A Phase 4 interventional study of Active DBS and Sham DBS in Obsessive-Compulsive Disorder, sponsored by Butler Hospital. Status unknown at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Butler Hospital · Phase 4, Interventional, and Treatment
This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder.
Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of adults in the United States. People with OCD often experience persistent unwanted thoughts and carry out ritual-like behaviors to rid themselves of these obsessive thoughts. Additionally, OCD symptoms are usually tied with feelings of intense anxiety and functional impairment, making it important for people with OCD to seek effective treatment. Although there are currently many treatment options for OCD, including psychotherapy and medications such as serotonin reuptake inhibitors, between 40% and 60% of people with OCD only partially respond or do not respond at all to these treatment methods. Given the large percentage of people who do not respond to aggressive conventional treatments, alternative options are necessary for people with treatment-resistant OCD. Deep brain stimulation (DBS) is a procedure that involves the use of thin wires to carry electric current to parts of the brain associated with producing OCD symptoms. DBS has been effectively and safely used to treat movement disorders, such as Parkinson's disease, and may be beneficial in reducing OCD symptom severity. This study will evaluate the safety and effectiveness of DBS in treating people with severe and otherwise treatment-resistant OCD.
Study participation through follow-up will last 4 years. Participants will be allowed to remain on any pre-surgical medications or behavioral therapy programs throughout the study. Before surgery, all participants will undergo a 3- to 4-day series of initial tests and examinations that will include a physical and neurological examination; blood and urine screening tests; an electrocardiogram (EKG); an electroencephalography (EEG); and detailed psychological testing, including tests of perception, learning, and memory. The EEGs may be performed again after surgery to measure potential changes in brain electrical activity due to DBS.
On the day of the surgery, participants will take a low dose of anxiety medication, have a metal frame fixed to their heads for support during surgery, and undergo a magnetic resonance imaging (MRI) scan to determine where to place the stimulating wires. After being injected with a local anesthetic, participants will undergo the first part of the operation, which will involve the implantation of neurostimulators in the ventral caudate/ventral striatum brain region. For the second part of the operation, after participants are administered general anesthesia, they will have the implantable neurostimulators (INSs) placed in their chests and the connecting wires to the brain placed under their skin. The entire surgical procedure will take 3 to 4 hours, with a 1- to 2-day post-operative hospital stay for recovery. During the post-operative stay, participants will undergo x-rays and a computed tomography (CT) scan of the head.
Two to 3 weeks after surgery, participants will be divided randomly into either a group that receives DBS immediately or a group that first receives sham DBS and then active DBS after 3 months. The level of stimulation will be adjusted individually and on the basis of each participant's response to the stimulation. Participants will complete rating forms, a clinical evaluation, and a check of the stimulators every month for the first 3 months, then at least every 3 months for the rest of the year, and then every 6 months for the remaining years of the study. On the Year 1 visit, participants will repeat the baseline detailed psychological testing. Periodically throughout the 4-year study, staff will contact participants by phone to ask about OCD symptoms, mood, anxiety, and possible side effects. Also throughout the study, participants will need to have the INSs replaced every 5 to 16 months on average.
Participants will also be invited to participate in a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional and will not affect current study participation.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's enrollment of 27 is below the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Butler Hospital is the lead sponsor of 118 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Documented highly treatment refractory illness; the documentation must demonstrate persistence of severe symptoms and impairment for 5 or more years despite at least three first-line and two second-line treatments, as follows:
Exclusion Criteria:
Participants will receive deep brain stimulation.
Device: Active DBS
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Device: Active DBS · Device: 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 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.
Also known as: Activa Deep Brain Stimulation System (Medtronic, Inc.), Implantable Neurostimulator (INS)
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.
Also known as: Activa Deep Brain Stimulation System (Medtronic, Inc.), Implantable Neurostimulator (INS)
Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings)
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.
Time frame: YBOCS total score observed means at month-12
Global Assessment of Functioning Scale (GAF)
A 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.
Time frame: GAF score observed means at month-12
Social and Occupational Functioning Assessment Scale (SOFAS)
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.
Time frame: SOFAS score observed means at month-12 time point.
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
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.
Time frame: QLESQ total score observed means at month-12 time point.
Montgomery-Asberg Depression Rating Scale (MADRS)
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
Time frame: MADRS total score observed means at month-12 time point.
Hamilton Anxiety Rating Scale (HARS)
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.
Time frame: HARS total score observed means at month-12 time point.
Behavioral Activation for Depression Scale (BADS)
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.
Time frame: Total BADS score observed means at month-12 time point.
Hamilton Depression Rating Scale (HDRS)
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.
Time frame: Total HDRS score observed means at month-3 time point.
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.
| Milestone | Active DBS | Sham DBS |
|---|---|---|
| Started | 15 | 12 |
| Completed | 15 | 12 |
| Not completed | 0 | 0 |
| Milestone | Active DBS | Sham DBS |
|---|---|---|
| Started | 27 | 0 |
| Completed | 24 | 0 |
| Not completed | 3 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings) | 20.5 ± 10.6 | 20.9 ± 7.0 |
A 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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Global Assessment of Functioning Scale (GAF) | 54.8 ± 16.5 | 53.7 ± 8.2 |
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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Social and Occupational Functioning Assessment Scale (SOFAS) | 55.9 ± 16.0 | 53.9 ± 7.1 |
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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) | 39.8 ± 12.8 | 42.7 ± 8.4 |
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
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 17.1 ± 12.8 | 18.5 ± 10.1 |
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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Hamilton Anxiety Rating Scale (HARS) | 12.6 ± 8.8 | 15.7 ± 11.4 |
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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Behavioral Activation for Depression Scale (BADS) | 85.3 ± 28.9 | 80.3 ± 22.7 |
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.
| units on a scale | Active DBS | Sham DBS |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | 16.8 ± 9.6 | 19.4 ± 13.9 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active DBS | 0/15 (0%) | 3/15 (20%) | 10/15 (66.7%) |
| Sham DBS | 0/12 (0%) | 1/12 (8.3%) | 7/12 (58.3%) |
| Event | Active DBS | Sham DBS |
|---|---|---|
| InfectionInjury, poisoning and procedural complications | 0/15 | 1/12 |
| Symptom worseningNervous system disorders | 1/15 | 0/12 |
| Motor effect (fall)Nervous system disorders | 1/15 | 0/12 |
| Periorbital swellingInjury, poisoning and procedural complications | 1/15 | 0/12 |
| Event | Active DBS | Sham DBS |
|---|---|---|
| Symptom worseningNervous system disorders | 4/15 | 4/12 |
| GI discomfort/symptomsGastrointestinal disorders | 1/15 | 3/12 |
| HypomaniaNervous system disorders | 1/15 | 2/12 |
| Headache/migraineNervous system disorders | 1/15 | 2/12 |
| Post-surgical discomfort/painInjury, poisoning and procedural complications | 2/15 | 1/12 |
| InfectionInjury, poisoning and procedural complications | 2/15 | 0/12 |
| Tiredness/severe fatigueNervous system disorders | 2/15 | 0/12 |
| InsomniaNervous system disorders | 0/15 | 1/12 |
| Alcohol-related eventNervous system disorders | 1/15 | 0/12 |
| Pocket stimulationInjury, poisoning and procedural complications | 1/15 | 0/12 |
| Age, Continuous(years) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| Mean | 43.3 ± 12.9 | 35.1 ± 10.5 | 39.6 ± 12.4 |
| Sex: Female, Male(Participants) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 9 | 7 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 14 | 12 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 15 | 10 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| United States | 15 | 12 | 27 |
| Yale-Brown Obsessive-Compulsive Scale (YBOCS)(units on a scale) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| Mean | 33.3 ± 2.3 | 33.5 ± 2.3 | 33.5 ± 2.3 |
| Global Assessment of Functioning (GAF)(units on a scale) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| Mean | 37.0 ± 6.8 | 41.6 ± 2.9 | 39.0 ± 5.8 |
| Social and Occupational Functioning Assessment Scale (SOFAS)(units on a scale) | Active DBS | Sham DBS | Total |
|---|---|---|---|
| Mean | 38.5 ± 8.0 | 41.5 ± 3.9 | 39.9 ± 6.6 |
5 further baseline measures are reported on the registry.
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Obsessive-Compulsive Disorder →