Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder

ADHD Clinical Trial

Official title:

Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290899
• Other study ID #: 4067-14
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: August 8, 2017
• Start date: June 2014
• Est. completion date: August 7, 2017

Study information

• Verified date: April 2017
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Locations

Country	Name	City	State
United States	Bradley Hospital	East Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Rhode Island Hospital	Bradley Hospital, Nancy Lurie Marks Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stop-Signal Task		Immediately following tDCS