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Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT02290899
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : August 10, 2017
Sponsor:
Collaborators:
Nancy Lurie Marks Family Foundation
Bradley Hospital
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:
The main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Research suggest that this procedure leads to improvement in brain and behavioral measures of inhibitory control (controlling impulses) in healthy control participants. The investigators want to explore whether the same improvement will be seen in kids with ADHD.

Condition or disease
ADHD

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Official Title: Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder
Study Start Date : June 2014
Actual Primary Completion Date : August 7, 2017
Actual Study Completion Date : August 7, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Stop-Signal Task [ Time Frame: Immediately following tDCS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ADHD
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ADHD
  • Parent informed consent and child assent

Exclusion Criteria:

  • Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis Type 1 (NF1), tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
  • History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
  • Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • History of head injury resulting in prolonged loss of consciousness
  • Substance abuse or dependence within the past six months
  • Chronic treatment with prescription medications that decrease cortical seizure threshold that the patient is unable to withhold from taking during study visits
  • Damaged skin on the scalp (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290899


Locations
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United States, Rhode Island
Bradley Hospital
East Providence, Rhode Island, United States, 02915
Sponsors and Collaborators
Rhode Island Hospital
Nancy Lurie Marks Family Foundation
Bradley Hospital
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02290899    
Other Study ID Numbers: 4067-14
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: April 2017
Keywords provided by Rhode Island Hospital:
Attention Deficit Hyperactivity Disorder (ADHD)
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases