Project STIM for OCD - Phase 3 Changing Brain Function Through Stimulation
Primary Principal InvestigatorBenjamin Greenberg
If you have been diagnosed with obsessive-compulsive disorder (OCD), you may be interested in participating in Project STIM, a research study testing how TMS may change brain activity and symptoms in people with OCD.
Obsessive-compulsive disorder (OCD) is often treated with a combination of medications and psychotherapies. Increasing evidence suggests that transcranial magnetic stimulation (TMS), a noninvasive brain stimulation technique, might also be helpful. In the next phase of Project STIM for OCD, we will test how a new form of TMS, called continuous theta burst stimulation, changes brain function and symptoms in people with OCD.
Why should I join the study? Project STIM tests whether continuous theta burst TMS, a treatment which can be delivered in a very short time (the actual stimulation takes less than a minute), holds promise as an OCD treatment. We determine this by looking for changes in patterns of brain activity on MRI scans before and after 10 weekday TMS sessions, and by interviews and questionnaires to see if symptoms have changed. This is an "open-label" study, which means all participants get the actual TMS treatment. There is no sham or placebo group. The risk involved for those participating is quite low. The risk involved for those participating is quite low.
What will happen if I join the study? First the research team will determine if the study is a good fit for you, using questionnaires and interviews. Then an initial MRI scan is scheduled, followed by 10 very brief weekday TMS sessions, most sessions will last about 15-20 minutes in total, except for the first stimulation day which takes longer as the placement of the TMS coil (which delivers the treatment) needs to be individually determined using your first MRI and special computer software. The second and last MRI is scheduled after the 10 TMS sessions. There are also three follow-up appointments, after the 10 TMS sessions, and again one and then three months later to monitor OCD symptoms, ability to function in daily life, and other changes you might experience.
How long will the research last? The study takes three to six weeks to complete screening, the first MRI, the 10 sessions of TMS (daily Monday through Friday for two weeks), the second MRI, and a follow-up visit. All procedures happen on the Butler Hospital campus except the two MRI scans that happen at Brown University. The main part of the study takes about three weeks after the initial baseline visit, though there are brief visits one month and three months after completing TMS.
Using technology to change the brain’s functionality in OCD patients
What technology is used for transcranial magnetic stimulation (TMS)?This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a figure-eight shaped coil placed on your scalp. It is often said that this feels like a tapping sensation on the head, but it is very brief, lasting about forty seconds.
Who is eligible? The study is open to 18 to 70 year old individuals who meet the following criteria:
- Ability to speak, read, write and understand English sufficiently to complete study procedures and provide informed consent.
- Have a current diagnosis of clinically significant OCD.
- Taking prescribed medications at stable doses for at least four to six weeks; or not currently taking any medication.
- If currently participating in ongoing psychotherapy, have completed at least three months of treatment before entering the study.
- Be able to undergo an MRI scan, a procedure which excludes those who are pregnant, claustrophobic, or have a history of metal fragments or metal objects in the body.
Will I be paid? You will be compensated up to $310 for your time. Payment for participation is based on attendance of screening visit(s), 10 TMS sessions, pre- and post-TMS MRI scans, and follow-up appointments.
Obsessive Compulsive Disorder (OCD)