Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00965211
First received: August 24, 2009
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

This is an open study.approximately 20 patients diagnosed with tourette's syndrome and under pharmAcological or psychotherapy treatments will participate.patients will be recruited from Schneider hospital and all his extensions. subjects would undergo rTMS (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks,and will be clinically evaluated in order to monitor for improvement.

We anticipate a significant reduction in symptoms severity at the end of the treatment compared to study entry.


Condition Intervention
Tourette's Syndrome
Obsessive Compulsive Disorder
Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome.

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • The Yale Global Tic Severity rating Scale (YGTSS) [ Time Frame: At study entry and every 2 weeks since then. total of 4 evaluation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) [ Time Frame: At study entry and every 2 weeks since. A total of 4 evaluation ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
    a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 1 Hz to the supplementary motor cortex and then a 2 minute recess.each subject would undergo 5 sessions a week for 4 weeks.
Detailed Description:

Tourette's syndrome is a developmental neuropsychiatric disorder which is characterized by stereotypical motor and verbal bursts that are called Tics.

There is a small number of treatments that are available for the disorder, most of them are pharmacological agents that have serious side effects and are not very efficient in treating it.

In this current study we are attempting to find a better solution for the treatment of tourette syndrome using deep Transcranial magnetic stimulation(dTMS) technology.our region of interest for stimulation is the supplementary motor cortex (SMA). earlier superficial TMS studies focusing on the SMA have shown promising results. In theses studies clinical improvement was evident after two weeks of treatment, and for some of the subjects it was even maintained for a period of 3 months.we are using a similar protocol of TMS stimulation used in a study by Mantovani et al (2006).The protocol includes bilateral stimulation to the SMA at 110% of the motor threshold of the Abductor Policies Brevis and at a frequency of 1 Hz. each session is comprised of four cycles of 5 minutes of stimulation and a 2 minute recess.approximately 20 patients diagnosed with tourette syndrome and under pharmAcological or psychotherapy treatments will participate. patients will be recruited from Shnider hospital and all his extensions subjects would undergo rTMS sessions for five days a week, for four weeks, using the HBDL dTMS coil. this coil is capable of producing a magnetic field in deeper parts of the cerebral cortex, and for that reason we believe that it can produce better clinical outcomes then superficial TMS coils (such as the figure 8) used in past studies.

Clinical evaluation includes Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) , Yale Global Tic Severity rating Scale (YGTSS), Clinical Global Impression (CGI), Beck Depression Inventory (BDI), Symptoms Check List (SCL-90), Social Adaptation Self evaluation Scale (SASS), Hamilton Depression Rating Scale (HDRS-24), Hamilton Anxiety Rating Scale (HARS-14), Beck Depression Inventory (BDI) .These evaluation will be conducted on study entry, 2 weeks after study entry, at the end of the treatment phase and at a 2 week follow up visit (a total of four times). Further more, clinical evaluation will be administrated at Schneider hospital, while treatments are conducted at the cognitive lab at Shalvata hospital.

Our main objective is to observe a reduction in the severity of the symptoms post treatment in comparison to pre treatment, using the YGTSS as the main outcome measure.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and woman between the ages of 18-55
  • Diagnosed as suffering from tourette's syndrome according to the DSM IV, as determined by a senior psychiatrist on the basis of the Structured Clinical Interview for DSM-IV Axis I
  • pharmocological treatment stays constant for the duration of the study
  • Gave informed consent for participation in the study

Exclusion Criteria:

  • Electroconvulsive therapy (ECT) less than 9 months prior to screening.
  • Attempted suicide in the past year.
  • History of seizure or heat convulsion.
  • History of epilepsy or seizure in first degree relatives.
  • History of head injury.
  • History of any metal in the head (outside the mouth).
  • Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
  • History of frequent or severe headaches.
  • History of migraine.
  • History of hearing loss.
  • Known history of cochlear implants
  • Pregnancy or not using a reliable method of birth control.
  • Inadequate communication with the patient.
  • Under custodial care.
  • Participation in current clinical study or clinical study within 30 days prior to this study.
  • A significant physical illness which is not balanced.
  • an addiction to psychoactive drugs in the last year or psychoactive substance abuse in the last month without addiction.
  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: NCT00965211

Contacts
Contact: Eiran Vadim Harel, MD 09-7478644 ext 972 eiranharel@yahoo.com

Locations
Israel
Shalvata Mental Health Center Not yet recruiting
Hod Hasharon, Israel
Contact: Eiran         
Principal Investigator: Eiran Vadim Harel, MD         
Shalvata Mental Health Center Recruiting
Hod Hasharon, Israel
Contact: Hilik Levkovitz, prof.    972-9-7478568    ylevk@clalit.org.il   
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Eiran Vadim Harel, MD Shalvata MHC
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00965211     History of Changes
Other Study ID Numbers: TMS HBDL
Study First Received: August 24, 2009
Last Updated: January 4, 2012
Health Authority: Israel: ministery of health

Keywords provided by Shalvata Mental Health Center:
Tourette's, OCD, dTMS, YGTSS, YBOCS, supplementary motor cortex
Tourette's syndrome and Obsessive compulsive disorder

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Syndrome
Tourette Syndrome
Anxiety Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Disease
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Personality Disorders
Tic Disorders

ClinicalTrials.gov processed this record on October 22, 2014