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

Phase 1

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT01052064
• Lead Sponsor: International Center for Neurological Restoration, Cuba

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.

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.

Study Timeline

• Study Start: 2009-04
• Status Verified: 2010-01
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-19
• Last Update Submitted: 2010-01-19
• Study First Posted: 2010-01-20
• Last Update Posted: 2010-01-20
• Primary Completion: 2010-03
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	week 1,during treatment

Secondary Outcome Measures

Name	Time	Method
EEG changes in epileptiform or basal activity after treatment compared with the baseline	last day of treatment

Trial Locations

Locations (1)

International Center for Neurological Restoration; 🇨🇺 Havana, Cuba