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Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation (PERSONA)
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Purpose
| Condition | Intervention |
|---|---|
| Depersonalization Disorder | Device: Active rTMS Device: Placebo rTMS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus. |
- Cambridge Depersonalization Scale (CDS) [ Time Frame: At 3 weeks (in the end of 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
- Cambridge Depersonalization Scale (CDS) [ Time Frame: At 1 month 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
- Cambridge Depersonalization Scale (CDS) [ Time Frame: At 2 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
- Cambridge Depersonalization Scale (CDS) [ Time Frame: 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
- Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS [ Time Frame: 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 [ Time Frame: Baseline ]Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
- Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity [ Time Frame: 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.
| Estimated Enrollment: | 102 |
| Study Start Date: | June 2015 |
| Estimated Study Completion Date: | September 2019 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Experimental = Active rTMS
Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
|
Device: Active rTMS
Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Other Name: Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
|
|
Placebo Comparator: Sham Comparator = Sham rTMS
Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
|
Device: Placebo rTMS
Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks
Other Name: Magstim Super-Rapid2, Neuronavigation system Visor (ANT)
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02476435
| Contact: Marion PLAZE, MD, PhD | 00 33 1 45 65 76 65 | m.plaze@ch-sainte-anne.fr | |
| Contact: Marie GODARD | 00 33 1 45 65 77 28 | marie.godard@aphp.fr |
| France | |
| Saint-Antoine Hospital | Not yet recruiting |
| Paris, France, 75012 | |
| Contact: Stéphane MOUCHABAC, MD stephane.mouchabac@aphp.fr | |
| Centre Hospitalier Sainte-Anne | Recruiting |
| Paris, France, 75014 | |
| Contact: Marion PLAZE, MD, PhD m.plaze@ch-sainte-anne.fr | |
More Information
Publications:
| Responsible Party: | Centre Hospitalier St Anne |
| ClinicalTrials.gov Identifier: | NCT02476435 History of Changes |
| Other Study ID Numbers: |
D14-P009 |
| Study First Received: | June 11, 2015 |
| Last Updated: | February 11, 2016 |
Keywords provided by Centre Hospitalier St Anne:
|
Depersonalization Derealization Embodiment Emotional numbing |
Transcranial magnetic stimulation Angular gyrus Temporo-parietal junction |
Additional relevant MeSH terms:
|
Disease Depersonalization Pathologic Processes Behavioral Symptoms |
ClinicalTrials.gov processed this record on July 13, 2017