Obsessive-Compulsive DisorderNCT03894397
Evaluating Unilateral Deep Brain Stimulation in Patients With Obsessive Compulsive Disorder
A study testing Electrical stimulation of the BNST in people with Obsessive-Compulsive Disorder, run by KU Leuven at 1 site in Belgium.
Trial summary
The investigators previously showed that deep brain stimulation (DBS) in the bed nucleus of the stria terminalis (BNST) reduces symptoms in patients with severe obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Electrical stimulation of the BNST
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Mar 2019to 1 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of obsessive-compulsive disorder
- Implanted with DBS system in the bilateral BST (or max. 4mm removed from the BST outline)
- At least three months of chronic BST stimulation
- Compulsive behavior can be provoked within a clinical setting
Who cannot join
- Personality changes evoked by chronic DBS
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Unilateral Deep Brain Stimulation (DBS) of the Bed Nucleus of the Stria Terminalis (BNST) in Patients With Obsessive Compulsive Disorder (OCD)
The investigators previously showed that deep brain stimulation (DBS) in the bed nucleus of the stria terminalis (BNST) reduces symptoms in patients with severe obsessive-compulsive disorder (OCD). Although most patients now receive bilateral stimulation, multiple studies suggest that stimulation of the left BNST might be equally effective.
In this study, the investigators will evaluate the effect of unilateral stimulation in OCD patients who currently receive bilateral BNST stimulation to treat their symptoms. We hypothesize that unilateral stimulation of the left BNST will reduce anxious and depressive symptoms, compared to no stimulation.
The study entails a double-blinded, randomized cross-over design during which every patient undergoes four stimulation conditions: stimulation of the left, right or bilateral BNST, or no stimulation. During every condition, which takes about fifteen minutes, the patient is exposed to an individually determined stimulus that normally elicits OCD-related symptoms. The patients are then asked to fill out a short questionnaire to evaluate the severity of their symptoms during the four conditions. At the end of the cross-over phase, the stimulation parameters of each patient are restored.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Electrical stimulation of the BNST
- Keywords
- (Unilateral) Deep brain stimulation, Anxiety, Mood
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation of the BNSTDevice
Electrical stimulation of the BNST
| Study group | Role | What they receive |
|---|---|---|
| Stimulation of left BNST | Experimental | Not described Receives: Device: Electrical stimulation of the BNST |
| Stimulation of right BNST | Experimental | Not described Receives: Device: Electrical stimulation of the BNST |
| Stimulation of bilateral BNST | Experimental | Not described Receives: Device: Electrical stimulation of the BNST |
| Stimulation OFF | Placebo comparator | Not described Receives: Device: Electrical stimulation of the BNST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) ratings of mood and anxiety/stress
For every question on the VAS, there will be a line of 10 centimeters as an outcome measure. The patient will place a mark on this line, in correspondence to their symptoms. The minimum is 0%, which corresponds to no symptoms at all. The maximum is 100% (marker at the end of the 10 centimeter line), and indicates the most severe symptoms. Every millimiter that the mark is removed from the left boundary of the line, is considered as 1%. Measurements of mood and anxiety/stress will be scored using 2 VAS scales. We will only look at sub score, not total scores. A higher score corresponds to more severe symptoms. By using a continuous line as an outcome rather than fixed numbers (1-2-3-...), our rating is far more sensitive to small deviations in how symptoms are experienced.
Measured: After 15 minutes of stimulation
Secondary outcomes (1)
VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing
For every question on the VAS, there will be a line of 10 centimeters as an outcome measure. The patient will place a mark on this line, in correspondence to their symptoms. The minimum is 0%, which corresponds to no symptoms at all. The maximum is 100% (marker at the end of the 10 centimeter line), and indicates the most severe symptoms. For global wellbeing, a higher score corresponds to better therapeutic effects. Every millimiter that the mark is removed from the left boundary of the line, is considered as 1%. Obsessive thoughts, urge to perform compulsions, avoidance and global wellbeing will be measured using four separate VAS scales. We will only look at sub score, not total scores. By using a continuous line as an outcome rather than fixed numbers (1-2-3-...), our rating is far more sensitive to small deviations in how symptoms are experienced. For obsessive thoughts, urge to perform compulsions and avoidance, a higher score indicates more severe symptoms.
Measured: After 15 minutes of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start26 Mar 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- We will evaluate the effect of unilateral and bilateral stimulation of the BNST. Four conditions will be evaluated: left BNST stimulation, right BNST stimulation, bilateral BNST stimulation or no stimulation (OFF). Note that the order of these conditions is stratified beforehand (www.random.org). Each condition takes around 15 minutes.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Luyck, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894397
- Sponsor's protocol ID
- S62175
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Unilateral Deep Brain Stimulation (DBS) of the Bed Nucleus of the Stria Terminalis (BNST) in Patients With Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT03894397
- Acronym / sponsor ID
- S62175
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- (Unilateral) Deep brain stimulation, Anxiety, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 28 Mar 2019 (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.
The investigators previously showed that deep brain stimulation (DBS) in the bed nucleus of the stria terminalis (BNST) reduces symptoms in patients with severe obsessive-compulsive disorder (OCD). Although most patients now receive bilateral stimulation, multiple studies suggest that stimulation of the left BNST might be equally effective.
In this study, the investigators will evaluate the effect of unilateral stimulation in OCD patients who currently receive bilateral BNST stimulation to treat their symptoms. We hypothesize that unilateral stimulation of the left BNST will reduce anxious and depressive symptoms, compared to no stimulation.
The study entails a double-blinded, randomized cross-over design during which every patient undergoes four stimulation conditions: stimulation of the left, right or bilateral BNST, or no stimulation. During every condition, which takes about fifteen minutes, the patient is exposed to an individually determined stimulus that normally elicits OCD-related symptoms. The patients are then asked to fill out a short questionnaire to evaluate the severity of their symptoms during the four conditions. At the end of the cross-over phase, the stimulation parameters of each patient are restored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- We will evaluate the effect of unilateral and bilateral stimulation of the BNST. Four conditions will be evaluated: left BNST stimulation, right BNST stimulation, bilateral BNST stimulation or no stimulation (OFF). Note that the order of these conditions is stratified beforehand (www.random.org). Each condition takes around 15 minutes.
| Arm | Type | Receives |
|---|---|---|
| Stimulation of left BNST | Experimental | Device: Electrical stimulation of the BNST |
| Stimulation of right BNST | Experimental | Device: Electrical stimulation of the BNST |
| Stimulation of bilateral BNST | Experimental | Device: Electrical stimulation of the BNST |
| Stimulation OFF | Placebo comparator | Device: Electrical stimulation of the BNST |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of obsessive-compulsive disorder
- Implanted with DBS system in the bilateral BST (or max. 4mm removed from the BST outline)
- At least three months of chronic BST stimulation
- Compulsive behavior can be provoked within a clinical setting
Key exclusion criteria (2 listed)
- Personality changes evoked by chronic DBS
- Cognitive impairment
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 |
|---|---|---|
| Electrical stimulation of the BNSTElectrical stimulation of the BNST | Device | Stimulation OFF, Stimulation of bilateral BNST, Stimulation of left BNST, Stimulation of right BNST |
Primary outcome
Visual analogue scale (VAS) ratings of mood and anxiety/stress
Time frame: After 15 minutes of stimulation
For every question on the VAS, there will be a line of 10 centimeters as an outcome measure. The patient will place a mark on this line, in correspondence to their symptoms. The minimum is 0%, which corresponds to no symptoms at all. The maximum is 100% (marker at the end of the 10 centimeter line), and indicates the most severe symptoms. Every millimiter that the mark is removed from the left boundary of the line, is considered as 1%. Measurements of mood and anxiety/stress will be scored using 2 VAS scales. We will only look at sub score, not total scores. A higher score corresponds to more severe symptoms. By using a continuous line as an outcome rather than fixed numbers (1-2-3-...), our rating is far more sensitive to small deviations in how symptoms are experienced.
1 secondary outcome
VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing
Time frame: After 15 minutes of stimulation
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 4 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation of the BNST in people with Obsessive-Compulsive Disorder, run by KU Leuven at 1 site in Belgium.
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 4 Sep 2019. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Visual analogue scale (VAS) ratings of mood and anxiety/stress (time frame: After 15 minutes of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.