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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH076179 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATSO |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active DBS | Active Comparator | Participants will receive deep brain stimulation. |
|
| Sham DBS | Sham Comparator | Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active DBS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | SOFAS score observed means at month-12 time point. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30
Impaired functioning, indicated by a Global Assessment of Functioning (GAF) score of 45 or less
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:
Either drug free or on a stable drug regimen for at least 6 weeks before study entry
General good overall health
If possible, has a family member or significant other who sees the participant regularly, can communicate with the study team as needed, and, if necessary, can attend study visits
Local referring psychiatrist willing to provide ongoing care during and after the trial, to work closely with the research team, and to agree that the study psychiatrist will prescribe medications during the 3-month masked phase
Platelet count greater than 125,000 per cubic millimeter and a prothrombin time and partial thromboplastin time within normal limits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin D. Greenberg, MD, PhD | Butler Hospital/Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Redwood City Hospital | Redwood City | California | 94063 | United States | ||
| George Washington University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16855529 | Background | Greenberg BD, Malone DA, Friehs GM, Rezai AR, Kubu CS, Malloy PF, Salloway SP, Okun MS, Goodman WK, Rasmussen SA. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology. 2006 Nov;31(11):2384-93. doi: 10.1038/sj.npp.1301165. Epub 2006 Jul 19. | |
| 2684084 | Result | Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization Phase (Baseline-Month 3) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2019 | Sep 25, 2019 |
Not provided
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|
|
| Sham DBS | Device | 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. |
|
|
| 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 | 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. | 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. | 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. | Total HDRS score observed means at month-3 time point. |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| 8290681 | Result | Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6. |
| 444788 | Result | Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382. |
| Result | Kanter, J. W., Rusch, L. C., Busch, A. M., & Sedivy, S. K. (2009). Validation of the behavioral activation for depression scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment, 31, 36-42. |
| 13638508 | Result | HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available. |
| 14399272 | Result | HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available. |
| Result | American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders, (4th ed., text revision). Washington, DC: American Psychiatric Association. |
| 23128051 | Derived | McLaughlin NC, Didie ER, Machado AG, Haber SN, Eskandar EN, Greenberg BD. Improvements in anorexia symptoms after deep brain stimulation for intractable obsessive-compulsive disorder. Biol Psychiatry. 2013 May 1;73(9):e29-31. doi: 10.1016/j.biopsych.2012.09.015. Epub 2012 Nov 3. No abstract available. |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
| Open Label Phase (Month 4-12) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham DBS | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | All patients must receive follow-up and DBS programming at one of the 8 collaborative study sites. If a patient is not located within 2 hours of a study site, FDA-approval must be granted for additional study sites. | Count of Participants | Participants | No |
| ||||||||||||||
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) | 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 (each of the 10 items are rated 0-4; 4 being the most severe). Total scores are summed and range from 0-40. Higher scores for obsessions, compulsions and total score indicate more severe symptoms over the past week. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Global Assessment of Functioning (GAF) | The Global Assessment of Functioning (GAF) scale is 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Social and Occupational Functioning Assessment Scale (SOFAS) | The Social and Occupational Functioning Assessment (SOFAS) is 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| The 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Behavioral Activation Scale for Depression (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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | YBOCS total score observed means at month-12 |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | GAF score observed means at month-12 |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | SOFAS score observed means at month-12 time point. |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | QLESQ total score observed means at month-12 time point. |
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| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | MADRS total score observed means at month-12 time point. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | HARS total score observed means at month-12 time point. |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Total BADS score observed means at month-12 time point. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Total HDRS score observed means at month-3 time point. |
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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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 15 | 3 | 15 | 10 | 15 |
| EG001 | Sham DBS | 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. | 0 | 12 | 1 | 12 | 7 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptom worsening | Nervous system disorders | Systematic Assessment | Mood liability alternating between irritable, anger and sad, worsening to SI hurting self and wanting to die. |
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| Motor effect (fall) | Nervous system disorders | Systematic Assessment | Patient rolled out of bed and hit head. Went to ER, received 6 stitches on scalp. |
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| Periorbital swelling | Injury, poisoning and procedural complications | Systematic Assessment | Patient went to ER due to periorbital swelling. |
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| Infection | Injury, poisoning and procedural complications | Systematic Assessment | New infection, "boil," developed at implant site and expelled pus and blood. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptom worsening | Nervous system disorders | Systematic Assessment | Including increased anxiety, OCD, depression, |
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| Hypomania | Nervous system disorders | Systematic Assessment | Hypomania also including "elevated mood" |
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| Alcohol-related event | Nervous system disorders | Systematic Assessment | Fight and shoulder pain from drunken fall. |
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| Post-surgical discomfort/pain | Injury, poisoning and procedural complications | Systematic Assessment | Discomfort/pain/numbness after surgery |
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| Infection | Injury, poisoning and procedural complications | Systematic Assessment | Post-surgical infection |
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| Pocket stimulation | Injury, poisoning and procedural complications | Systematic Assessment | Side effect of the device. |
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| GI discomfort/symptoms | Gastrointestinal disorders | Systematic Assessment | GI discomfort including diarrhea, abdominal pain, and bleeding |
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| Headache/migraine | Nervous system disorders | Systematic Assessment | Headache/migraine (including chronic) |
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| Tiredness/severe fatigue | Nervous system disorders | Systematic Assessment | Tiredness up to severe fatigue |
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| Insomnia | Nervous system disorders | Systematic Assessment | Insomnia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Greenberg | Butler Hospital | (401) 455-6602 | 26602 | be3ngreenb@gmail.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2018 | Jul 9, 2018 | SAP_000.pdf |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D058542 | Implantable Neurostimulators |
| ID | Term |
|---|---|
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
Not provided
Not provided
| Adverse Event |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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