Investigation of Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder patients and their neuropsychological performance
Design
A study on 5 Refractory Obsessive-Compulsive Disorder patients
Settings and conduct
Before implantation the severity of OCD, Personality, and cognition of patient will be evaluated. The electrodes will be surgically bilateral implanted in the nucleus accumbens in Rasoul Akram Hospital, Iran University of Medical Sciences. Patients will receive stimulation and all outcomes will be recorded in 1 and 2 weeks after implantation. in addition, the outcomes will be recorded in every 1 month for 12 months follow up in school of Behavioral Sciences and Mental Health.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age: 16-65 Diagnosis and Severity: Sever and chronic OCD for at least 5 years, Yale-Brown scale at least 25, Hamilton scale at least 17, IQ more than 85 Treatment refractoriness: Not response for SSRI for 12 weeks, clomipramine 12 weeks, atypical antipsychotics for 6 weeks and CBT for 16 seasons
Exclusion criteria: Psychotic disorders, Dementia, Bipolar disorders, Autism, Parkinson, Substance use disorders, Personality Disorders, Pregnancy
Intervention groups
Deep Brain Stimulation and implantation of electrodes in Nucleus Accumbens
Main outcome variables
OCD severity; Depression and anxiety; cognitive performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030510N2
Registration date:2019-01-08, 1397/10/18
Registration timing:registered_while_recruiting
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Reza Arezoomandan
Name of organization / entity
Addiction Department, School of Behavioral Sciences and Mental Health (Institute of Tehran Psychiatr
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1658
Email address
arezoomandan.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2020-09-23, 1399/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Deep Brain Stimulation of Nucleus Accumbens for Treatment-Refractory Obsessive-Compulsive Disorder
Public title
Deep Brain Stimulation for Treatment of Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 16-65
Diagnosis and Severity: Sever and chronic OCD for at least 5 years, Yale-Brown scale at least 25, Hamilton scale at least 17, IQ more than 85
Treatment refractoriness: Not response for SSRI for 12 weeks, clomipramine 12 weeks, atypical antipsychotics for 6 weeks and CBT for 16 seasons
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2018-11-24, 1397/09/03
Ethics committee reference number
IR.IUMS.REC.1397.538
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
2
Description of health condition studied
Cognitive performance
ICD-10 code
F99
ICD-10 code description
Diseases of the nervous system
Primary outcomes
1
Description
Severity of OCD
Timepoint
every month
Method of measurement
Yale- Brown scale
2
Description
Neuropsychological performance
Timepoint
every month
Method of measurement
Neuropsychological tools
Secondary outcomes
1
Description
Side effects, such as headache, nausea and...
Timepoint
during the intervention and 2 months after that
Method of measurement
questionnaire or observation
Intervention groups
1
Description
Deep brain stimulation (DBS), a neurosurgical procedure involving the implantation of a medical device called a neurostimulator, which sends electrical impulses, through implanted electrodes, to specific targets in the brain (nucleus accumbens) and stimulate this nucleus. After surgery, stimulation will be 130 Hz, at pulse widths of 90 and 150 us and at 2–7 V. Stimulation will adjust in optimization phase base on improvements of patients and clinical outcomes.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasol Akram Hospital
Full name of responsible person
Reza Arezoomandan
Street address
Shahied Mansuri St, Niayesh St, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
14565-441
Phone
+98 21 6655 1656
Email
arezoomandan.r@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?