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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052064

Enrollment

Registered

2010-01-20

Start date

2009-04-30

Completion date

2010-04-30

Last updated

2010-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Children, ADHD, rTMS, Safety

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.

Interventions

DEVICETranscranial 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)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	week 1,during treatment

Secondary

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

Countries

Cuba

Contacts

Primary ContactLázaro Gómez, MD

lazarog@neuro.ciren.cu53 7 2715353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026