Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS) - Full Text View

Purpose

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

Condition	Intervention	Phase
Depersonalization Disorder	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Depersonalization Disorder

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

Cambridge Depersonalization Scale (CDS) [ Time Frame: 6, 9, or 12 weeks ]
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.

Secondary Outcome Measures:

Clinical Improvement (CGI-S) [ Time Frame: 6, 9, or 12 weeks ]
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.
1. = Normal, not at all ill
2. = Borderline mentally ill
3. = Mildly ill
4. = Moderately ill
5. = Markedly ill
6. = Severely ill
7. = Among the most extremely ill patients


Enrollment:	10
Study Start Date:	May 2006
Study Completion Date:	October 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Open-Label Active rTMS Active repetitive Transcranial Magnetic Stimulation (rTMS)	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks. Other Name: Magstim, Magstim Rapid, Magstim Rapid2

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529217

Locations


United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators


Principal Investigator:	Antonio Mantovani, MD	Columbia

More Information

Additional Information:

Division of Brain Stimulation and Therapeutic Modulation web site This link exits the ClinicalTrials.gov site

Publications:

Blanke O, Mohr C, Michel CM, Pascual-Leone A, Brugger P, Seeck M, Landis T, Thut G. Linking out-of-body experience and self processing to mental own-body imagery at the temporoparietal junction. J Neurosci. 2005 Jan 19;25(3):550-7.

Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403.

Hunter EC, Baker D, Phillips ML, Sierra M, David AS. Cognitive-behaviour therapy for depersonalisation disorder: an open study. Behav Res Ther. 2005 Sep;43(9):1121-30.

Jiménez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6.

Sierra M, Phillips ML, Ivin G, Krystal J, David AS. A placebo-controlled, cross-over trial of lamotrigine in depersonalization disorder. J Psychopharmacol. 2003 Mar;17(1):103-5.

Simeon D, Guralnik O, Hazlett EA, Spiegel-Cohen J, Hollander E, Buchsbaum MS. Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000 Nov;157(11):1782-8.

Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6.

Simeon D, Knutelska M. An open trial of naltrexone in the treatment of depersonalization disorder. J Clin Psychopharmacol. 2005 Jun;25(3):267-70.

Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. Review.

Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16.


Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00529217 History of Changes
Other Study ID Numbers:	5269
Study First Received:	September 13, 2007
Results First Received:	December 13, 2012
Last Updated:	September 16, 2014

Keywords provided by New York State Psychiatric Institute:


Dissociative Dissociation Depersonalization Depersonalization Disorder	Transcranial Magnetic Stimulation TMS Depersonalization Disorder (DPD) rTMS

Additional relevant MeSH terms:


Disease Depersonalization Pathologic Processes Behavioral Symptoms

ClinicalTrials.gov processed this record on July 13, 2017

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