Deep brain stimulation for intractable obsessive-compulsive disorders.

JRCT ID: jRCTs042180039

Registered date:06/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Intractable obsessive-compulsive disorders
• Date of first enrollment: 06/02/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): The DBS electtrodes are inplanted under MRI guidance into both sides of anterior limb of internal capsule, and on the same day, the brain stimulation devices is implanted subcutaneously on anterior chest or under the pectoralis major muscle. Brain stimulation is started after the surgical safety is secured.

Outcome(s)

• Primary Outcome: more than 35% improvement of Yale Brown Obsessive Compulsive Scale (Y-BOCS) at 12 months after the initiation of AIC/VS-DBS.
• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1.One who meets the diagnostic criteria of OCD in DSM - 5.
2.The severity of symptoms of OCD is 30/40 or more with Y - BOCS score, and those who go to outpatient hospital or stay in the hospital for examination.
3.Persons whose score on the Global Assessment of Functioning (GAF) scale is 45 or less.
4.Those aged 20 years or over and under 70.
5.Persons who have obsessive compulsive disorder for more than 5 years.
6.Meanwhile, those who are resistant to drug therapy with three or more types of anxiolytic drugs, antidepressants, antipsychotic drugs and are sufficiently resistant to cognitive behavioral therapy.

Exclude criteria

1.Persons who have other mental disorders (autism, schizophrenia, bipolar disorder), brain diseases (epilepsy, a history of severe head injury, severe stroke, severe neurodegenerative disease). However, tic disorder, Tourette syndrome is excluded
2.Person who has a history of drug dependence.
3.Patients with diseases that are considered to be at high risk of physical and mental complications for surgery (severe cardiovascular disorder, severe respiratory dysfunction, severe blood disease).
4.Pregnant women / lactating women and women who may be pregnant.
5.Other things that the research staff deems inappropriate.

Related Information

• Primary Sponsor: Nozaki Takao
• Secondary ID(s): UMIN000022969