A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.
NCT01723319 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2012-11-07
Summary
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
Conditions
- ADHD
Interventions
- DEVICE
-
HBLPADD coil deep TMS
20 daily deep TMS treatment
- DEVICE
-
Sham
inactive treatment
Sponsors & Collaborators
-
Shalvata Mental Health Center
lead OTHER
Principal Investigators
-
yechiel levkovitz, MD · Shalvata Mental Health Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2013-05-31
Countries
- Israel
Study Locations
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