Clinical Trial: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.

Brief Summary: The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.

Detailed Summary: Depersonalization disorder is characterised by a profound disruption of self-awareness. Depersonalization symptoms may occasionally arise (30 to 70% of the population) or may become chronic in depersonalization disorder. Its prevalence is around 2.4% in the general population. This disorder is particularly resistant to pharmacological treatments. This study is a randomized, double-blind, placebo-controlled study, and the investigators are testing the therapeutic efficacy of neuronavigated repetitive Transcranial Magnetic Stimulation (TMS) of right angular gyrus in patients with depersonalization disorder.
Sponsor: Centre Hospitalier St Anne

Current Primary Outcome:

  • Cambridge Depersonalization Scale (CDS) [ Time Frame: At 3 weeks (in the end of the treatment) ]

    The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder.

    The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale

  • Cambridge Depersonalization Scale (CDS) [ Time Frame: At 1 month after the treatment ]

    The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder.

    The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale

  • Cambridge Depersonalization Scale (CDS) [ Time Frame: At 2 months after the treatment ]

    The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS [ Time Frame: At 3 months ]
      maintenance of reduction of at least 50% of the original score to the depersonalization scale of Cambridge.
    • Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity [ Time Frame: Baseline ]
      Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
    • Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity [ Time Frame: Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS) ]
      Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.


    Original Secondary Outcome:

    • Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS [ Time Frame: At 3 months ]
      maintenance of reduction of at least 50% of the original score to the depersonalization scale of Cambridge.
    • Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity [ Time Frame: Baseline ]
      Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
    • Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity [ Time Frame: Visit 3 : end of the SMT sessions (between 19 and 25 days after V2 - start of SMT) ]
      Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.


    Information By: Centre Hospitalier St Anne

    Dates:
    Date Received: June 11, 2015
    Date Started: June 2015
    Date Completion: September 2019
    Last Updated: February 11, 2016
    Last Verified: February 2016