Ignite Creation Date:
2024-05-05 @ 9:47 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00965211
Status:
UNKNOWN
Last Update Posted:
2012-01-05
First Post:
2009-08-24
Brief Title:
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome
Status:
UNKNOWN
Status Verified Date:
2012-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open studyapproximately 20 patients diagnosed with tourettes syndrome and under pharmAcological or psychotherapy treatments will participatepatients 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 weeksand 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
We anticipate a significant reduction in symptoms severity at the end of the treatment compared to study entry
Detailed Description:
Tourettes 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 stimulationdTMS technologyour 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 monthswe are using a similar protocol of TMS stimulation used in a study by Mantovani et al 2006The 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 recessapproximately 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
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 stimulationdTMS technologyour 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 monthswe are using a similar protocol of TMS stimulation used in a study by Mantovani et al 2006The 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 recessapproximately 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None