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Deep brain stimulation (DBS) offers an effective and safe treatment for patients with debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although several target areas for DBS have been used for OCD, such as the ventral capsule/ventral striatum and the subthalamic nucleus, not all patients show a clinical response, varying from 10% to 61.5%. Exploring new DBS targets may be a key approach to improve this situation. The habenula is an evolutionarily conserved structure playing an important role in depression, punishment avoiding, reward, addiction, pain and circadian rhythms. The habenula can be considered a promising target for OCD treatment based on the following hypotheses and clinical observations.
These theoretical and clinical considerations indicate that the habenula can be seen as a promising DBS target for OCD treatment. This study is focused on the effectiveness of bilateral DBS of the habenula for patients with treatment-refractory OCD. Furthermore, the study is aimed at exploring the influence of DBS of the habenula on brain activity and cognition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS | Experimental | All subjects will undergo bilateral surgical implantation of DBS system to habenula. The DBS system will be active at one week after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral surgical implantation of DBS system to habenula | Device | The DBS device utilized in the present study may include the Medtronic, PINS and SceneRay DBS device depending on patients' choice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Y-BOCSII Score | The score of the scale ranges from 0 to 50 | Baseline (preoperative),1 month, 3 months,6 months, 9 months |
| Change in OCI-R Score | The score of the scale ranges from 0 to 72 | Baseline (preoperative),1 month, 3 months,6 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the Hamilton Depression Scale(HAMD-17) | The score of the scale ranges from 0 to 50 | Baseline(preoperative),1 month, 3 months, 6 months,9 months |
| changes in the Hamilton Anxiety Scale(HAMA-14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingying Zhang, MSc | Contact | +086-17602137369 | zhyy019@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospital Functional Neurosurgery | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26208305 | Background | Alonso P, Cuadras D, Gabriels L, Denys D, Goodman W, Greenberg BD, Jimenez-Ponce F, Kuhn J, Lenartz D, Mallet L, Nuttin B, Real E, Segalas C, Schuurman R, du Montcel ST, Menchon JM. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015 Jul 24;10(7):e0133591. doi: 10.1371/journal.pone.0133591. eCollection 2015. | |
| 29406245 |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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All subjects will receive bilateral surgical implantation of DBS system
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The score of the scale ranges from 0 to 56
| Baseline(preoperative),1 month, 3 months, 6 months,9 months |
| changes in FMRI signal | The FMRI signal is to estimate Blood Oxygenation Level Dependent (BOLD) and connectivity of brain areas | Baseline(preoperative),3 month, 6 months, 9 months |
| changes in World Health Organization Quality of Life-BREF(WHO-BREF) | Baseline(preoperative),1 month, 3 months,6 months,9 months |
| changes the MOS item short from health survey (SF-36) | Baseline(preoperative),1 month, 3 months,6 months,9 months |
| Neuropsychological measures(Scores of cogstate battery) | Neuropsychological measures contains six tasks which are detection task, identification task, one card learning task, one back task, Groton maze learning task, set-shifting task | Baseline(preoperative),1 month, 3months,6months,9months |
| Background |
| Kohl S, Baldermann JC. Progress and challenges in deep brain stimulation for obsessive-compulsive disorder. Pharmacol Ther. 2018 Jun;186:168-175. doi: 10.1016/j.pharmthera.2018.01.011. Epub 2018 Jan 31. |
| 28384832 | Background | Hirschtritt ME, Bloch MH, Mathews CA. Obsessive-Compulsive Disorder: Advances in Diagnosis and Treatment. JAMA. 2017 Apr 4;317(13):1358-1367. doi: 10.1001/jama.2017.2200. |
| 28576510 | Background | Batalla A, Homberg JR, Lipina TV, Sescousse G, Luijten M, Ivanova SA, Schellekens AFA, Loonen AJM. The role of the habenula in the transition from reward to misery in substance use and mood disorders. Neurosci Biobehav Rev. 2017 Sep;80:276-285. doi: 10.1016/j.neubiorev.2017.03.019. Epub 2017 May 30. |
| 28223096 | Background | Fakhoury M. The habenula in psychiatric disorders: More than three decades of translational investigation. Neurosci Biobehav Rev. 2017 Dec;83:721-735. doi: 10.1016/j.neubiorev.2017.02.010. Epub 2017 Feb 13. |
| 25476971 | Background | Antolin-Fontes B, Ables JL, Gorlich A, Ibanez-Tallon I. The habenulo-interpeduncular pathway in nicotine aversion and withdrawal. Neuropharmacology. 2015 Sep;96(Pt B):213-22. doi: 10.1016/j.neuropharm.2014.11.019. Epub 2014 Dec 2. |
| 27527822 | Background | Boulos LJ, Darcq E, Kieffer BL. Translating the Habenula-From Rodents to Humans. Biol Psychiatry. 2017 Feb 15;81(4):296-305. doi: 10.1016/j.biopsych.2016.06.003. Epub 2016 Jun 7. |