Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapy With rTMS in Children With Attention Deficit and Hyperactivity Disorder. Phase 1 Study.

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages eligible for Study: 7years to 12 years Genders Eligible for Study: Both Exclusion Criteria: History of convulsions Co-morbidity with other psychiatric or neurologic disease

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial magnetic stimulation<br>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. | Device: Transcranial Magnetic Stimulation<br>* 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)<br>* Other names: Repetitive Transcranial Magnetic Stimulation(rTMS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | week 1,during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG changes in epileptiform or basal activity after treatment compared with the baseline |  | last day of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, ADHD, rTMS, Safety