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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by International Center for Neurological Restoration, Cuba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
International Center for Neurological Restoration, Cuba
ClinicalTrials.gov Identifier:
NCT01052064
First received: January 18, 2010
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Device: Transcranial Magnetic Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapy With rTMS in Children With Attention Deficit and Hyperactivity Disorder. Phase 1 Study.

Resource links provided by NLM:


Further study details as provided by International Center for Neurological Restoration, Cuba:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: week 1,during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • EEG changes in epileptiform or basal activity after treatment compared with the baseline [ Time Frame: last day of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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)
Other Name: Repetitive Transcranial Magnetic Stimulation(rTMS)

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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052064

Contacts
Contact: Lázaro Gómez, MD 53 7 2715353 ext 50 lazarog@neuro.ciren.cu

Locations
Cuba
International Center for Neurological Restoration Recruiting
Havana, Cuba, 11300
Contact: Lázaro Gómez, MD    53 7 2715353 ext 50    lazarog@neuro.ciren.cu   
Principal Investigator: Lázaro Gómez, MD         
Sponsors and Collaborators
International Center for Neurological Restoration, Cuba
Investigators
Principal Investigator: Lázaro Gómez, MD International Center of Neurological Restoration
  More Information

No publications provided

Responsible Party: Lázaro Gómez Fernández, MD, International Center for Neurological Restoration
ClinicalTrials.gov Identifier: NCT01052064     History of Changes
Other Study ID Numbers: rTMS-09.01-ADHD
Study First Received: January 18, 2010
Last Updated: January 19, 2010
Health Authority: Cuba: Ministry of Public Health

Keywords provided by International Center for Neurological Restoration, Cuba:
Children
ADHD
rTMS
Safety

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014