This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.
This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained. Following implantation of bilateral Medtronic Percept stimulating and recording electrodes in the ACB with electrode Medtronic 3391 and of bilateral Medtronic 3387 electrodes in participants, they will be entered into a two week baseline period with baseline clinical assessments(see Schedule of Assessments) and imaging. Patients will be randomized into ACB or vALIC arms of the study and enter a two week period of stimulation optimization followed by 12 weeks of active blinded treatment in the first condition and then crossed over to the alternate condition where following discontinuation of the first condition stimulation an additional two week period of stimulation optimization in the alternate condition will be followed by an additional twelve weeks of stimulation in the alternate condition. Primary outcome measures will include the YBOCs-II and the Clinical Global Assessment. Ratings will be obtained by independent raters blind to stimulation condition. Following the completion of the second 12 week blinded period, the patient will enter an open nonblinded study of ACB plus vALIC stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
Surgical implantation of deep brain stimulation electrodes with stimulation at one of two intracranial targets depending on randomization and crossover status.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of the both targets.
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.