Tourette's SyndromeNCT00965211
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome
A study testing HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS) in people with Tourette's Syndrome and Obsessive Compulsive Disorder, run by Shalvata Mental Health Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tourette's Syndrome, Obsessive Compulsive Disorder
- What is being tested?
- HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2009to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Shalvata Mental Health Center
Hod HaSharon
Eiran
Eiran Vadim Harel, MD
- Recruiting
Shalvata Mental Health Center
Hod HaSharon
Hilik Levkovitz, prof., 972-9-7478568, ylevk@clalit.org.il
About this study
Official title: Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome.
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.
Read the 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.
- Conditions
- Tourette's Syndrome, Obsessive Compulsive Disorder
- Being tested
- HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
- Keywords
- Tourette's, OCD, dTMS, YGTSS, YBOCS, supplementary motor cortex, Tourette's syndrome and Obsessive compulsive disorder
- Medical subject headings
- Tourette Syndrome, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Yale Global Tic Severity rating Scale (YGTSS)
Measured: At study entry and every 2 weeks since then. total of 4 evaluation
Secondary outcomes (1)
Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS)
Measured: At study entry and every 2 weeks since. A total of 4 evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eiran Vadim Harel, MD, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965211
- Sponsor's protocol ID
- TMS HBDL
- Status last verified
- Jan 2012
- First submitted
- 24 Aug 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome.
- ClinicalTrials.gov ID
- NCT00965211
- Acronym / sponsor ID
- TMS HBDL
- Conditions
- Tourette's Syndrome, Obsessive Compulsive Disorder
- Keywords
- Tourette's, OCD, dTMS, YGTSS, YBOCS, supplementary motor cortex, Tourette's syndrome and Obsessive compulsive disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
The Yale Global Tic Severity rating Scale (YGTSS)
Time frame: At study entry and every 2 weeks since then. total of 4 evaluation
1 secondary outcome
Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS)
Time frame: At study entry and every 2 weeks since. A total of 4 evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eiran Vadim Harel, MD principal investigator
Shalvata MHC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS) in people with Tourette's Syndrome and Obsessive Compulsive Disorder, run by Shalvata Mental Health Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eiran Vadim Harel, MD (09-7478644 ext. 972, eiranharel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Yale Global Tic Severity rating Scale (YGTSS) (time frame: At study entry and every 2 weeks since then. total of 4 evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.