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Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation (PERSONA)

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ClinicalTrials.gov Identifier: NCT02476435
Recruitment Status : Unknown
Verified October 2017 by Centre Hospitalier St Anne.
Recruitment status was:  Recruiting
First Posted : June 19, 2015
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier St Anne

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

Condition or disease Intervention/treatment Phase
Depersonalization Disorder Device: Active rTMS Device: Placebo rTMS Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.
Actual Study Start Date : June 19, 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental = Active rTMS
Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Device: Active rTMS
Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Other Name: Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks

Placebo Comparator: Sham Comparator = Sham rTMS
Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Device: Placebo rTMS
Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks
Other Name: Magstim Super-Rapid2, Neuronavigation system Visor (ANT)




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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 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


  4. Cambridge Depersonalization Scale (CDS) [ Time Frame: At 3 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 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



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients:

  • Outpatients aged over 18 years old
  • Suffering from depersonalization disorder according to DSM IV-TR
  • Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and must be continued at the same dose(s) through the duration of the study.
  • Patient provided informed written consent
  • Patient covered by a contributory social security scheme

Controls:

  • Aged over 18 years old
  • Absence of a personal history of psychiatric disorders
  • Provided informed written consent
  • Covered by a contributory social security scheme

Exclusion Criteria:

  • Patients:
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
  • Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  • history of neurosurgery,
  • neurosurgical ventriculoperitoneal bypass valves
  • personal and / or family history of seizures or epilepsy
  • Dental device
  • Pregnant woman
  • Claustrophobic subjects
  • Not cooperating or agitated patients
  • Medications that reduce the seizure threshold, such as clozapine, bupropion, methadone and / or theophylline
  • Alcohol abuse and / or toxic substances in the last 12 months
  • Substance dependence except tobacco

Controls:

  • Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
  • Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  • neurosurgical ventriculoperitoneal bypass valves
  • Claustrophobic subjects
  • Pregnant woman
  • Not cooperating or agitated patients
  • Dental device

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): NCT02476435


Contacts
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Contact: Marion PLAZE, MD, PhD 00 33 1 45 65 76 65 m.plaze@ch-sainte-anne.fr
Contact: Marie GODARD 00 33 1 45 65 77 28 marie.godard@aphp.fr

Locations
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France
Saint-Antoine Hospital Not yet recruiting
Paris, France, 75012
Contact: Stéphane MOUCHABAC, MD       stephane.mouchabac@aphp.fr   
Centre Hospitalier Sainte-Anne Recruiting
Paris, France, 75014
Contact: Marion PLAZE, MD, PhD       m.plaze@ch-sainte-anne.fr   
Sponsors and Collaborators
Centre Hospitalier St Anne
Publications:

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Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT02476435    
Other Study ID Numbers: D14-P009
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Keywords provided by Centre Hospitalier St Anne:
Depersonalization
Derealization
Embodiment
Emotional numbing
Transcranial magnetic stimulation
Angular gyrus
Temporo-parietal junction
Additional relevant MeSH terms:
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Depersonalization
Behavioral Symptoms