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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01052064
• Other study ID #: rTMS-09.01-ADHD
• Status: Recruiting
• Phase: Phase 1
• First received: January 18, 2010
• Last updated: January 19, 2010
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2010
• Source: International Center for Neurological Restoration, Cuba
• Contact: Lázaro Gómez, MD
• Phone: 53 7 2715353
• Email: lazarog[@]neuro.ciren.cu
• Is FDA regulated: No
• Health authority: Cuba: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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)

Locations

Country	Name	City	State
Cuba	International Center for Neurological Restoration	Havana

Sponsors (1)

Lead Sponsor	Collaborator
International Center for Neurological Restoration, Cuba

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		week 1,during treatment	Yes
Secondary	EEG changes in epileptiform or basal activity after treatment compared with the baseline		last day of treatment	Yes