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

Primary Purpose

Depersonalization Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active rTMS
Placebo rTMS
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depersonalization Disorder focused on measuring Depersonalization, Derealization, Embodiment, Emotional numbing, Transcranial magnetic stimulation, Angular gyrus, Temporo-parietal junction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint-Antoine Hospital
  • Centre Hospitalier Sainte-AnneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental = Active rTMS

Sham Comparator = Sham rTMS

Arm Description

Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks

Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks

Outcomes

Primary Outcome Measures

Cambridge Depersonalization Scale (CDS)
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)
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)
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)
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

Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS
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
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
Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.

Full Information

First Posted
June 11, 2015
Last Updated
October 18, 2017
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT02476435
Brief Title
Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation
Acronym
PERSONA
Official Title
Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2015 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depersonalization Disorder
Keywords
Depersonalization, Derealization, Embodiment, Emotional numbing, Transcranial magnetic stimulation, Angular gyrus, Temporo-parietal junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental = Active rTMS
Arm Type
Active Comparator
Arm Description
Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Arm Title
Sham Comparator = Sham rTMS
Arm Type
Placebo Comparator
Arm Description
Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Intervention Type
Device
Intervention Name(s)
Active rTMS
Other Intervention Name(s)
Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Intervention Description
Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Intervention Type
Device
Intervention Name(s)
Placebo rTMS
Other Intervention Name(s)
Magstim Super-Rapid2, Neuronavigation system Visor (ANT)
Intervention Description
Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks
Primary Outcome Measure Information:
Title
Cambridge Depersonalization Scale (CDS)
Description
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
Time Frame
At 3 weeks (in the end of the treatment)
Title
Cambridge Depersonalization Scale (CDS)
Description
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
Time Frame
At 1 month after the treatment
Title
Cambridge Depersonalization Scale (CDS)
Description
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
Time Frame
At 2 months after the treatment
Title
Cambridge Depersonalization Scale (CDS)
Description
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
Time Frame
At 3 months after the treatment
Secondary Outcome Measure Information:
Title
Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS
Description
maintenance of reduction of at least 50% of the original score to the depersonalization scale of Cambridge.
Time Frame
At 3 months
Title
Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
Description
Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
Time Frame
Baseline
Title
Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
Description
Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
Time Frame
Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion PLAZE, MD, PhD
Phone
00 33 1 45 65 76 65
Email
m.plaze@ch-sainte-anne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie GODARD
Phone
00 33 1 45 65 77 28
Email
marie.godard@aphp.fr
Facility Information:
Facility Name
Saint-Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane MOUCHABAC, MD
Email
stephane.mouchabac@aphp.fr
Facility Name
Centre Hospitalier Sainte-Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion PLAZE, MD, PhD
Email
m.plaze@ch-sainte-anne.fr

12. IPD Sharing Statement

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Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

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