near the right side of your head, a few inches above your ear, at 20 Hz.
Or
2)You will receive 10 daily treatments of transcranial magnetic stimulation applied to target your brain near the right side of your head, a few inches above your ear, at 10 Hz.
Or
3)You will continue to receive the same treatment you have been receiving, but you will be a wait list to receive one of the above treatments.
Treatment takes about 30 min to an hour each day, and is done five days a week for two weeks. It involves sitting in what looks like a dentist’s chair, while a very loud magnet makes a clicking sound next to your head. You will be assessed throughout treatment to see if the treatment is working for you, and will contacted periodically after treatment to see if the effect lasted.
Yes. We ask that you not substantially change your treatment over the course of the TMS treatment.
As with any medical treatment, there are risks. If you are interested in the study we will go over these with you in much greater detail. The machine used to perform transcranial magnetic stimulation is very loud. This can potentially cause hearing problems if proper hearing protection is not used. You will be provided with hearing protection during treatment. The most common adverse events reported with the use of transcranial magnetic stimulation are pain at the site of application, and headache. In general, application site pain and headache are transient and dissipated rapidly with time. Generalized seizures have been reported with the use of transcranial magnetic stimulation in the clinical trial literature. No seizures have been reported with use of the particular transcranial magnetic stimulation machine used in this study. The estimated risk of seizure under ordinary clinical use is approximately 1 in 30,000 treatments
If your PTSD symptoms are not resolved we will refer you into a different type of treatment.
Treatment is free, and likewise no payment is offered to participants.
Participation is entirely voluntary, and you may leave treatment at any time. If you desire, we will refer you to a different type of treatment.
What is the experimental part of the study? Transcranial magnetic stimulation has previously been shown to improve symptoms of PTSD in some studies. However, it is not FDA approved to treat this condition. Also, two different ways of applying the treatment are being compared, each stimulating at different frequencies. Both of these stimulating frequencies have been formally tested using transcranial magnetic simulation in the past
Manufacturer’s web page (mostly about treatment for depression, but includes a lot of good info)
From Medscape.com about TMS for PTSD
Research article about TMS for PTSD
Another research article about TMS for PTSD
To participate in the program, please e-mail Robert.McLay {at} med.navy.mil
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