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Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil deep brain TMS in subjects with ADHD.
Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.
Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.
The study group will receive active dTMS treatment and the control group will receive an inactive, sham treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | deep TMS treatment |
|
| 2 | Sham Comparator | inactive treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBLPADD coil deep TMS | Device | 20 daily deep TMS treatment |
| |
| Sham |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| clinical improvement as measured using Clinical global Impression (CGI). | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yechiel Levkovitz, MD | Contact | 972-9-7478644 | ylevk@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| yechiel levkovitz, MD | Shalvata Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shalvata | Hod HaSharon | Israel |
|
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| Device |
inactive treatment |
|
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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