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The aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible adverse effects / complications of the procedure.
About ten patients with severe and refractory OCD will receive bilateral single lesions at the bottom of the anterior limb of the internal capsule by linear accelerator. Prior to the procedure, a detailed clinical and psychiatric evaluation, plus an extensive battery of psychiatric diagnostic tests, severity and progression of OCD, depression / anxiety symptoms, presence of tics, psychosocial impairment, quality of life, familial accommodation and neuropsychological and personality testes will be performed. Furthermore, the patients will be also assessed by serological and neuroimaging tests. The Individuals will be periodically evaluated and followed up for one year. The results of the scores of the rating scales will be analyzed and compared, as well as the profile of adverse events, cognitive or personality changes and improves in clinical tests and neuroimaging studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Radiosurgery by linear accelerator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Radiation | Only one radiation session of about 180 Gy in bilateral internal capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in OCD symptoms | Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale | Every 3 months until 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life. | Application of "Medical Outcomes Study 36-Item Short-Form Health Survey" (SF-36) scale | Every 3 months until 12 months |
| Change in brain-derived neurotrophic factor (BDNF) blood dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulo Abreu, M.D.; Ph.D. | Contact | 555133598294 | paulo.abreu@ufrgs.br | |
| Marcelo Sousa, M.D.; M.Sc | Contact | 555199557634 | mbsousa@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Abreu, M.D.; Ph.D. | Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 277059 | Background | Asberg M, Montgomery SA, Perris C, Schalling D, Sedvall G. A comprehensive psychopathological rating scale. Acta Psychiatr Scand Suppl. 1978;(271):5-27. doi: 10.1111/j.1600-0447.1978.tb02357.x. No abstract available. | |
| 5337782 | Background | Ballantine HT Jr, Cassidy WL, Flanagan NB, Marino R Jr. Stereotaxic anterior cingulotomy for neuropsychiatric illness and intractable pain. J Neurosurg. 1967 May;26(5):488-95. doi: 10.3171/jns.1967.26.5.0488. No abstract available. |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Serological blood tests
| 12 months |
| Change in psychological tests | Application of:
| 12 months |
| Side effects and complications | Application of "Systematic Assessment for Treatment Emergent Effects" (SAFTEE) Event List and Interview. | Every 3 months until 12 months |
| Change in familial accommodation | Application of "Family Accommodation Scale for Obsessive-Compulsive Disorder" (FAS) | Every 3 months until 12 months |
| Change in anxiety symptoms. | Application of "Beck Anxiety Inventory" (BAI) scale | Every 3 months until 12 months |
| Change in depressive symptoms. | Application of "Beck Depression Inventory" (BDI) scale | Every 3 months until 12 months |
| Change in near-infrared spectroscopy (NIRS) brain blood flow | During application of Stroop psychological test. | 12 months |
| Change in OCD symptoms by CPRS | Application of "Comprehensive Psychopathological Rating Scale" (CPRS) | Every 3 months |
| Change in OCD symptoms by NIMH. | Application of "National Institute of Mental Health Global Obsessive-Compulsive Scale" (NIMH OCD Scale) | Every 3 months |
| Change in Global Functioning | Application of "Global Assessment of Functioning Scale" (GAF) | Every 3 months until 12 months |
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |