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

NCT ID: NCT01052064

Last Updated: 2010-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-04-30

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

Repetitive Transcranial Magnetic Stimulation(rTMS)

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Center for Neurological Restoration, Cuba

OTHER

Sponsor Role: lead

Responsible Party

International Center for Neurological Restoration

Principal Investigators

Lázaro Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

International Center of Neurological Restoration

Locations

International Center for Neurological Restoration

Havana, La Habana, Cuba

Site Status: RECRUITING

Countries

Cuba

Central Contacts

Lázaro Gómez, MD

Role: CONTACT

lazarog@neuro.ciren.cu

53 7 2715353 ext. 50

Facility Contacts

Lázaro Gómez, MD

Role: primary

lazarog@neuro.ciren.cu

53 7 2715353 ext. 50

Other Identifiers

rTMS-09.01-ADHD

Identifier Type: -

Identifier Source: org_study_id