Trial Outcomes & Findings for Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder (NCT NCT00640133)
NCT ID: NCT00640133
Last Updated: 2024-07-29
Results Overview
The Yale-Brown Obsessive-Compulsive Scale (YBOCS) is a 10 question evaluator-administered measure assessing the severity of obsessions and compulsions over the past week. Obsession and compulsion severity are evaluated separately (ratings from 0-20 for each category) with total scores ranging from 0-40. Higher scores for obsessions, compulsions and total score indicate more severe symptoms over the past week.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
YBOCS total score observed means at month-12
Results posted on
2024-07-29
Participant Flow
The study is a parallel controlled design. Patients (n=27) were assigned to a condition by site \& gender via urn randomization to receive three months of double-masked sham or double-masked active DBS. After 3 months, all patients received open-label active DBS. 12 patients were in the sham group while 15 patients received active DBS immediately.
Participant milestones
| Measure |
Active DBS
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
Participants will receive sham deep brain stimulation for three months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
|---|---|---|
|
Randomization Phase (Baseline-Month 3)
STARTED
|
15
|
12
|
|
Randomization Phase (Baseline-Month 3)
COMPLETED
|
15
|
12
|
|
Randomization Phase (Baseline-Month 3)
NOT COMPLETED
|
0
|
0
|
|
Open Label Phase (Month 4-12)
STARTED
|
27
|
0
|
|
Open Label Phase (Month 4-12)
COMPLETED
|
24
|
0
|
|
Open Label Phase (Month 4-12)
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Active DBS
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
Participants will receive sham deep brain stimulation for three months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
|---|---|---|
|
Open Label Phase (Month 4-12)
Lack of Efficacy
|
1
|
0
|
|
Open Label Phase (Month 4-12)
Withdrawal by Subject
|
1
|
0
|
|
Open Label Phase (Month 4-12)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder
Baseline characteristics by cohort
| Measure |
Active DBS
n=15 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for 3 months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
|
33.3 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Global Assessment of Functioning (GAF)
|
37.0 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
41.6 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
39.0 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Social and Occupational Functioning Assessment Scale (SOFAS)
|
38.5 units on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
41.5 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
39.9 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
|
36.7 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
37.6 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
The Montgomery Asberg Depression Rating Scale (MADRS)
|
25.6 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 13.5 • n=7 Participants
|
22.7 units on a scale
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Hamilton Anxiety Rating Scale (HARS)
|
19.3 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 10.3 • n=7 Participants
|
17.6 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Behavioral Activation Scale for Depression (BADS)
|
67.5 units on a scale
STANDARD_DEVIATION 25.4 • n=5 Participants
|
72.0 units on a scale
STANDARD_DEVIATION 17.6 • n=7 Participants
|
69.7 units on a scale
STANDARD_DEVIATION 21.8 • n=5 Participants
|
|
Hamilton Depression Rating Scale (HDRS)
|
29.0 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 11.3 • n=7 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: YBOCS total score observed means at month-12The Yale-Brown Obsessive-Compulsive Scale (YBOCS) is a 10 question evaluator-administered measure assessing the severity of obsessions and compulsions over the past week. Obsession and compulsion severity are evaluated separately (ratings from 0-20 for each category) with total scores ranging from 0-40. Higher scores for obsessions, compulsions and total score indicate more severe symptoms over the past week.
Outcome measures
| Measure |
Active DBS
n=12 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings)
|
20.5 units on a scale
Standard Deviation 10.6
|
20.9 units on a scale
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: GAF score observed means at month-12A numeric scale (0 through 100) used to rate the social, occupational, and psychological overall functioning during the week of poorest functioning in the past month. Higher scores indicate a higher level of functioning, while low scores indicate impaired global functioning.
Outcome measures
| Measure |
Active DBS
n=12 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Global Assessment of Functioning Scale (GAF)
|
54.8 units on a scale
Standard Deviation 16.5
|
53.7 units on a scale
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: SOFAS score observed means at month-12 time point.A numeric scale (0 through 100) used to rate the social, occupational, and psychological functioning during the week of poorest functioning in the past month. Higher scores indicate higher levels of social and occupational functioning, while low scores represent social and occupational impairment.
Outcome measures
| Measure |
Active DBS
n=12 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Social and Occupational Functioning Assessment Scale (SOFAS)
|
55.9 units on a scale
Standard Deviation 16.0
|
53.9 units on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: QLESQ total score observed means at month-12 time point.Population: In total, 4 participants receiving active DBS did not complete Q-LES-Q ratings at month 12; 3 participants exited the protocol before the month-12 endpoint and 1 participant had incomplete Q-LES-Q data.
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-administered measure to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. We used the 16-item short form with total scores ranging from 16-80. Higher scores indicate greater satisfaction experienced during the past week.
Outcome measures
| Measure |
Active DBS
n=11 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
|
39.8 units on a scale
Standard Deviation 12.8
|
42.7 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: MADRS total score observed means at month-12 time point.Population: In total, 4 participants receiving active DBS did not complete MADRS ratings at month 12; 3 participants exited the protocol before the month-12 endpoint and 1 participant had incomplete MADRS data.
The Montgomery Asberg Depression Rating Scale (MADRS) is an interviewer-administered measure assessing the ten symptoms of depression most sensitive to change. Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts are assessed and total scores range from 0-60 with higher scores representing the presence of more severe depression over the past week. interviewer-administered measure assessing
Outcome measures
| Measure |
Active DBS
n=11 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
17.1 units on a scale
Standard Deviation 12.8
|
18.5 units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: HARS total score observed means at month-12 time point.Hamilton Anxiety Rating Scale (HARS) is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety); total scores range from 0-56. Higher scores indicate higher levels of anxiety over the past week.
Outcome measures
| Measure |
Active DBS
n=12 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Hamilton Anxiety Rating Scale (HARS)
|
12.6 units on a scale
Standard Deviation 8.8
|
15.7 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Total BADS score observed means at month-12 time point.Population: In total, 4 participants receiving active DBS did not complete BADS ratings at month 12; 3 participants exited the protocol before the month-12 endpoint and 1 participant had incomplete BADS data.
The Behavioral Activation for Depression Scale (BADS) is a 29-item scale that measures the role of aversive controlling stimuli and escape and avoidance behavior in depression, specifically when and how participants become more activated over the course of treatment. Total scores range from 29-203 and lower scores indicate higher levels of escape and avoidance behavior from depression in the past week.
Outcome measures
| Measure |
Active DBS
n=11 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Behavioral Activation for Depression Scale (BADS)
|
85.3 units on a scale
Standard Deviation 28.9
|
80.3 units on a scale
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Total HDRS score observed means at month-3 time point.The Hamilton Depression Rating Scale (HDRS) measures the severity of depressive symptoms in adults. The evaluator-administered ratings measure depressed mood, guilt, suicide, insomnia, work/activities, retardation, agitation, psychic and somatic anxiety, genital symptoms, hypochondriasis, and insight during the past week. Total scores range from 0-72 and higher scores indicate the presence of more severe depression over the past week. Note: this measure was only administered at baseline and month-3.
Outcome measures
| Measure |
Active DBS
n=15 Participants
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 Participants
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS)
|
16.8 units on a scale
Standard Deviation 9.6
|
19.4 units on a scale
Standard Deviation 13.9
|
Adverse Events
Active DBS
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Sham DBS
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active DBS
n=15 participants at risk
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 participants at risk
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Nervous system disorders
Symptom worsening
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Nervous system disorders
Motor effect (fall)
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Injury, poisoning and procedural complications
Periorbital swelling
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Injury, poisoning and procedural complications
Infection
|
0.00%
0/15 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
8.3%
1/12 • Number of events 1 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
Other adverse events
| Measure |
Active DBS
n=15 participants at risk
Participants will receive deep brain stimulation.
Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
|
Sham DBS
n=12 participants at risk
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.
Afterwards, all participants will receive open-label long-term DBS.
|
|---|---|---|
|
Nervous system disorders
Symptom worsening
|
26.7%
4/15 • Number of events 9 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
33.3%
4/12 • Number of events 8 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Nervous system disorders
Hypomania
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
16.7%
2/12 • Number of events 3 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Nervous system disorders
Alcohol-related event
|
6.7%
1/15 • Number of events 2 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Injury, poisoning and procedural complications
Post-surgical discomfort/pain
|
13.3%
2/15 • Number of events 4 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
8.3%
1/12 • Number of events 1 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Injury, poisoning and procedural complications
Infection
|
13.3%
2/15 • Number of events 2 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Injury, poisoning and procedural complications
Pocket stimulation
|
6.7%
1/15 • Number of events 3 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Gastrointestinal disorders
GI discomfort/symptoms
|
6.7%
1/15 • Number of events 2 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
25.0%
3/12 • Number of events 4 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Nervous system disorders
Headache/migraine
|
6.7%
1/15 • Number of events 3 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
16.7%
2/12 • Number of events 2 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Nervous system disorders
Tiredness/severe fatigue
|
13.3%
2/15 • Number of events 3 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
0.00%
0/12 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/15 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
8.3%
1/12 • Number of events 2 • Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place