Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults
| Tracking Information | |||||
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| First Received Date ICMJE | September 7, 2010 | ||||
| Last Updated Date | December 20, 2011 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Conners' Adult ADHD Rating Scale [ Time Frame: Screening, at the end of three weeks of treatment, and for each of two follow-up meetings ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01196910 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mindstreams Cognitive Tests [ Time Frame: Screening, at the end of three weeks of treatment, and for each of two follow-up meetings ] [ 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 | Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults | ||||
| Official Title ICMJE | Test Efficiency of Deep Transcranial Magnetic Stimulation (DTMS) Using an H-coil for Dorso-Lateral Prefrontal Cortex (HLPFC) to Treat Attention Deficit Hyperactivity Disorder (ADHD) in Adults | ||||
| Brief Summary | The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare this to the effect of sham DTMS on ADHD adults |
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| Detailed Description | Attention deficit disorder in adults may be due to hypoactivity of prefrontal areas of the brain. Increasing the activity of these areas may help improve symptoms in many of these patients. In addition there is evidence as to dysfunction in both hemispheres of the brain, but it is difficult to determine the contribution of each hemisphere's pattern of activity to behavioral impairment. The purpose of this study is to use high-frequency DTMS to stimulate activity either on the left side of the prefrontal cortex (one arm), or on the right side (a second arm), to see if such stimulation improves attention, comparing to sham DTMS simulation (a third arm). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE | Device: treatment by HLPFC coil
DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel). Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | 45 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2012 (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 | NCT01196910 | ||||
| Other Study ID Numbers ICMJE | IBR-0014-00 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Elissa Ash, Tel-Aviv Sourasky Medical Center | ||||
| Study Sponsor ICMJE | Brainsway | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Brainsway | ||||
| Verification Date | July 2011 | ||||
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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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