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Completed

NCT Number: NCT02476435

Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

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

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Key information

Conditions

Depersonalization Disorder Behavior Behavioral Symptoms Depersonalization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sainte-Anne, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active rTMS

Device

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 rTMS

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: PERSONA

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2015
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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