Therapy With rTMS in Children With Attention Deficit and Hyperactivity Disorder. Phase 1 Study.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- International Center for Neurological Restoration, Cuba
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: week 1,during treatment
Secondary Outcomes
- EEG changes in epileptiform or basal activity after treatment compared with the baseline(last day of treatment)