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| Name | Class |
|---|---|
| Region Västerbotten | OTHER_GOV |
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The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).
The main research questions are:
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Active Comparator | Deep brain stimulation - active stimulation |
|
| Sham stimulation | Sham Comparator | Deep brain stimulation - no stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | Stimulation through a device implanted bilaterally into deep brain structures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale, Y-BOCS | Validated psychometric scale that measures symptoms of OCD. | From enrollment to the end of treatment after 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Scale, HAS | Validated psychometric scale that measures symptoms of anxiety. | From enrollment to the end of treatment after 6 months. |
| Hamilton Depression scale, HAMD | Validated psychometric scale that measures symptoms of depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktoria Johansson, PhD | Contact | +46-90-786 50 00 | viktoria.johansson@umu.se | |
| Matilda Naesstrom, PhD | Contact | +46-90-786 50 00 | matilda.naesstrom@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Patric Blomstedt, Professor | Umeå University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umeå University | Recruiting | Umeå | Västerbotten County | 90187 | Sweden |
We will not share IPD until the study is finished and results are published.
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Randomized controlled trial.
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The participant and the outcome assessor are blinded to whether the participant receives active or sham stimulation.
| From enrollment to the end of treatment after 6 months. |
| Montgomery Asberg Depression Rating Scale, MADRS | Validated psychometric scale that measures symptoms of depression. | From enrollment to the end of treatment after 6 months. |
| Global Assessment of Functioning, GAF | Scale that measures level of functioning. | From enrollment to the end of treatment after 6 months. |
| Clinical Global Impression rating scale, CGI | Scale that measures symptom improvement. | From enrollment to the end of treatment after 6 months. |