Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).

Detailed Description
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This study is a research trial of an outpatient, non-medication, non-invasive investigational treatment called Transcranial Magnetic Stimulation (TMS). TMS applies a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30 minute-long daily sessions every weekday for a series of weeks. The investigators are testing whether TMS can treat Depersonalization Disorder (DPD). This is an open-label study. All patients will receive active treatment. DPD symptoms will be monitored through weekly self-report questionnaires as well clinical ratings with a doctor.

Official Title
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Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Conditions
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Depersonalization Disorder

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients, 18 to 70 years of age. Primary diagnosis of Depersonalization Disorder. Duration of the index episode of at least a year. Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and be to continue at the same dose(s) through the duration of the study. Capable and willing to provide informed consent Exclusion Criteria: Individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; cerebral aneurysm, Dementia; Parkinson's Disease; Huntington's chorea; Multiple Sclerosis. Increased risk of seizure for any reason, including prior head trauma with loss of consciousness for 5 minutes or more. 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. If participating in psychotherapy, must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial. Known or suspected pregnancy. Women who are breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Active rTMS<br>Active repetitive Transcranial Magnetic Stimulation (rTMS) | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Strong electromagnetic fields ( 2Tesla) generated briefly ( 1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.<br>* Other names: Magstim, Magstim Rapid, Magstim Rapid2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cambridge Depersonalization Scale (CDS) | Change on CDS from baseline. Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261 Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement. | 6, 9, or 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement (CGI-S) | Minimum CGI-S score: 1 Maximum CGI-S score: 7 Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement. Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3. = Normal, not at all ill = Borderline mentally ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill patients | 6, 9, or 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dissociative, Dissociation, Depersonalization, Depersonalization Disorder, Transcranial Magnetic Stimulation, TMS, Depersonalization Disorder (DPD), rTMS