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

NCT03284671 — Not applicable, Completed, 20 participants, Centre Hospitalier Henri Laborit

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

RegistryNCT03284671, acronym tDCS-TOC
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment20 (Actual)
SponsorCentre Hospitalier Henri Laborit (Other)
ConditionsObsessive-compulsive Disorders and Symptoms
Interventionsbifocal stimulation with tDCS (Other)
Datesstart 2016-02-19, primary completion 2016-02-19, completion 2017-05-12, first posted 2017-09-15, last updated 2026-09-09
Locations1 site in France

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
bifocal stimulationExperimentalOther: bifocal stimulation with tDCSTranscranial direct current Bifocal stimulation
  • bifocal stimulation with tDCS (Other): Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)

+Outcome measures

Primary outcomes

  • 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 [Day 14]: Score improvement on the Y-BOCS after 14 days compared to the baseline

Secondary outcomes

  • Evaluate the persistence of therapeutic response at 45 days [Day 45]: Score improvement on the Y-BOCS after 45 days compared to the baseline
  • Evaluate the persistence of therapeutic response at 105 days [Day 105]: Score improvement on the Y-BOCS after 105 days compared to the baseline
  • Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days [Day 14]: Score improvement of Hamilton and HDRS scales between the baseline and day 14
  • Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days [Day 45]: Score improvement of Hamilton and HDRS scales between the baseline and day 45
  • Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days [Day 105]: Score improvement of Hamilton and HDRS scales between the baseline and day 105
  • Evaluate the effect of tDCS on the quality of life at day 14 [Day 14]: Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14
  • Evaluate the effect of tDCS on the quality of life at day 45 [Day 45]: Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45
  • Evaluate the effect of tDCS on global functioning at day 14 [Day 14]: Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14
  • Evaluate the effect of tDCS on global functioning at day 45 [Day 45]: Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45
  • Evaluate the effect of tDCS on social adjustment at day 14 [Day 14]: Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14
  • Evaluate the effect of tDCS on social adjustement at day 45 [Day 45]: Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

FacilityCityCountryStatus
Centre Hospitalier Henri LaboritPoitiersFrance

+Publications

  • Results publication: Harika-Germaneau G, Heit D, Chatard A, Thirioux B, Langbour N, Jaafari N. Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. Brain Behav. 2020 Jul;10(7):e01648. doi: 10.1002/brb3.1648. Epub 2020 May 14. PMID 32406608

+Investigators

  • Nematollah JAAFARI, Professor, Study director, Centre Hospitalier Henri Laborit

My Notes