Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

NCT02476435 | Completed

• 1 other identifier: D14-P009
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Depersonalization Disorder

Keywords

Depersonalization; Derealization; Embodiment; Emotional numbing; Transcranial magnetic stimulation; Angular gyrus; Temporo-parietal junction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS

  At 3 months

• Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity

  Baseline

• Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity

  Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS)

Study Arms (2)

Experimental = Active rTMS

ACTIVE COMPARATOR

Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks

Device: Active rTMS

Sham Comparator = Sham rTMS

PLACEBO COMPARATOR

Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks

Device: Placebo rTMS

Interventions

Active rTMS DEVICE

Strong electromagnetic fields (\~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks

Also known as: Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks

Experimental = Active rTMS

Placebo rTMS DEVICE

Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks

Also known as: Magstim Super-Rapid2, Neuronavigation system Visor (ANT)

Sham Comparator = Sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (2)

Saint-Antoine Hospital

Paris, 75012, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Related 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.

  PMID: 12239558 BACKGROUND

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

  PMID: 22805909 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.

  PMID: 10725532 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.

  PMID: 17490989 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.

  PMID: 11205340 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.

  PMID: 20837362 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.

  PMID: 12680746 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.

  PMID: 16164776 BACKGROUND

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

  PMID: 18088198 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.

  PMID: 21087873 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.

  PMID: 11058475 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.

  PMID: 17959254 BACKGROUND

MeSH Terms

Conditions

Depersonalization

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Marion Plaze, MD, PhD

  GHU Paris Psychiatry & Neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 19, 2015
• Study Start: June 19, 2015
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 1, 2023

Record last verified: 2017-10

Locations

FR (2)