Clinical Trial Details
Braintumor Website

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NCT03184454 : Combined Cortical/Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder
PhasePhase 2
AgesMin: 21 Years Max: 64 Years
Inclusion Criteria:

1. OCD, diagnosed by Structured Clinical Interview for DSM-5 (SCID-5), judged of
disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at
least 28.

2. Persistence of severe symptoms and impairment for five or more years despite: i. at
least three adequate (=3 months at the maximum tolerated dose) serotonin transporter
inhibitor trials (may use any serotonin or serotonin-norepinephrine inhibitors, but
must include a trial of clomipramine) alone or in combination with ii. adequate
behavior therapy (=20 sessions of expert exposure and response prevention; At least 20
sessions of behavioral therapy must be attempted), and iii. augmentation of one of the
selective SRIs with a neuroleptic or clonazepam.

3. Age between 21 and 64 years.

4. Able to understand and comply with instructions.

5. Able to give fully informed, written consent in the judgment of the site Consent

6. Either drug free or on a stable drug regimen for at least 6 weeks.

7. Good general health.

8. A family member or significant other, in contact with the patient every 1-3 days, is
available and willing to communicate with the research team if the patient's clinical
status worsens, and if necessary to accompany patients to study visits.

9. The local referring psychiatrist is willing to provide ongoing care during and after
the trial.

10. Patient is aware of, able to adhere to, and willing to tolerate the frequency of
visits associated with adjustment of the dual-stimulation configuration and/or
collection of brain recordings. This will usually mean limitation to patients who live
close to the study site.

11. Platelet count greater than 125,000 per cubic millimeter and a PT and PTT within
normal limits.

Exclusion Criteria:

1. Current or past psychotic disorder.

2. Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) 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 the site psychiatrist. A questionnaire assessing consent
comprehension will be used with all study subjects, to ensure that they understand the
key procedures of the study, and its risks and benefits. An independent monitor will
administer that questionnaire.

3. A clinical history of bipolar mood disorder. We will not exclude substance-induced
mania or hypomania.

In our prior studies, a history of induced hypomanic symptoms did not predict
DBS-related hypomania.

4. Any current clinically significant neurological disorder or medical illness affecting
brain function, other than tic disorders or Tourette syndrome.

5. Any clinically significant abnormality on preoperative magnetic resonance imaging

6. 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.

7. Current or unstably remitted substance abuse, dependence, or a positive urine
toxicology screen.

8. Pregnancy and women of childbearing age not using effective contraception.

9. Unable to adhere to operational and administrative study requirements (in the
investigators' judgment).

10. Clinical history of severe personality disorder.

11. Imminent risk of suicide or an inability to control suicide attempts (in the
investigators' judgment).

History of serious suicidal behavior or one or more interrupted suicide attempts with
potential lethality judged to result in serious injury or death.

12. Diagnosis of body dysmorphic or hoarding disorder.

13. Evidence of dementia or other significant cognitive impairment on neuropsychological
evaluation or through cognitive screening (MOCA).
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