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

October 31, 2023 updated by: Centre Hospitalier St Anne

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Centre Hospitalier Sainte-Anne
      • Paris, France, 75012
        • Saint-Antoine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Magstim Super-Rapid2, Neuronavigation system Visor (ANT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 3 weeks (in the end of the treatment)
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
At 1 month after the treatment
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
At 2 months after the treatment
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
At 3 months after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 3 months
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.
Baseline
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.
Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier St Anne

Investigators

  • Principal Investigator: Marion Plaze, MD, PhD, GHU Paris Psychiatrie & Neurosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2015

Primary Completion (Actual)

October 10, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimated)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D14-P009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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