Advertisement

Topics

Radiosurgical Treatment for Obsessive-compulsive Disorder

2014-07-23 21:11:56 | BioPortfolio

Summary

Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can be indicated. Among various surgical techniques, Gamma Knife radiosurgery has the advantage of not requiring the production of burr hole openings in the skull. However, there are no randomized controlled trials of radiosurgical procedures.

The investigators' aim is to investigate whether radiosurgery for the treatment of severe and refractory OCD is efficacious and safe, by a double-blind, randomized controlled trial. Forty-eight refractory OCD patients will be randomized into two different groups: the first one will receive standard radiosurgery; the second group will be submitted to a false radiosurgery ("sham operation"). Patients who had been previously submitted to sham surgery will be able to undergo real operations after one year of follow-up, when blinding is broken. For a minimum period of one year, patients will be periodically followed-up in terms of psychiatric changes (including OCD symptoms), global functioning, cognitive/personality changes and neuroimaging findings.

Description

Various studies have demonstrated that good treatment responses in Obsessive Compulsive Disorder (OCD) are often obtained in 60 to 80 % of patients, whether employing serotonin reuptake inhibitors or behavior therapy. However, a subgroup of OCD patients are refractory to the classical therapeutic options, even after maximum dosage regimens and sufficiently long treatment follow-ups are devised. Severe psychosocial and occupational impairments are meanwhile observable. These subjects are often referred to stereotactic neurosurgeries. Among the various surgical techniques, a radiosurgical modality (double-shot ventral capsular/ventral striatal - VC/VS gamma capsulotomy, or simply double-shot gamma ventral capsulotomy) has been recently developed. On the other hand, there are no randomized controlled trials of Gamma Knife radiosurgeries in Psychiatry.

The aim of this study is to investigate whether double-shot VC/VS gamma capsulotomy is efficacious and to describe its adverse events/complications profiles, in a double-blind, randomized controlled trial of this radiosurgical technique for the treatment of refractory OCD.

Forty-eight refractory OCD patients will be randomized into two different groups: the first one will receive standard radiosurgery; the second group will be submitted to a false radiosurgical intervention ("sham operation"). All subjects will be previously assessed by a preliminary clinical/psychiatric interview, as well as by extensive specific instruments regarding psychiatric diagnosis, OCD evolution and severity, anxiety/depression symptoms, tics expression, psychosocial impairment, personality changes, etc. A neuropsychological tests battery will also be employed. All patients will be offered a periodical follow-up, during which assessment scales and neuroimaging exams (magnetic resonance imaging) will be repeated. Patients who had been previously submitted to placebo surgery will be able to undergo real operations after the one-year follow-up period, when blinding is broken. Scores results will be analyzed among the groups, as well as adverse events profiles, cognitive/personality changes, clinical global functioning and neuroimaging findings. Improvements in Yale-Brown Obsessive Compulsive Scale (YBOCS) and Clinical Global Impression (CGI) scores will be taken as the primary treatment response criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Obsessive-Compulsive Disorder

Intervention

ventral capsular/ventral striatal gamma capsulotomy

Location

Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
São Paulo
SP
Brazil
01060970

Status

Recruiting

Source

University of Sao Paulo General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:56-0400

Clinical Trials [474 Associated Clinical Trials listed on BioPortfolio]

Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder

Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment...

Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder

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 symptom...

Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder

Deep brain stimulation(DBS) has been beneficial to many patients with debilitating, refractory obsessive-compulsive disorder(OCD). Although several target areas for DBS have been used for ...

Deep Brain Stimulation for Severe Obsessive Compulsive Disorder

The overarching aim is to compare the effects of ventral capsule/ventral striatum (VC/VS) and subthalamic nucleus (STN) deep brain stimulation (DBS) in the same participants. Investigators...

Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome

The purpose of this study is to determine the safety and efficacy of Deep Brian Stimulation (DBS) of the ventral capsular/ventral striatal as a treatment for patients with Thalamic Pain Sy...

PubMed Articles [1599 Associated PubMed Articles listed on BioPortfolio]

Gamma Ventral Capsulotomy in Intractable Obsessive-Compulsive Disorder.

Despite the development of effective pharmacologic and cognitive behavioral treatments for obsessive-compulsive disorder (OCD), some patients continue to be treatment-refractory and severely impaired....

Personality measures after gamma ventral capsulotomy in intractable OCD.

Neurosurgeries such as gamma ventral capsulotomy (GVC) are an option for otherwise intractable obsessive-compulsive disorder (OCD) patients. In general, clinical and neuropsychological status both imp...

Human striatal response to reward anticipation linked to hippocampal glutamate levels.

Dysfunctional reward processing is associated with a number of psychiatric disorders, such as addiction and schizophrenia. It is thought that reward is regulated mainly by dopamine transmission in th...

Complex Ventral Hernias: A Review of Past to Present.

With the incidence of ventral hernias increasing, surgeons are faced with greater complexity in dealing with these conditions. Proper knowledge of the history and the advancements made in managing com...

Proposal for a national triage system for the management of ventral hernias.

Ventral hernia disease is becoming increasingly prevalent and complex. Subspecialisation for patients with challenging conditions requiring surgery has been shown to improve postoperative outcomes. Wo...

Medical and Biotech [MESH] Definitions

A large group of nuclei lying between the internal medullary lamina and the internal capsule. It includes the ventral anterior, ventral lateral, and ventral posterior nuclei.

The region of the telencephalon located rostral and ventral to the STRIATUM comprising AMYGDALA; SEPTAL NUCLEI; SUBSTANTIA INNOMINATA and ventral pallidum.

Region in the ventral TELENCEPHALON located anterior to the OPTIC CHIASM, posterior to the OLFACTORY PEDUNCLE, rostral to the PIRIFORM AREA and ventral to the NUCLEUS ACCUMBENS.

The front part of hindbrain that lies between MEDULLA OBLONGATA and the midbrain (MESENCEPHALON) ventral to the CEREBELLUM. It is composed of two parts, the dorsal and the ventral. Pons serves as a relay station for important neural pathways between the cerebellum to the CEREBRUM.

A region in the mesencephalon which is dorsomedial to the substantia nigra and ventral to the red nucleus. The mesocortical and mesolimbic dopaminergic systems originate here, including an important projection to the nucleus accumbens. Overactivity of the cells in this area has been suspected to contribute to the positive symptoms of schizophrenia.

More From BioPortfolio on "Radiosurgical Treatment for Obsessive-compulsive Disorder"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...


Searches Linking to this Trial