Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

Not Applicable

Completed

• Conditions: Depersonalization Disorder
• Interventions: Device: Placebo rTMS; Device: Active rTMS

• Registration Number: NCT02476435
• Lead Sponsor: Centre Hospitalier St Anne

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-18
• Study Start: 2015-06-19
• Study First Posted: 2015-06-19
• Status Verified: 2017-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator = Sham rTMS	Placebo rTMS	Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Experimental = Active rTMS	Active rTMS	Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks

Primary Outcome Measures

Name	Time	Method
Cambridge Depersonalization Scale (CDS)	At 3 months after the treatment	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

Secondary Outcome Measures

Name	Time	Method
Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS	At 3 months	maintenance of reduction of at least 50% of the original score to the depersonalization scale of Cambridge.
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)	Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.

Trial Locations

Locations (2)

Saint-Antoine Hospital; 🇫🇷 Paris, France

Centre Hospitalier Sainte-Anne; 🇫🇷 Paris, France