Clinical trial NCT02476435: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation
Official title: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depersonalization Disorder
Keywords: Depersonalization
Derealization
Embodiment
Emotional numbing
Transcranial magnetic stimulation
Angular gyrus
Temporo-parietal junction
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cambridge Depersonalization Scale (CDS)
timeFrame: At 3 weeks (in the end of the treatment)
measure: Cambridge Depersonalization Scale (CDS)
timeFrame: At 1 month after the treatment
measure: Cambridge Depersonalization Scale (CDS)
timeFrame: At 2 months after the treatment
measure: Cambridge Depersonalization Scale (CDS)
timeFrame: At 3 months after the treatment
Secondary outcomes:
measure: Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS
timeFrame: At 3 months
measure: Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
timeFrame: Baseline
measure: Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
timeFrame: Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS)
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint-Antoine Hospital
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
Study officials:
affiliation: GHU Paris Psychiatry & Neurosciences
name: Marion Plaze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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