Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation (PERSONA)

Centre Hospitalier St Anne

Status: Completed

Conditions: Depersonalization Disorder

Treatments: Device: Active rTMS; Device: Placebo rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02476435

D14-P009

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

Experimental = Active rTMS

Active Comparator group

Description:

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

Treatment:

Device: Active rTMS

Sham Comparator = Sham rTMS

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo rTMS