NCT00965211

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

3.3 years

First QC Date

August 24, 2009

Last Update Submit

January 4, 2012

Conditions

Tourette's SyndromeObsessive Compulsive Disorder

Keywords

Tourette's, OCD, dTMS, YGTSS, YBOCS, supplementary motor cortexTourette's syndrome and Obsessive compulsive disorder

Outcome Measures

Primary Outcomes (1)

  • The Yale Global Tic Severity rating Scale (YGTSS)

    At study entry and every 2 weeks since then. total of 4 evaluation

Secondary Outcomes (1)

  • Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS)

    At study entry and every 2 weeks since. A total of 4 evaluation

Interventions

HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)DEVICE

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.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shalvata Mental Health Center

Hod HaSharon, Israel

NOT YET RECRUITING

Shalvata Mental Health Center

Hod HaSharon, Israel

RECRUITING

MeSH Terms

Conditions

Tourette SyndromeObsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersAnxiety Disorders

Study Officials

  • Eiran Vadim Harel, MD

    Shalvata MHC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eiran Vadim Harel, MD

CONTACT

09-7478644eiranharel@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

IL(2)