Obsessive-Compulsive DisorderPhase 2NCT01061983
Electrical Stimulation of the Internal Capsule for Intractable Obsessive-compulsive Disorder (OCD)
A Phase 2 study testing Medtronic Activa Deep Brain Stimulation in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also expect to determine how DBS affects brain activity in brain circuits strongly implicated in OCD, and how such effects may relate to… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Medtronic Activa Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OCD, diagnosed by Structural Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity with a Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 28 and a Global Assessment of Function (GAF) score of 45 or less.
- Persistence of this level of impairment for a minimum of five years despite adequate trials of or intolerance to 3 or 4 selective serotonin transporter inhibitors including fluoxetine, sertraline, fluvoxamine, paroxetine and clomipramine alone and in combination with behavior therapy, and augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- Age of at least eighteen years, and no more than 55 years.
- Able to understand and comply with instructions.
- Written informed consent.
- Either drug free or on a stable drug regime for at least 6 weeks.
- Good general health.
Who cannot join
- Current or past psychotic disorder.
- Any clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
- Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery.
- Current or unstably remitted substance abuse disorder.
- Pregnancy and women of childbearing age not using effective contraception.
- History of body dysmorphic disorder.
- History of severe personality disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Stimulation of the Internal Capsule for Intractable OCD
This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also expect to determine how DBS affects brain activity in brain circuits strongly implicated in OCD, and how such effects may relate to symptom change. This treatment study therefore also permits a unique and crucial test of current neuroanatomical models of both OCD pathogenesis and mechanisms underlying the response to treatment.
Read the detailed description
Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of the adult population of 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 se 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 efficacy of DBS in treating people with severe and treatment-resistant OCD.
Study participation through follow-up will last up to 2 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 series of initial tests and examinations that will include psychiatric, medical, and neuropsychological histories and examinations.
Implantation of the devices will be performed at a single session. The leads that are inserted into the anterior limb of each internal capsule, will be implanted under local anesthesia. On the day of the surgery, participants will have a metal frame fixed to their heads for support during surgery, and magnetic resonance imagining (MRI) will be used to determine the exact placement of the wires. An extension wire will pass from the scalp area to the subclavicular region and connect each electrode to a subcutaneous implanted pulse generator (IPG), which will be implanted under general anesthesia. After placement of the DBS system, the patient will be admitted to the hospital for overnight observation for possible complications. Postoperative evaluation will consist of physical and neurological examinations, postoperative CBC, electrolyte panel, x-rays of the head, neck, and chest, a standard shunt series to ensure the integrity of connections, and a head CT scan to monitor for possible postoperative intracranial hemorrhage.
Surgical implantation will be followed by a three-week period with no stimulation, and then an intensive five-day preliminary outpatient stimulation trial, followed by longer-term outpatient stimulation. All patients will follow the same sequence of test conditions. The initial DBS testing will be open, followed by three blocks of testing in which the patients and investigators administering rating scales will not be informed of the stimulation condition. These three blocks will in general be three months long, but may be longer or shorter depending on the stability of any clinical improvement, and the possible emergence of symptom worsening. The remainder of the the study, up to the two-year study endpoint, will consist of a continuation phase of active open stimulation.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Medtronic Activa Deep Brain Stimulation
- Keywords
- Deep brain stimulation, Treatment refractory, Ventral internal capsule/ventral striatum, Neurosurgery, Neuroimaging
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Activa Deep Brain StimulationDevice
Also called Deep Brain Stimulation (DBS), Activa System, Medtronic Activa Deep Brain Stimulation Therapy System
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Participants will receive deep brain stimulation. Receives: Device: Medtronic Activa Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive disorder (OCD) severity (Yale-Brown Obsessive-Compulsive Scale)
Measured: Measured at baseline, then monthly for nine months, then every three months during the open continuation phase
Secondary outcomes (1)
Depression severity (Hamilton Depression Scale), Anxiety (Hamilton Anxiety Scale), and neuropsychological battery.
Measured: At baseline, monthly for 9 months, then every 3 months for the continuation of the open phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2001
- Primary completionApr 2004
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Dr. Benjamin Greenberg, Butler Hospital
- Investigators
- Benjamin D Greenberg, MD, PhD, Principal investigator, Butler Hospital/Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061983
- Sponsor's protocol ID
- 000204
- Status last verified
- Feb 2013
- First submitted
- 2 Feb 2010
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greenberg BD, Gabriels LA, Malone DA Jr, Rezai AR, Friehs GM, Okun MS, Shapira NA, Foote KD, Cosyns PR, Kubu CS, Malloy PF, Salloway SP, Giftakis JE, Rise MT, Machado AG, Baker KB, Stypulkowski PH, Goodman WK, Rasmussen SA, Nuttin BJ. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Mol Psychiatry. 2010 Jan;15(1):64-79. doi: 10.1038/mp.2008.55. Epub 2008 May 20.
PubMed 18490925Greenberg 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.
PubMed 16855529Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.
PubMed 16619660
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation of the Internal Capsule for Intractable OCD
- ClinicalTrials.gov ID
- NCT01061983
- Acronym / sponsor ID
- 000204
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Deep brain stimulation, Treatment refractory, Ventral internal capsule/ventral striatum, Neurosurgery, Neuroimaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also expect to determine how DBS affects brain activity in brain circuits strongly implicated in OCD, and how such effects may relate to symptom change. This treatment study therefore also permits a unique and crucial test of current neuroanatomical models of both OCD pathogenesis and mechanisms underlying the response to treatment.
Detailed description
Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of the adult population of 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 se 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 efficacy of DBS in treating people with severe and treatment-resistant OCD.
Study participation through follow-up will last up to 2 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 series of initial tests and examinations that will include psychiatric, medical, and neuropsychological histories and examinations.
Implantation of the devices will be performed at a single session. The leads that are inserted into the anterior limb of each internal capsule, will be implanted under local anesthesia. On the day of the surgery, participants will have a metal frame fixed to their heads for support during surgery, and magnetic resonance imagining (MRI) will be used to determine the exact placement of the wires. An extension wire will pass from the scalp area to the subclavicular region and connect each electrode to a subcutaneous implanted pulse generator (IPG), which will be implanted under general anesthesia. After placement of the DBS system, the patient will be admitted to the hospital for overnight observation for possible complications. Postoperative evaluation will consist of physical and neurological examinations, postoperative CBC, electrolyte panel, x-rays of the head, neck, and chest, a standard shunt series to ensure the integrity of connections, and a head CT scan to monitor for possible postoperative intracranial hemorrhage.
Surgical implantation will be followed by a three-week period with no stimulation, and then an intensive five-day preliminary outpatient stimulation trial, followed by longer-term outpatient stimulation. All patients will follow the same sequence of test conditions. The initial DBS testing will be open, followed by three blocks of testing in which the patients and investigators administering rating scales will not be informed of the stimulation condition. These three blocks will in general be three months long, but may be longer or shorter depending on the stability of any clinical improvement, and the possible emergence of symptom worsening. The remainder of the the study, up to the two-year study endpoint, will consist of a continuation phase of active open stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Medtronic Activa Deep Brain StimulationParticipants will receive deep brain stimulation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- OCD, diagnosed by Structural Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity with a Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 28 and a Global Assessment of Function (GAF) score of 45 or less.
- Persistence of this level of impairment for a minimum of five years despite adequate trials of or intolerance to 3 or 4 selective serotonin transporter inhibitors including fluoxetine, sertraline, fluvoxamine, paroxetine and clomipramine alone and in combination with behavior therapy, and augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- Age of at least eighteen years, and no more than 55 years.
- Able to understand and comply with instructions.
- Written informed consent.
Key exclusion criteria (8 listed)
- Current or past psychotic disorder.
- Any clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
- Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery.
- Current or unstably remitted substance abuse disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Activa Deep Brain StimulationAlso: Deep Brain Stimulation (DBS), Activa System, Medtronic Activa Deep Brain Stimulation Therapy SystemIn 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. | Device | Deep Brain Stimulation |
Primary outcome
Obsessive-compulsive disorder (OCD) severity (Yale-Brown Obsessive-Compulsive Scale)
Time frame: Measured at baseline, then monthly for nine months, then every three months during the open continuation phase
1 secondary outcome
Depression severity (Hamilton Depression Scale), Anxiety (Hamilton Anxiety Scale), and neuropsychological battery.
Time frame: At baseline, monthly for 9 months, then every 3 months for the continuation of the open phase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Results publication: PubMed 18490925Greenberg BD, Gabriels LA, Malone DA Jr, Rezai AR, Friehs GM, Okun MS, Shapira NA, Foote KD, Cosyns PR, Kubu CS, Malloy PF, Salloway SP, Giftakis JE, Rise MT, Machado AG, Baker KB, Stypulkowski PH, Goodman WK, Rasmussen SA, Nuttin BJ. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Mol Psychiatry. 2010 Jan;15(1):64-79. doi: 10.1038/mp.2008.55. Epub 2008 May 20.
- Results publication: PubMed 16855529Greenberg 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.
- Results publication: PubMed 16619660Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.
Related trials for Obsessive-Compulsive Disorder
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin D Greenberg, MD, PhD principal investigator
Butler Hospital/Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medtronic Activa Deep Brain Stimulation in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive disorder (OCD) severity (Yale-Brown Obsessive-Compulsive Scale) (time frame: Measured at baseline, then monthly for nine months, then every three months during the open continuation phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061983, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.