OCD is a mental health disorder characterized by unreasonable thoughts and fears (obsessions) which may lead to repetitive behaviors ( compulsions). OCD can severely affect one’s daily life and routines and cause distress and functional impairment. Although psychiatric medications and psychotherapy interventions are available, some OCD patients experience limited results from these and need more therapeutic options.
MagVenture TMS Therapy as an adjunct therapy for OCD uses short magnetic pulses to target the exact areas in the brain that are affected by OCD. The magnetic coil that delivers the TMS treatment is placed on top of the head as shown on the picture above. Clinical studies have demonstrated that rTMS over this part of brain, the prefrontal cortex, is safe and effective for the adjunct treatment of OCD.
510(k) evidence of MagVenture TMS Therapy system – for adjunctive treatment of OCD
The present 510(k) does not include new pivotal data, but includes clinical trial data on more than 500 subjects treated with the MagVenture TMS Therapy System, in order to demonstrate performance and safety. Treatment of OCD is applied to the human brain of the bilateral dorsomedial prefrontal cortex (DMPFC) using 20 Hz TMS for 18 min. The treatment parameters are identical to those recommended by the Primary Predicate Device.
Literature demonstrates that the new device can be used effectively and routinely for determining Leg MT, and that the treatment modulates brain activity locally in the DMPFC and strongly suggests also distal brain areas, through downstream activation of long-range networks. Though MDD and OCD are two distinct psychiatric disorders, they share some common underlying deficits in brain networks. So, though most of the research using the new device has investigated treatment of MDD, the data can support the use of the new device as an adjunct for treatment of OCD in terms of safety and given that the treatments have been performed targeting the same cortical area, DMPFC bilaterally, in a substantially equivalent way to the primary predicate device.
Frequently asked Questions about TMS for OCD:
1. Am I a candidate for TMS?
MagVenture TMS Therapy is available by prescription only. Your doctor will use medication dosing records and questionnaires as well as other measures to determine whether or not you are a candidate for MagVenture TMS Therapy.
2. How long does it take?
A full treatment course lasts 6 weeks with one 18 minute MagVenture TMS Therapy session per day for 5 days (week 1-5) and one treatment session per day for 4 days (week 6). MagVenture TMS Therapy as adjunct OCD treatment means that other types of therapy, typically behavioral therapy and/or medication may also be included in your treatment plan. Just before each TMS session, your physician or TMS operator will provoke or trigger your OCD symptoms. Studies show that this procedure, which has been tailored individually, may improve your response to the TMS therapy.
3. What does TMS feel like?
You sit in a chair in a relaxed position. When the magnetic pulses are delivered you hear a clicking sound and feel a tapping sensation on your head. Many patients are able to watch television or read during treatment.
4. What is the likelihood that TMS will help improve my OCD?
Clinical studies report a 38% response rate for those receiving active treatment after completing the full 6 week treatment course1. For those who received sham (placebo), the response rate was 11%. A one-month follow-up showed 45% response in the active group and 18% in the sham group.
5. Are there any side effects to MagVenture TMS therapy?
TMS may, for some, cause headache or nausea and counter pain meds may therefore be taken prior to treatment, if needed. You should, however, be able to resume your daily activities right after treatment. Bear in mind that TMS Therapy is a medical procedure and any side effects experienced during or after receiving the therapy should be reported to your doctor.
