Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

Depersonalization Disorder Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476435
• Other study ID #: D14-P009
• Status: Completed
• Phase: N/A
• Start date: June 19, 2015
• Est. completion date: October 10, 2022

Study information

• Verified date: October 2017
• Source: Centre Hospitalier St Anne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depersonalization
• Depersonalization Disorder

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Sainte-Anne	Paris
France	Saint-Antoine Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

References & Publications (12)

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. — View Citation

Blanke O. Multisensory brain mechanisms of bodily self-consciousness. Nat Rev Neurosci. 2012 Jul 18;13(8):556-71. doi: 10.1038/nrn3292. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sierra M. Depersonalization disorder: pharmacological approaches. Expert Rev Neurother. 2008 Jan;8(1):19-26. doi: 10.1586/14737175.8.1.19. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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)