Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

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

Detailed Description
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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.

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

Conditions
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Depersonalization Disorder

Intervention / Treatment
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* Device: Active rTMS
* Device: Placebo rTMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental = Active rTMS<br>Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks | Device: Active rTMS<br>* Strong electromagnetic fields ( 2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks<br>* 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<br>Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks | Device: Placebo rTMS<br>* Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks<br>* Other names: Magstim Super-Rapid2, Neuronavigation system Visor (ANT);|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial magnetic stimulation, Angular gyrus, Temporo-parietal junction, Depersonalization, Derealization, Embodiment, Emotional numbing