Obsessive-Compulsive DisorderDBS in OCDNCT04919785
Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
A study testing Deep brain stimulation in people with Obsessive-Compulsive Disorder, run by University Hospital, Umeå.
Trial summary
Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jan 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV
- YBOCS score of at least 25/40
- Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT
- Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent.
Who cannot join
- Current psychotic or substance abuse disorder
- Clinically significant medical disorder, or previous brain surgery
About this study
Official title: Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-compulsive Disorder
Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep brain stimulation
- Keywords
- Deep brain stimulation, Bed nucleus of stria terminalis, Obsessive-compulsive disorder
- 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.
Deep brain stimulationDevice
Stereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days.
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation | Experimental | Deep brain stimulation in the bed nucleus of stria terminalis Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS
The primary outcome measure was the psychiatrist-rated YBOCS at one year, with response defined as ≥ 35% decrease in YBOCS score and partial response as a 25-34% decrease. In YBOCS is a 10-item clinically rated scale where the items are divided by obsessions and compulsions. The scale measures the severity of OCD by time spent on obsessions/compulsions, level of anxiety and decrease of functioning caused by OCD symptoms and ability to control obsessions and compulsions. Maximum points on the scale are 40, where 0-7 points indicates subclinical, 8-15 mild, 16-23 moderate, 24 - 32 severe and 33- 40 extreme OCD symptoms
Measured: 1 year
Secondary outcomes (2)
Measuring the effect on depressive symptoms after treatment with DBS in the bed nucleus of stria terminalis using the Montgomery-Asberg Depressive Rating Scale
The Montgomery-Asberg Depressive Rating Scale is a 10-item clinically rated scale of common symptoms in major depressive disorder. The scale measures severity of depressive symptoms with a maximum score of 60 where 0-6 indicates normal levels, 7 - 19 mild, 20 - 34 moderate and >34 severe depression.
Measured: 1 year
Measuring the effect on functioning after treatment with DBS in the bed nucleus of stria terminalis using the Global Assessment of Functioning scale
The Global Assessment of Functioning is a numeric clinician rating scale to rate social, occupational, and psychological functioning. Scores range from 100 (high function) to 0 (sever impairment).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study startSep 2008
- Primary completionNov 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Umeå
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matilda Naesström, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919785
- Sponsor's protocol ID
- 08-090M
- Acronym
- DBS in OCD
- Status last verified
- Jun 2021
- First submitted
- 7 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naesstrom M, Blomstedt P, Bodlund O. A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Nord J Psychiatry. 2016 Oct;70(7):483-91. doi: 10.3109/08039488.2016.1162846. Epub 2016 Apr 22.
PubMed 27103550Naesstrom M, Hariz M, Stromsten L, Bodlund O, Blomstedt P. Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-Compulsive Disorder-1-Year Follow-up. World Neurosurg. 2021 May;149:e794-e802. doi: 10.1016/j.wneu.2021.01.097. Epub 2021 Feb 1.
PubMed 33540102
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT04919785
- Acronym / sponsor ID
- DBS in OCD / 08-090M
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Deep brain stimulation, Bed nucleus of stria terminalis, Obsessive-compulsive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, UmeåUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 9 Jun 2021 (actual)
- 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.
Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.
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: Deep brain stimulationDeep brain stimulation in the bed nucleus of stria terminalis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV
- YBOCS score of at least 25/40
- Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT
- Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent.
Key exclusion criteria (2 listed)
- Current psychotic or substance abuse disorder
- Clinically significant medical disorder, or previous brain surgery
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 |
|---|---|---|
| Deep brain stimulationStereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days. | Device | Deep brain stimulation |
Primary outcome
Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS
Time frame: 1 year
The primary outcome measure was the psychiatrist-rated YBOCS at one year, with response defined as ≥ 35% decrease in YBOCS score and partial response as a 25-34% decrease. In YBOCS is a 10-item clinically rated scale where the items are divided by obsessions and compulsions. The scale measures the severity of OCD by time spent on obsessions/compulsions, level of anxiety and decrease of functioning caused by OCD symptoms and ability to control obsessions and compulsions. Maximum points on the scale are 40, where 0-7 points indicates subclinical, 8-15 mild, 16-23 moderate, 24 - 32 severe and 33- 40 extreme OCD symptoms
2 secondary outcomes
Measuring the effect on depressive symptoms after treatment with DBS in the bed nucleus of stria terminalis using the Montgomery-Asberg Depressive Rating Scale
Time frame: 1 year
Measuring the effect on functioning after treatment with DBS in the bed nucleus of stria terminalis using the Global Assessment of Functioning scale
Time frame: 1 year
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 9 Jun 2021.
- Background: PubMed 27103550Naesstrom M, Blomstedt P, Bodlund O. A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Nord J Psychiatry. 2016 Oct;70(7):483-91. doi: 10.3109/08039488.2016.1162846. Epub 2016 Apr 22.
- Results publication: PubMed 33540102Naesstrom M, Hariz M, Stromsten L, Bodlund O, Blomstedt P. Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-Compulsive Disorder-1-Year Follow-up. World Neurosurg. 2021 May;149:e794-e802. doi: 10.1016/j.wneu.2021.01.097. Epub 2021 Feb 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Obsessive-Compulsive Disorder, run by University Hospital, Umeå.
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 4 inclusion and 2 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS (time frame: 1 year). 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 NCT04919785, which also lists 2 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 9 Jun 2021.