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Deep Brain Stimulation in Obsessive Compulsive Disorder

Table Summarizing Clinical Research Studies

Studies used in this table were either double-blinded crossover trials and/or prospective trials; no retrospective case series or reviews are included.

First Author (Year) Study Title Country
Funder(s)
Intervention  Tested  Study Size Inclusion Criteria,
Patient Demographics
Trial Type Findings

Investigational Brain Stimulation Target: Junction of Ventral Capsule and Ventral Striatum (VC/VS)

Greenberg
(2010)
Deep brain
stimulation
 of the
ventral internal
capsule/ventral
striatum
for obsessive-
compulsive
disorder:
worldwide
experience
United States
Belgium
---
• Brain & Behavior Research Foundation
• National Institute of Mental Health
• Medtronic Inc.
Condition after Bilateral VC/VS Stimulation
 vs
Condition before Implantation
26 • Adults (ages 22 - 59)
• Severe OCD for at least 5 years
• Failure of
at least 3
months of traditional pharmacological and behavioral therapy

• No previous
or current psychotic, personality, or neurologic disorders

• Not pregnant

Co-Morbid Conditions:
  
Major Depressive Disorder (22/26)

Prospective Cohort Study

Performed
with FDA Investigational  Device Exemption Approvals

Length:
31.4 ± 4.1 months
(17 with
>24
months)

• Significant improvement over first 3 months of stimulation with continued effect seen at 36 months (average of 38.5% improvement
• Over time, there is an increase in the percentage of patients receiving benefit (61.5% with at least a 35% improvement of their OCD score at 36 months)

• Improvement in concurrent depression (average of 43.2% improvement)
• Improvement in concurrent anxiety (average of 52.6% improvement)
• Improvement in overall daily function (average of 69.5% improvement)

Major Adverse Events:
   • Intracranial hemorrhage (2/26)
   • Worsening of depression (3/26)
Greenberg
(2006)
Three-year
outcomes in
deep brain
stimulation
for highly
resistant
obsessive-
compulsive
disorder
United States
---
• Brain & Behavior Research Foundation
• National Institute of Mental Health
• Medtronic Inc.
Condition after Bilateral VC/VS Stimulation
 vs
Condition before Implantation
8 • Adults (ages 22 - 59)
• Severe OCD for at least 11 years
• Failure of
at least 3
months of traditional pharmacological and behavioral therapy

• No previous
or current psychotic, personality,
or neurologic disorders

• Not pregnant

Co-Morbid Conditions:
  
Major Depressive Disorder (7/8)
Prospective Cohort Study

Performed
with FDA Investigational Device Exemption Approvals


Length:

≥ 36
months
• Significant improvement seen at 36 months (average of 35.5% improvement)
• 50% patients had at least a 35% improvement in their OCD score

• Improvement in concurrent depression (average of 27.0% improvement)
• Improvement in concurrent
anxiety (average of 56.0% improvement)
• Improvement in overall daily function (average of 32.0% improvement)

Major Adverse Events:
   • Intracranial hemorrhage (1/8)
   • Discontinued stimulation due to lack of adequate therapeutic effects (2/8)
Nuttin
(2003)
Long-term
electrical
capsular
stimulation
in patients
with obsessive-
compulsive
disorder
Belgium
---
• Fonds voor Wetenschappelijk Onderzoek-Vlaanderen
• Research Council of the Katholieke Universiteit Leuven
• Verkennende Internationale Samenwerking
• Medtronic Inc.
Condition with Bilateral VC/VS Stimulation
 vs
Condition without Stimulation
4 • Adults (ages 18 - 60)
• Disabling OCD for at least 5 years
• Failure of at least 2 traditional pharmacological agents and behavioral therapy
• No previous or current psychotic, personality, or neurologic disorders

Co-Morbid Conditions:
  
Major Depressive Disorder (2/4)
   Somatoform Disorder (1/4)
Double
Blinded

Crossover Study
followed
by a

Prospective Cohort
Study


(no mention
of ethical review)

Length:
21 months
(6 months blinded)

• Greater improvement with active stimulation
  (average OCD score 38.7% better)
• Condition similar to baseline when stimulation turned off
• 75% patients had at least a 35% improvement in their OCD score

• Greater improvement in depression with active stimulation
  (average score 41.8% better)
• Increased suicidal ideation noted when
stimulator turned off
• Imaging demonstated a decrease in frontal lobe activity with stimulation

Major Adverse Events:
   • Device removal due to ineffectiveness (1/4)
Tsai
(2002)
Pilot study
of deep brain
stimulation
in refractory
obsessive-
compulsive
disorder ethnic
Chinese
patients
Taiwan
---
• Buddhist Tzu-Chi Hospital
Condition with Bilateral VC/VS Stimulation
 vs
Condition before Implantation
4 • Adult males (ages 21 - 30)
• Severe OCD for at least 3 years
• Failure of multiple pharmacological trials and behavioral therapy
• No previous
or current psychotic, personality,
or neurologic disorders

• No substance abuse

Co-Morbid Conditions:
  
Major Depressive Disorder
(3/4)
Prospective Cohort Study

Approved by the Taiwan Department
of Health

Length:
15 months

• Significant improvement seen at 15 months (average of 33.06% improvement)
• 100% patients had at least a 30% improvement in their OCD score

• Improvement in concurrent depression (average of 32.51% improvement)
• Improvement in overall daily function (average of 31.03% improvement)

Major Adverse Events:
   • Allergic reaction (1/4)
   • Brief hypomania (2/4)

Investigational Brain Stimulation Target: Nucleus Accumbens (NAcc)

Huff
(2010)
Unilateral
deep brain
stimulation
of the nucleus
accumbens
in patients
with treatment-
resistant
obsessive-
compulsive
disorder:
Outcomes
after one year
Germany
---
• Cologne Fortune Program Grant
• Medtronic Inc.
Condition with Right-sided NAcc Stimulation
 vs
Condition without Stimulation
vs
Condition before Implantation
10 • Adults
(ages 21 - 65)

• Severe OCD for at least 5 years
• Failure of 4 pharmaceutical and behavioral therapy treatment regimens, each lasting at least 10 weeks
• No previous
or current psychotic, personality, or neurologic disorders

• No substance abuse
• Not pregnant

Co-Morbid Conditions:
  
Major Depressive Disorder (6/10)
Double
Blinded

Crossover Study
followed
by a

Prospective Cohort
Study


Approved
by the Institutional Ethics Committee
and in accordance with the Helsinki Declaration

Length:
15 months
(6 months blinded)

• Significant improvement seen at 12 months (average of 21.4%)
• Slightly greater improvement with active stimulation (average OCD score 10.3% better)
• 50% patients had at least a 25% improvement in their OCD score

• Improvement in concurrent depression (average of 30.0% improvement)
• Improvement in overall daily function (average of 45.1% improvement)

• No significant improvement in
anxiety or cognitive function

Major Adverse Events:
   • Dysesthesia (1/10)
Denys
(2010)
Deep brain
stimulation
of the nucleus
accumbens for
treatment-
refractory
obsessive-
compulsive
disorder
The Netherlands
---
• Netherlands Organization for
 Scientific Research
• Medtronic Inc.
Condition with Bilateral NAcc Stimulation
 vs
Condition without Stimulation
vs
Condition before Implantation
16 • Adults (ages 18 - 65)
• Disabling
OCD for
at least
5 years

• Failure of 4 pharmaceutical and behavioral therapy treatment regimens, each lasting at least 12 weeks
• No previous
or current psychotic, personality,
or neurologic disorders

• No substance abuse

Co-Morbid Conditions:
  
Major Depressive Disorder (6/16)

Prospective Cohort Study
with a
Double
Blinded

Crossover Segment

Registered
in the International Control Trial Registry and approved by the Institutional Medical
Ethics Review Committee

Length:
21 months
(1 month blinded
)
• Significant improvement seen at 8 months (average of 46% improvement)
• Persistent improvement seen at 21 months (average of 52% improvement)
• Greater improvement with active stimulation (average OCD score 25% better)
• 56.3% of patients had at least a 35% improvement in their OCD score

• Improvement in concurrent depression (average of 45.1% improvement)
• Improvement in concurrent anxiety (average of 42.6% improvement)

Major Adverse Events:
  •  Increased libido (7/16)
   • Mild forgetfulness (5/16)
   • Word-finding problems (3/16)
Franzini
(2010)
Deep-brain
stimulation
of the nucleus
accumbens in
obsessive
compulsive
disorder:
clinical, surgical
and
electrophysiological
considerations
in two consecutive patients
Italy
---
none mentioned
Condition with Bilateral NAcc Stimulation
 vs
Condition before Implantation
2 • Adult males (ages 33 - 41)
• Severe OCD for at least 5 years
• Failure of 4 pharmaceutical and behavioral therapy treatment regimens
• No previous
or current psychotic, personality,
or neurologic disorders

• No substance abuse

Co-Morbid Conditions:
  
Major Depressive Disorder (1/2)
   Bipolar Disorder (1/2)
Prospective Cohort Study

(no mention
of ethical review)

Length:
25.5
± 2.12
months

•Significant improvement seen at last-follow-up (average of 38.2%)

•Improvement in concurrent depression (average of 57.7% improvement)
•Improvement in overall daily function (average of 50% improvement)

Major Adverse Events:
   None

Investigational Brain Stimulation Target: Subthalamic Nucleus (STN)

Mallet
(2008)
Subthalamic
nucleus
stimulation in severe
obsessive-compulsive
disorder
France
---
• Programme Hospitalier de la Recherche Clinique Assistance Publique–Hôpitaux de Paris
• Agence Nationale de la Recherche Program for Young Researchers
Condition after Bilateral STN Stimulation
vs
Condition before Implantation
17 • Adults (ages 18-60)
• Severe OCD for at least 5 years
• Failure of 4 pharmaceutical and behavioral therapy treatment regimens
• No previous
or current psychotic, personality,
or neurologic disorders

• No substance abuse

Co-Morbid Conditions:
  
Major Depressive Disorder (6/17)
Double
Blinded

Crossover Study

Approved by the Institutional Ethics Committee
and in accordance with the Helsinki Declaration

Length:
10 months
(6 months blinded)

• Significant improvement seen with 3 months of stimulation (average of 36.7%)
• Greater improvement with active stimulation
  (average OCD score 32.1% better)

• Improvement in overall daily function (average of 33.3% improvement)
• Greater improvement in function with active stimulation
  (average score 30.2% better)

• No significant change in concurrent anxiety

Major Adverse Events:
   •
Intracranial hemorrhage (1/17)
   • Infection resulting in device removal (2/17)

Investigational Brain Stimulation Target: Inferior Thalamic Peduncle (ITP)

Jimenez-
Ponce

(2009)
Preliminary
study in
patients with obsessive-
compulsive
disorder
treated with electrical
stimulation
in the inferior
thalamic
peduncle
Mexico
---
none
Condition after Bilateral ITP Stimulation
 vs
Condition before Implantation
5 • Adults (ages 21-65)
• Severe OCD for at least 5 years
• Failure of 3 pharmaceutical and behavioral therapy treatment regimens, each lasting at least 6 months
• No previous
or current psychotic, personality,
or neurologic disorders

• No substance abuse

Co-Morbid Conditions:
  
Past Substance Abuse (3/5)
   Schizoid Personality (1/5)
Prospective Cohort Study

Approved
by the Institutional Ethics Committee
and in accordance with the Helsinki Declaration

Length:
12 months

• Significant improvement seen at 12 months (average of 49.1% improvement)
• All patients had at least a 44% improvement in their OCD score

• Improvement in overall daily function (average of 300% improvement)

Major Adverse Events
:
   None


Compiled during 2012-2013 by International Neuromodulation Society member Chengyuan Wu, MD, MSBmE, Thomas Jefferson University Hospital, Department of Neurosurgery and second-year medical student Lekhaj Daggubati, Drexel University School of Medicine

Additional reference:

Deep brain stimulation for obsessive-compulsive disorder: systematic review and evidence-based guideline sponsored by the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons (CNS) and Endorsed by the CNS and American Association of Neurological Surgeons, Clement Hamani, et al., Neurosurgery, doi: 10.1227/NEU.0000000000000499, published online 22 September 2014.


Please note: This information should not be used as a substitute for medical treatment and advice. Always consult a medical professional about any health-related questions or concerns.

 

 

Last Updated on Friday, June 16, 2017 08:18 AM