NCT02476435 - Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation | Crick

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

81

Conditions

Depersonalization Disorder

Interventions

Active rTMSDEVICE

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

Placebo rTMSDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Saint-Antoine Hospital

Paris, France

Centre Hospitalier Sainte-Anne

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes