What are the differences between Deep Brain Stimulation and Gamma Knife Neurosurgery?
Deep Brain Stimulation (DBS) is reversible while Gamma Knife, like any lesion surgery, is not. With DBS, no significant amount of brain tissue is damaged, and the devices can be totally removed if the stimulation does not help.
However, because leads are implanted in the brain, the removal process still poses a degree of risk, and some scar tissue can remain in the areas of the brain where the leads were inserted. Another important difference is that you can still have the gamma knife procedure if DBS does not work but not the other way around.
Who can participate in the DBS for OCD Study?
To participate in this study a patient must meet all of the inclusion criteria and fail to meet any of the exclusion criteria.
The criteria for inclusion in this study are:
- OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30. In addition, impaired functioning indicated by a Global Assessment of Functioning (GAF) score of 45 or less.
- Highly treatment-refractory illness is documented. That is, there must be demonstration of persistence of severe symptoms and impairment for five or more years despite at least three first-line and two second-line treatments, as follows:
- Age between 18 and 65 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent in the judgment of the site Consent Monitor.
- Either drug free or on a stable drug regimen for at least six weeks.
- Good general health.
- It is also very helpful, though not an absolute requirement, to have a family member or significant other person who sees the patient regularly and can communicate with the study team as needed, and if necessary to accompany the patient to study visits.
- The patient's local referring psychiatrist is willing to provide ongoing care during and after the trial, working closely with the research team. The local psychiatrist must agree that the study psychiatrist will prescribe medications during the three-month masked phase.
- Has a platelet count greater than 125,000 per cubic millimeter and a PT and PTT within normal limits.
The criteria for exclusion from this study are:
- Current or past psychotic disorder.
- Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WASI), or cognitive impairment that would affect a participant’s ability to give informed consent or provide interview or self-report data reliably, as determined by the Consent Monitor and site psychiatrist.
- A clinical history of bipolar mood disorder.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
- Any labeled DBS contraindication, and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
- **Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
- Pregnancy and women of childbearing age not using effective contraception.
- Unable to adhere to operational and administrative study requirements (in the investigators’ judgment).
- Clinical history of severe personality disorder.
- An inability to control suicide attempts, immanent risk of suicide in the investigator’s judgment, or a history of serious suicidal behavior. This is defined, using the Columbia-Suicide Severity Rating Scale (C-SSRS), as: either 1) one or more actual suicide attempts in the preceding 3 years, the lethality of which is rated at 3 or higher or 2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
- Current diagnosis of body dysmorphic disorder.
**Note on exclusion criterion: The determination of whether a patient is stably remitted or of whether their substance abuse history is far enough in their past is made by the sites. However, sites are always welcome to raise any questions of eligibility with the study group as a whole. The IRG may or may not agree, and may decide to not approve the patient.
Is Deep Brain Stimulation approved by the FDA?
Deep Brain Stimulation is approved by the Food & Drug Administration for treatment of non-psychiatric illnesses, such as Parkinson’s disease and dystonia. The FDA has recently granted Humanitarian Device Exemption approval for the use of DBS in the treatment of OCD. This study is covered under an FDA Investigational Device Exemption.
What does the electrical stimulation feel like?
Most people do not feel the stimulation when the device is on, although some people have experienced a brief tingling sensation when stimulation is initiated.
I still have other questions. Where can I get more information?
Please direct further questions to Roberta McMahon at 401-455-6594 or email@example.com.
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