Trial Outcomes & Findings for Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00886483)

Results Overview

The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

2 years

Results posted on

2016-11-11

Participant Flow

Dates of recruitment: August 2008 to December 2009. Location: Nisonger Center, OSU Medical Center

Exclusion criteria: IQ \<80, mental age \<6, comorbid disorder or a medical disorder requiring medication that had psychoactive effects, \>5 previous NF treatments, antipsychotic medication within 6 mths pre-baseline, fluoxetine/atomoxetine 4-wks pre-baseline, stimulant 1-wk pre-baseline, or any other psychotropic medication 2-wks pre-baseline.

Participant milestones

Participant milestones
Measure	Active Neurofeedback In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Overall Study STARTED	26	13
Overall Study Completed 20 Treatments	25	11
Overall Study COMPLETED	24	10
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Neurofeedback In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Overall Study Lost to Follow-up	0	1
Overall Study Pursue medications	1	2
Overall Study Distance to center, poor grades	1	0

Baseline Characteristics

Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Neurofeedback n=26 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=13 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	26 Participants n=5 Participants	13 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.0 years STANDARD_DEVIATION 1.5 • n=5 Participants	8.7 years STANDARD_DEVIATION 2.1 • n=7 Participants	8.9 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	4 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	13 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Based on inclusion \& exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.

The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.

Outcome measures

Outcome measures
Measure	Neurofeedback n=26 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=13 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number	26 participants	13 participants

PRIMARY outcome

Timeframe: 40th treatment sessions ~ 13-20 weeks

Population: Number randomized was denominator for percentage of participants completing 40 treatment sessions.

The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).

Outcome measures

Outcome measures
Measure	Neurofeedback n=26 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=13 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Feasibility of Double-blind, Sham-controlled Design #2. Retention	92.3 percentage of participants	76.9 percentage of participants

PRIMARY outcome

Timeframe: Post-treatment at session 40

Population: Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.

The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.

Outcome measures

Outcome measures
Measure	Neurofeedback n=24 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=10 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind Correct guesses by children	32 percentage of participants	32 percentage of participants
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind Declined to guess by children	35 percentage of participants	35 percentage of participants
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind Declined to guess by parent	29 percentage of participants	29 percentage of participants
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind Correct guesses by parents	24 percentage of participants	24 percentage of participants
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind Incorrect guesses by children	32 percentage of participants	32 percentage of participants
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind Incorrect guesses by parent	47 percentage of participants	47 percentage of participants

PRIMARY outcome

Timeframe: 24 treatments ~ 8-12 weeks

Population: Those completing 24 treatments

Parent \& child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).

Outcome measures

Outcome measures
Measure	Neurofeedback n=24 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=10 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction x2 wk Satisfaction	5.21 units on a scale Standard Deviation 1.80	5.40 units on a scale Standard Deviation 1.07
Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction x 3/wk Satisfaction	5.62 units on a scale Standard Deviation 1.27	5.08 units on a scale Standard Deviation 1.73

PRIMARY outcome

Timeframe: 24 treatments ~ 8-12 weeks

Population: participants completing treatment 24

Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.

Outcome measures

Outcome measures
Measure	Neurofeedback n=24 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=10 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice % participants changing from x2-3 treatments/week	44 percentage of participants	44 percentage of participants
Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice % participants changing from x3-2 treatments/week	22 percentage of participants	22 percentage of participants

PRIMARY outcome

Timeframe: 40 treatment sessions ~ 13-20 weeks

Population: Number of participants in active (n=24) and sham (n=10) neurofeedback completing 40 treatments.

The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.

Outcome measures

Outcome measures
Measure	Neurofeedback n=24 Participants In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.	Sham Neurofeedback n=10 Participants The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Necessary Duration of Treatment SNAP-IV Score Total at Baseline	1.91 units on a scale Standard Deviation 0.51	1.86 units on a scale Standard Deviation 0.44
Necessary Duration of Treatment SNAP-IV Score Total at Treatment 12	1.52 units on a scale Standard Deviation 0.63	1.51 units on a scale Standard Deviation 0.46
Necessary Duration of Treatment SNAP-IV Score Total at Treatment 24	1.48 units on a scale Standard Deviation 0.60	1.56 units on a scale Standard Deviation 0.52
Necessary Duration of Treatment SNAP-IV Score Total at Treatment 40	1.56 units on a scale Standard Deviation 0.70	1.42 units on a scale Standard Deviation 0.58

Adverse Events

Active Neurofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Neurofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

L. Eugene Arnold, M.D. M.Ed.

The Ohio State University

Phone: 614-685-6708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place