Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation
NCT ID: NCT02476435
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2015-06-19
2022-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental = Active rTMS
Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Active rTMS
Strong electromagnetic fields (\~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Sham Comparator = Sham rTMS
Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Placebo rTMS
Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks
Interventions
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Active rTMS
Strong electromagnetic fields (\~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Placebo rTMS
Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Marion Plaze, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
GHU Paris Psychiatry & Neurosciences
Locations
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Saint-Antoine Hospital
Paris, , France
Centre Hospitalier Sainte-Anne
Paris, , France
Countries
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References
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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.
Blanke O. Multisensory brain mechanisms of bodily self-consciousness. Nat Rev Neurosci. 2012 Jul 18;13(8):556-71. doi: 10.1038/nrn3292.
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.
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.
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.
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.
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.
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.
Sierra M. Depersonalization disorder: pharmacological approaches. Expert Rev Neurother. 2008 Jan;8(1):19-26. doi: 10.1586/14737175.8.1.19.
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.
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.
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.
Other Identifiers
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D14-P009
Identifier Type: -
Identifier Source: org_study_id
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