Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by International Center for Neurological Restoration, Cuba.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
International Center for Neurological Restoration, Cuba
Information provided by:
International Center for Neurological Restoration, Cuba
ClinicalTrials.gov Identifier:
NCT01052064
First received: January 18, 2010
Last updated: January 19, 2010
Last verified: January 2010
| Tracking Information | |||||
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| First Received Date ICMJE | January 18, 2010 | ||||
| Last Updated Date | January 19, 2010 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of adverse events [ Time Frame: week 1,during treatment ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01052064 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
EEG changes in epileptiform or basal activity after treatment compared with the baseline [ Time Frame: last day of treatment ] [ Designated as safety issue: Yes ] | ||||
| 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 | Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study | ||||
| Official Title ICMJE | Therapy With rTMS in Children With Attention Deficit and Hyperactivity Disorder. Phase 1 Study. | ||||
| Brief Summary | Low frequency repetitive Transcranial Magnetic Stimulation(rTMS) is a safe and tolerable procedure in children with Attention Deficit Hyperactivity Disorder(ADHD); it also could be a complement to the treatment of patients with poor symptomatic control to conventional treatment. |
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| Detailed Description | Attention Deficit Hyperactivity Disorder is a common disorder in the infancy; the majority of ADHD have good clinical response to amphetamines alone or in association with antiepileptic drugs. It is described that some patients(10-30%) with ADHD do not respond to conventional pharmacological and psycho- pedagogical treatment; in those patients non invasive brain stimulation methods could be a supplementary option for symptomatic control. There are not many published papers describing the effects of rTMS in persons younger than 18 years; so the first step to extent its use in pediatric population should be to obtain evidences about its tolerance and safety. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE | Device: Transcranial Magnetic Stimulation
rTMS will be administered in one daily session during 5 consecutive days of 1 Hz, 90% of motor threshold for a total of 1500 stimuli. The stimulation will be focal over left dorsolateral-prefrontal cortex(F3, from the international 10-20 system)
Other Name: Repetitive Transcranial Magnetic Stimulation(rTMS) |
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| Study Arm (s) | Experimental: Transcranial magnetic stimulation
There are evidences that rTMS has a modulating effect in cortical and subcortical neural networks, reinforcing or depressing synaptic activity by mean of long term potentiation or depression like mechanism. Depression is the most study neuropsychiatric condition in which rTMS is useful as a therapeutic option; but in other diseases such as ADHD there are many pathophysiological elements that make it very likely that rTMS could be useful for symptomatic treatment modulating activity in prefrontal and basal ganglia neuronal networks.
Intervention: Device: Transcranial Magnetic Stimulation |
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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 | 20 | ||||
| Estimated Completion Date | April 2010 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Cuba | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01052064 | ||||
| Other Study ID Numbers ICMJE | rTMS-09.01-ADHD | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lázaro Gómez Fernández, MD, International Center for Neurological Restoration | ||||
| Study Sponsor ICMJE | International Center for Neurological Restoration, Cuba | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | International Center for Neurological Restoration, Cuba | ||||
| Verification Date | January 2010 | ||||
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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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