NCT02290899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2017

Completed
Last Updated

August 10, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

November 11, 2014

Last Update Submit

August 8, 2017

Conditions

ADHD

Keywords

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

  • Stop-Signal Task

    Immediately following tDCS

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients with ADHD

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradley Hospital

East Providence, Rhode Island, 02915, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 14, 2014

Study Start

June 1, 2014

Primary Completion

August 7, 2017

Study Completion

August 7, 2017

Last Updated

August 10, 2017

Record last verified: 2017-04

Locations

US(1)