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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Unknown status

Phase

Phase 1

Locations

Cuba

Study Type

Interventional

Intervention

Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Children, ADHD, rTMS, Safety

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

International Center for Neurological RestorationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial magnetic stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events

Secondary Outcome Measures

EEG changes in epileptiform or basal activity after treatment compared with the baseline

Full Information

NCT ID

NCT01052064

First Posted

January 18, 2010

Last Updated

January 19, 2010

Sponsor

International Center for Neurological Restoration, Cuba

1. Study Identification

Unique Protocol Identification Number

NCT01052064

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

International Center for Neurological Restoration, Cuba

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

Children, ADHD, rTMS, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transcranial magnetic stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial Magnetic Stimulation

Other Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation(rTMS)

Intervention Description

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)

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

week 1,during treatment

Secondary Outcome Measure Information:

Title

EEG changes in epileptiform or basal activity after treatment compared with the baseline

Time Frame

last day of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lázaro Gómez, MD

Phone

53 7 2715353

Ext

lazarog@neuro.ciren.cu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lázaro Gómez, MD

Organizational Affiliation

International Center of Neurological Restoration

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Center for Neurological Restoration

City

Havana

ZIP/Postal Code

11300

Country

Cuba

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lázaro Gómez, MD

Phone

53 7 2715353

Ext

lazarog@neuro.ciren.cu

First Name & Middle Initial & Last Name & Degree

Lázaro Gómez, MD

12. IPD Sharing Statement

Learn more about this trial

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

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