CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Active Neurofeedback +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00886483
NCT00886483N/ACompleted
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Pilot Explorations of Neurofeedback Issues in ADHD

L. Eugene Arnold·interventional·Posted Apr 23, 2009·Updated Nov 11, 2016

In Brief

A clinical study evaluating Active Neurofeedback and Sham neurofeedback for Attention Deficit Hyperactivity Disorder. Completed, enrolled 39 participants across 1 site.

Detailed Summary

Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base. The numerous open and partially controlled studies suffer serious design flaws. In particular, there is no published double-blind randomized clinical trial (RCT), which would control for experimenter and participant biases. The primary aim of this R34 pilot study is to conduct a small-scale pilot with 39 8-12 year-olds with ADHD to prepare for such a larger RCT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Brain Resource Center

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 23, 2009
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.2 years ago

Interventions

Active Neurofeedbackdevice

A comparison of active neurofeedback to sham neurofeedback and of two treatment schedules: twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.

Sham neurofeedbackdevice

Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.