Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study
Therapy With rTMS in Children With Attention Deficit and Hyperactivity Disorder. Phase 1 Study.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 18, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJanuary 20, 2010
January 1, 2010
11 months
January 18, 2010
January 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
week 1,during treatment
Secondary Outcomes (1)
EEG changes in epileptiform or basal activity after treatment compared with the baseline
last day of treatment
Study Arms (1)
Transcranial magnetic stimulation
EXPERIMENTALThere 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Ages eligible for Study: 7years to 12 years
- Genders Eligible for Study: Both
You may not qualify if:
- History of convulsions
- Co-morbidity with other psychiatric or neurologic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Center for Neurological Restoration
Havana, La Habana, 11300, Cuba
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lázaro Gómez, MD
International Center of Neurological Restoration
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 18, 2010
First Posted
January 20, 2010
Study Start
April 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
January 20, 2010
Record last verified: 2010-01