Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With Attention-Deficit Hyperactivity Disorder (ADHD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Shalvata Mental Health Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shalvata Mental Health Center
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00825708
First received: January 19, 2009
Last updated: January 20, 2009
Last verified: January 2009
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2009 | ||||
| Last Updated Date | January 20, 2009 | ||||
| Start Date ICMJE | March 2007 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PANNAS questionnaire modified for attention [ Time Frame: within one hour of the rTMS session ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00825708 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
the CANTAB neurocognitive battery [ Time Frame: within 2 hours of the stimulation ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With Attention-Deficit Hyperactivity Disorder (ADHD) | ||||
| Official Title ICMJE | Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With ADHD | ||||
| Brief Summary | The aim of the study is to evaluate the immediate effect of rTMS on attention in adults diagnosed with ADHD. the design is a double blind sham controlled crossover study. |
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| Detailed Description | The subjects were randomly assigned to two groups. group 1 starts with the real rTMS session followed within one week with a sham session. group 2 starts with a sham session and within one week recieve a real session. the subjects go through a neurocognitive evaluation before and after rTMS sessions and a clinical evaluation questionnaire modified for attention. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Bloch Y, Harel EV, Aviram S, Govezensky J, Ratzoni G, Levkovitz Y. Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. World J Biol Psychiatry. 2010 Aug;11(5):755-8. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00825708 | ||||
| Other Study ID Numbers ICMJE | SH20107, SH20107 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Yuval Bloch, shalvataMHC | ||||
| Study Sponsor ICMJE | Shalvata Mental Health Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Shalvata Mental Health Center | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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