A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.
NCT ID: NCT01723319
Last Updated: 2012-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2012-11-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
deep TMS treatment
HBLPADD coil deep TMS
20 daily deep TMS treatment
2
inactive treatment
Sham
inactive treatment
Interventions
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HBLPADD coil deep TMS
20 daily deep TMS treatment
Sham
inactive treatment
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV.
3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
4. Gave informed consent for participation in the study.
5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study.
Exclusion Criteria
2. antipsychotic treatment with stabilizers; medications from the Benzodiazepines group are allowed, if need be,to a maximum dosage of 2 mg lorazepam.
3. History of lack of tolerance to TMS.
4. Axis 2 diagnosis according to the DSM IV.
5. Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
6. Attempted suicide in the past year.
7. High and not controlled blood pressure.
8. History of epilepsy, seizure, or hot spasm.
9. History of epilepsy or seizure in first degree relatives.
10. History of a significant head injury
11. History of metal in the head (outside the mouth space).
12. Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
13. Use of hearing aids for hearing loss.
14. History of frequent or severe headaches.
15. History of drug or alcohol abuse during the last year.
16. Inability to achieve satisfying level of communication with the subject.
17. Participation in current clinical study or clinical study within 30 days prior to this study
18. Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
19. Women - Pregnancy or not using a reliable method of birth control.
18 Years
65 Years
ALL
No
Sponsors
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Shalvata Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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yechiel levkovitz, MD
Role: PRINCIPAL_INVESTIGATOR
Shalvata Mental Health Center
Locations
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Shalvata
Hod HaSharon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Yechiel levkovitz, MD
Role: primary
Other Identifiers
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SH-0025-12
Identifier Type: -
Identifier Source: org_study_id