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Trial record 83 of 165 for:    personality AND therapy AND severity | Recruiting, Not yet recruiting, Available Studies

tDCS for Treatment Resistant Obsessive Compulsive Disorder (tDCS-TOC)

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ClinicalTrials.gov Identifier: NCT03304600
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Henri Laborit

Brief Summary:
It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Active stimulation Device: Sham stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active stimulation
10 sessions (1 per day during 2 week) of active tDCS stimulation
Device: Active stimulation
Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).

Sham Comparator: Sham Stimulation
10 sessions (1 per day during 2 week) of sham stimulation
Device: Sham stimulation
Patients will receive a Sham stimulation during 30 mn




Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale (YBOCS) score [ Time Frame: 2 weeks ]
    The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups


Secondary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Month 1 ]
    i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.

  2. Yale Brown Obsessive Compulsive Scale (YBOCS), [ Time Frame: Month 3 ]
    ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.

  3. Clinical Global Impression (CGI) [ Time Frame: Month 1 ]
    Change from baseline to month 1 in above scales between treatment groups;

  4. Clinical Global Impression (CGI) [ Time Frame: Month 3 ]
    Change from baseline to month 3 in above scales between treatment groups;

  5. Brown Assessment of Beliefs Scale (BABS) [ Time Frame: Month 1 ]
    Change from baseline to month 1 in above scales between treatment groups;

  6. Brown Assessment of Beliefs Scale (BABS) [ Time Frame: Month 3 ]
    Change from baseline to month 3 in above scales between treatment groups;

  7. Brief Anxiety Scale (BAS) [ Time Frame: Month 1 ]
    Change from baseline to month 1 in above scales between treatment groups;

  8. Brief Anxiety Scale (BAS) [ Time Frame: Month 3 ]
    Change from baseline to month 3 in above scales between treatment groups;

  9. Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: Month 1 ]
    Change from baseline to month 1 in above scales between treatment groups;

  10. Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: Month 3 ]
    Change from baseline to month 3 in above scales between treatment groups;

  11. Hospital Anxiety and Depression scale (HAD) [ Time Frame: Month 1 ]
    Change from baseline to month 1 in above scales between treatment groups;

  12. Hospital Anxiety and Depression scale (HAD) [ Time Frame: Month 3 ]
    Change from baseline to month 3 in above scales between treatment groups;

  13. Sheehan Disability Scale, (SDS) [ Time Frame: Month 1 ]
    Change from baseline to month 1 in above scales between treatment groups;

  14. Sheehan Disability Scale, (SDS) [ Time Frame: Month 3 ]
    Change from baseline to month 3 in above scales between treatment groups;


Other Outcome Measures:
  1. Number of adverse events [ Time Frame: 3 Month ]

    Safety of the tDCS treatment :

    • assessed by physical examination during each tDCS session
    • any other adverse events (AEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS)
  • No current depressive and suicidal risks
  • No epileptic pathology
  • Age: Participants will be both males and females, 18-70 years of age included.
  • Chronic Obsessive compulsive disorder ( Total Y-BOCS>20 or Y-BOCS one subscale > 15)
  • Obsessive compulsive disorder resistant to pharmacology treatment :

    1. at least 2 antidepressants (IRS type) (> 12 weeks)
    2. cognitive and comportment therapy since at least one year
  • Treatment stability (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
  • Patient hospitalized under duress
  • Meets another diagnosis of axe 1 of DSM-IV
  • Current depressive or suicidal risks
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304600


Contacts
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Contact: Damien HEIT, MD +33 5 16 52 61 18 damien.heit@ch-poitiers.fr
Contact: Nematollah Jaafari, MD.PhD +33 5 16 52 61 18 nemat.jaafari@ch-poitiers.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Jean-Marie VANELLE, Pr    +33 2.40.84.64.02    jeanmarie.vanelle@chu-nantes.fr   
Sub-Investigator: Anne SAUVAGET, MD         
Sub-Investigator: Samuel BULTEAU, MD         
Centre Hospitalier Henri Laborit Recruiting
Poitiers, France, 86021
Contact: Damien HEIT, MD    +33 5 16 52 61 18    damien.heit@ch-poitiers.fr   
Sub-Investigator: Nematollah JAAFARI, Pr         
Sub-Investigator: Ghina HARIKA-GERMANEAU, MD         
C.H. Guillaume Regnier Recruiting
Rennes, France, 35703
Contact: Dominique DRAPIER, Pr    +33 2 99 33 39 00    d.drapier@ch-guillaumeregnier.fr   
Sponsors and Collaborators
Centre Hospitalier Henri Laborit
Ministry of Health, France
Investigators
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Study Director: Damien HEIT, MD Centre Hospitalier Henri Laborit

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Responsible Party: Centre Hospitalier Henri Laborit
ClinicalTrials.gov Identifier: NCT03304600     History of Changes
Other Study ID Numbers: 2016-A01983-48
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Henri Laborit:
OCD
tDCS
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders