Reclaim™ Deep Brain Stimulation (DBS) Therapy for Obsessive-Compulsive Disorder (OCD)
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/21/2018 |
| Start Date: | November 2018 |
| End Date: | April 2020 |
| Contact: | Albert Fenoy, MD |
| Email: | Albert.J.Fenoy@uth.tmc.edu |
| Phone: | 713-704-7100 |
There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive
behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the
alternative approach or a combination of the two. A rarely used third therapy approach,
appropriate for only the most severely afflicted and treatment resistant patients, is
neurosurgical ablation of certain brain regions involved in mood and anxiety. The
neurosurgical ablation procedures are irreversible in nature, and involve the destruction of
specific volumes of brain tissue through various controlled means.
Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a
combination of the first two procedures and capsulotomy. DBS therapy is an alternative to
neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic,
severe OCD which has proven resistant to primary pharmacological and/or behavior therapy
options.
Results from 26 severe, treatment-resistant OCD patients treated with DBS at four
collaborating centers, three in the US, and one in Europe are summarized in great detail in
pages 12-22 of the provided/attached "Reclaim Summary of Safety and Probable Benefit."
behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the
alternative approach or a combination of the two. A rarely used third therapy approach,
appropriate for only the most severely afflicted and treatment resistant patients, is
neurosurgical ablation of certain brain regions involved in mood and anxiety. The
neurosurgical ablation procedures are irreversible in nature, and involve the destruction of
specific volumes of brain tissue through various controlled means.
Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a
combination of the first two procedures and capsulotomy. DBS therapy is an alternative to
neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic,
severe OCD which has proven resistant to primary pharmacological and/or behavior therapy
options.
Results from 26 severe, treatment-resistant OCD patients treated with DBS at four
collaborating centers, three in the US, and one in Europe are summarized in great detail in
pages 12-22 of the provided/attached "Reclaim Summary of Safety and Probable Benefit."
Procedure The DBS lead is stereotactically introduced into the target in the brain (AIC) and
fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously
in the subclavicular region. This is performed by a neurosurgeon skilled in this technique,
as the same procedure is routinely performed in patients with other diseases (using other
brain targets).
Sample Size:
There is no minimum number or maximum, but is expected to be far less than 100. Patients that
meet the inclusion criteria and will obtain insurance coverage will be candidates for the
procedure. As this is not a study on efficacy, there is no statistical analysis to be
performed. IRB approval is required per FDA stipulations. Recruitment: Patients who have
medically refractory OCD for at least 5 years or more, have failed 3 or more SSRIs, and who
meet the criteria for the indications above and are not contraindicated, will attempt to be
recruited, or to at least learn more information about the procedure, through the use of
flyers. These flyers will attempt to catch the attention of those subjects who may be
candidates, and who may benefit from the procedure; only through a more detailed clinic visit
would it be know if they meet criteria. The flyers are included as an attachment, and display
contact information. They will be posted on line, on free advertising bulletin boards, on UT
Psychiatry Clinic buildings, on Baylor Psychiatry Clinic buildings, within the UT and Baylor
schools of Medicine, and in private OCD support groups.
Course of Study Patients who are enrolled will meet the necessary requirements/indications
for insurance coverage of the system to be implanted.
Aside from these criteria, no specific population will be targeted or else excluded from
recruitment. They will sign the informed consent form (attached) prior to surgery if they
agree with the course of action. They will be followed for clinical effect and side effects
on a routine basis following surgery: after 2 weeks, 1, 2, 3, 4, 6 months and then every 6
months for months, by both the psychiatrist and neurosurgeon. The known risks are detailed in
the attached Summary of Safety and Probable Benefit document, Section VIII, as well as the
Device manual (attached). All patients enrolled will have their identity safe-guarded, will
be issued subject numbers, and personal information will be kept electronically under lock
and key in a permanent office.
Data Safety Monitoring As this procedure is nearly identical to that routinely performed here
on patients with Parkinson's disease (except that these are different patients and thus a
different brain structure is targeted), no specific/independent DSMB will be needed, as there
is none currently in use nor needed for the Parkinson's patients. Risks to
Clinicians/Researchers There are no known procedures or situations that will provide risks to
the clinical/research staff.
fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously
in the subclavicular region. This is performed by a neurosurgeon skilled in this technique,
as the same procedure is routinely performed in patients with other diseases (using other
brain targets).
Sample Size:
There is no minimum number or maximum, but is expected to be far less than 100. Patients that
meet the inclusion criteria and will obtain insurance coverage will be candidates for the
procedure. As this is not a study on efficacy, there is no statistical analysis to be
performed. IRB approval is required per FDA stipulations. Recruitment: Patients who have
medically refractory OCD for at least 5 years or more, have failed 3 or more SSRIs, and who
meet the criteria for the indications above and are not contraindicated, will attempt to be
recruited, or to at least learn more information about the procedure, through the use of
flyers. These flyers will attempt to catch the attention of those subjects who may be
candidates, and who may benefit from the procedure; only through a more detailed clinic visit
would it be know if they meet criteria. The flyers are included as an attachment, and display
contact information. They will be posted on line, on free advertising bulletin boards, on UT
Psychiatry Clinic buildings, on Baylor Psychiatry Clinic buildings, within the UT and Baylor
schools of Medicine, and in private OCD support groups.
Course of Study Patients who are enrolled will meet the necessary requirements/indications
for insurance coverage of the system to be implanted.
Aside from these criteria, no specific population will be targeted or else excluded from
recruitment. They will sign the informed consent form (attached) prior to surgery if they
agree with the course of action. They will be followed for clinical effect and side effects
on a routine basis following surgery: after 2 weeks, 1, 2, 3, 4, 6 months and then every 6
months for months, by both the psychiatrist and neurosurgeon. The known risks are detailed in
the attached Summary of Safety and Probable Benefit document, Section VIII, as well as the
Device manual (attached). All patients enrolled will have their identity safe-guarded, will
be issued subject numbers, and personal information will be kept electronically under lock
and key in a permanent office.
Data Safety Monitoring As this procedure is nearly identical to that routinely performed here
on patients with Parkinson's disease (except that these are different patients and thus a
different brain structure is targeted), no specific/independent DSMB will be needed, as there
is none currently in use nor needed for the Parkinson's patients. Risks to
Clinicians/Researchers There are no known procedures or situations that will provide risks to
the clinical/research staff.
Inclusion Criteria:
- have a diagnosis of OCD with a documented duration of at least 5 years;
- have OCD rated as severe or extreme illness;
- have comorbid depression and anxiety;
- have failed to improve following treatment with at least 3 selective serotonin
reuptake inhibitors (SSRIs)
- have completed or tried to complete Cognitive Behavior Therapy (CBT);
- have no serious psychiatric disorder in addition to OCD (e.g. comorbid personality
disorder) or substance abuse issues;
- meet established criteria for implantation of a deep brain stimulation system; are 18
years old or older;
Exclusion Criteria:
- hoarding as their primary subclassification;
- have had a previous surgery to destroy the region of the brain that will be the target
of stimulation;
- are pregnant;
- have any neurological disorders, including dementia;
- have a bleeding disorder or are not taking blood thinners;
- require routine MRIs.
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