tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study

Obsessive-compulsive Disorders and Symptoms Clinical Trial

— tDCS-TOC  

Official title:

Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284671
• Other study ID #: tDCS-TOC pilote
• Status: Completed
• Phase: N/A
• First received: September 7, 2017
• Last updated: September 12, 2017
• Start date: February 19, 2016
• Est. completion date: May 12, 2017

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Henri Laborit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 12, 2017
• Est. primary completion date: February 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Patients must present all of the following criteria in order to be eligible:

Inclusion Criteria:

• Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS),

• Age: Participants will be both males and females, 18-70 years of age included.

• No current depressive and suicidal risks,

• No epileptic pathology,

• Chronic evolution ( Total Y-BOCS>20 ),

• Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year,

• Stability treatment (antidepressants) for more than 12 weeks without significant improvement,

• Affiliation to a social security system (recipient or assignee),

• Signed written inform consent form.

Exclusion Criteria:

• Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,

• Patient under curators

• Meets another diagnosis of axe 1 of DSM-IV,

• Current depressive or suicidal risks,

• Patient with a benzodiazepine treatment,

• Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) ,

• Epileptic patient,

• Patient with a medical history of cranial trauma,

• Patient unable to give his or hers informed consent.

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder
• Obsessive-compulsive Disorders and Symptoms

Intervention

Other:
• bifocal stimulation with tDCS
Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment	Score improvement on the Y-BOCS after 14 days compared to the baseline	Day 14
Secondary	Evaluate the persistence of therapeutic response at 45 days	Score improvement on the Y-BOCS after 45 days compared to the baseline	Day 45
Secondary	Evaluate the persistence of therapeutic response at 105 days	Score improvement on the Y-BOCS after 105 days compared to the baseline	Day 105
Secondary	Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days	Score improvement of Hamilton and HDRS scales between the baseline and day 14	Day 14
Secondary	Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days	Score improvement of Hamilton and HDRS scales between the baseline and day 45	Day 45
Secondary	Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days	Score improvement of Hamilton and HDRS scales between the baseline and day 105	Day 105
Secondary	Evaluate the effect of tDCS on the quality of life at day 14	Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14	Day 14
Secondary	Evaluate the effect of tDCS on the quality of life at day 45	Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45	Day 45
Secondary	Evaluate the effect of tDCS on global functioning at day 14	Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14	Day 14
Secondary	Evaluate the effect of tDCS on global functioning at day 45	Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45	Day 45
Secondary	Evaluate the effect of tDCS on social adjustment at day 14	Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14	Day 14
Secondary	Evaluate the effect of tDCS on social adjustement at day 45	Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45	Day 45