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Completed

NCT Number: NCT03284671

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

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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Key information

Conditions

Obsessive-compulsive Disorders and Symptoms Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bifocal stimulation with tDCS

Other

Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)

Primary outcomes

  1. 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

    Time frame: Day 14

    Score improvement on the Y-BOCS after 14 days compared to the baseline

Secondary outcomes

  1. Evaluate the persistence of therapeutic response at 45 days

    Time frame: Day 45

    Score improvement on the Y-BOCS after 45 days compared to the baseline

  2. Evaluate the persistence of therapeutic response at 105 days

    Time frame: Day 105

    Score improvement on the Y-BOCS after 105 days compared to the baseline

  3. Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days

    Time frame: Day 14

    Score improvement of Hamilton and HDRS scales between the baseline and day 14

  4. Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days

    Time frame: Day 45

    Score improvement of Hamilton and HDRS scales between the baseline and day 45

  5. Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days

    Time frame: Day 105

    Score improvement of Hamilton and HDRS scales between the baseline and day 105

  6. Evaluate the effect of tDCS on the quality of life at day 14

    Time frame: Day 14

    Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14

  7. Evaluate the effect of tDCS on the quality of life at day 45

    Time frame: Day 45

    Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45

  8. Evaluate the effect of tDCS on global functioning at day 14

    Time frame: Day 14

    Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14

  9. Evaluate the effect of tDCS on global functioning at day 45

    Time frame: Day 45

    Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45

  10. Evaluate the effect of tDCS on social adjustment at day 14

    Time frame: Day 14

    Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14

  11. Evaluate the effect of tDCS on social adjustement at day 45

    Time frame: Day 45

    Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Official study title

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

Acronym: tDCS-TOC

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 15, 2017
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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