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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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.
    


Study Type

Interventional


Primary Outcome

The Yale Global Tic Severity rating Scale (YGTSS)

Secondary Outcome

 Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS)

Condition

Tourette's Syndrome

Intervention

HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

September 2009

Completion Date

January 2013

Primary Completion Date

January 2013

Eligibility 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.
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Eiran Vadim Harel, MD, 09-7478644, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00965211

Organization ID

TMS HBDL


Responsible Party

Sponsor

Study Sponsor

Shalvata Mental Health Center


Study Sponsor

Eiran Vadim Harel, MD, Principal Investigator, Shalvata MHC


Verification Date

January 2012