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The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental = Active rTMS | Active Comparator | Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks |
|
| Sham Comparator = Sham rTMS | Placebo Comparator | Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS | Device | Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patients:
Controls:
Exclusion Criteria:
Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Marion Plaze, MD, PhD | GHU Paris Psychiatry & Neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Antoine Hospital | Paris | 75012 | France | |||
| Centre Hospitalier Sainte-Anne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12239558 | Background | Blanke O, Ortigue S, Landis T, Seeck M. Stimulating illusory own-body perceptions. Nature. 2002 Sep 19;419(6904):269-70. doi: 10.1038/419269a. | |
| 22805909 | Background | Blanke O. Multisensory brain mechanisms of bodily self-consciousness. Nat Rev Neurosci. 2012 Jul 18;13(8):556-71. doi: 10.1038/nrn3292. |
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| ID | Term |
|---|---|
| D003861 | Depersonalization |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Placebo rTMS | Device | Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks |
|
|
| At 3 months after the treatment |
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) |
| Paris |
| 75014 |
| France |
| 10725532 | Background | Sierra M, Berrios GE. The Cambridge Depersonalization Scale: a new instrument for the measurement of depersonalization. Psychiatry Res. 2000 Mar 6;93(2):153-64. doi: 10.1016/s0165-1781(00)00100-1. |
| 17490989 | Background | Farrer C, Frey SH, Van Horn JD, Tunik E, Turk D, Inati S, Grafton ST. The angular gyrus computes action awareness representations. Cereb Cortex. 2008 Feb;18(2):254-61. doi: 10.1093/cercor/bhm050. Epub 2007 May 8. |
| 11205340 | Background | Frith CD, Blakemore SJ, Wolpert DM. Abnormalities in the awareness and control of action. Philos Trans R Soc Lond B Biol Sci. 2000 Dec 29;355(1404):1771-88. doi: 10.1098/rstb.2000.0734. |
| 20837362 | Background | Mantovani A, Simeon D, Urban N, Bulow P, Allart A, Lisanby S. Temporo-parietal junction stimulation in the treatment of depersonalization disorder. Psychiatry Res. 2011 Mar 30;186(1):138-40. doi: 10.1016/j.psychres.2010.08.022. Epub 2010 Sep 15. |
| 12680746 | Background | Sierra M, Phillips ML, Ivin G, Krystal J, David AS. A placebo-controlled, cross-over trial of lamotrigine in depersonalization disorder. J Psychopharmacol. 2003 Mar;17(1):103-5. doi: 10.1177/0269881103017001712. |
| 16164776 | Background | Sierra M, Baker D, Medford N, David AS. Unpacking the depersonalization syndrome: an exploratory factor analysis on the Cambridge Depersonalization Scale. Psychol Med. 2005 Oct;35(10):1523-32. doi: 10.1017/S0033291705005325. |
| 18088198 | Background | Sierra M. Depersonalization disorder: pharmacological approaches. Expert Rev Neurother. 2008 Jan;8(1):19-26. doi: 10.1586/14737175.8.1.19. |
| 21087873 | Background | Sierra M, David AS. Depersonalization: a selective impairment of self-awareness. Conscious Cogn. 2011 Mar;20(1):99-108. doi: 10.1016/j.concog.2010.10.018. Epub 2010 Nov 17. |
| 11058475 | Background | Simeon D, Guralnik O, Hazlett EA, Spiegel-Cohen J, Hollander E, Buchsbaum MS. Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000 Nov;157(11):1782-8. doi: 10.1176/appi.ajp.157.11.1782. |
| 17959254 | Background | Simeon D, Kozin DS, Segal K, Lerch B, Dujour R, Giesbrecht T. De-constructing depersonalization: further evidence for symptom clusters. Psychiatry Res. 2008 Jan 15;157(1-3):303-6. doi: 10.1016/j.psychres.2007.07.007. Epub 2007 Oct 23. |