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Trial record 19 of 156 for:    neurofeedback

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

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ClinicalTrials.gov Identifier: NCT00886483
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : November 28, 2013
Last Update Posted : November 11, 2016
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Brain Resource Center
Information provided by (Responsible Party):
L. Eugene Arnold, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Device: Active Neurofeedback
Device: Sham neurofeedback
Enrollment 39
Recruitment Details Dates of recruitment: August 2008 to December 2009. Location: Nisonger Center, OSU Medical Center
Pre-assignment Details 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.
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 26 13
Completed 20 Treatments 25 11
Completed 24 10
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             0             1
Pursue medications             1             2
Distance to center, poor grades             1             0
Arm/Group Title Active Neurofeedback Sham Neurofeedback Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 26 13 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 13 participants 39 participants
<=18 years
26
 100.0%
13
 100.0%
39
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 13 participants 39 participants
9.0  (1.5) 8.7  (2.1) 8.9  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 13 participants 39 participants
Female
4
  15.4%
9
  69.2%
13
  33.3%
Male
22
  84.6%
4
  30.8%
26
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 13 participants 39 participants
26 13 39
1.Primary Outcome
Title Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number
Hide Description The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on inclusion & exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.
Arm/Group Title Neurofeedback Sham Neurofeedback
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 26 13
Measure Type: Number
Unit of Measure: participants
26 13
2.Primary Outcome
Title Feasibility of Double-blind, Sham-controlled Design #2. Retention
Hide Description 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).
Time Frame 40th treatment sessions ~ 13-20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number randomized was denominator for percentage of participants completing 40 treatment sessions.
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description:
Number of participants in the Neurofeedback group (n=26) that completed treatment through the 40th treatment (n=24).
Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 40th treatment (n=10).
Overall Number of Participants Analyzed 26 13
Measure Type: Number
Unit of Measure: percentage of participants
92.3 76.9
3.Primary Outcome
Title Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind
Hide Description 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.
Time Frame Post-treatment at session 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description:
Correct guess vs. incorrect guess/don't know/decline to guess for Neurofeedback group.
Correct guess vs. incorrect guess/don't know/decline to guess for Sham Neurofeedback group.
Overall Number of Participants Analyzed 24 10
Measure Type: Number
Unit of Measure: percentage of participants
Declined to guess by children 35 35
Declined to guess by parent 29 29
Correct guesses by children 32 32
Correct guesses by parents 24 24
Incorrect guesses by children 32 32
Incorrect guesses by parent 47 47
4.Primary Outcome
Title Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction
Hide Description 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).
Time Frame 24 treatments ~ 8-12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Those completing 24 treatments
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description:
Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
Overall Number of Participants Analyzed 24 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
x2 wk Satisfaction 5.21  (1.80) 5.40  (1.07)
x 3/wk Satisfaction 5.62  (1.27) 5.08  (1.73)
5.Primary Outcome
Title Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice
Hide Description 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.
Time Frame 24 treatments ~ 8-12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing treatment 24
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description:
Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
Overall Number of Participants Analyzed 24 10
Measure Type: Number
Unit of Measure: percentage of participants
% participants changing from x2-3 treatments/week 44 44
% participants changing from x3-2 treatments/week 22 22
6.Primary Outcome
Title Necessary Duration of Treatment
Hide Description 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.
Time Frame 40 treatment sessions ~ 13-20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants in active (n=24) and sham (n=10) neurofeedback completing 40 treatments.
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description:
All participants in the Active group completing 40 treatments
Participants in the Sham group completing 40 treatments
Overall Number of Participants Analyzed 24 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
SNAP-IV Score Total at Baseline 1.91  (0.51) 1.86  (0.44)
SNAP-IV Score Total at Treatment 12 1.52  (0.63) 1.51  (0.46)
SNAP-IV Score Total at Treatment 24 1.48  (0.60) 1.56  (0.52)
SNAP-IV Score Total at Treatment 40 1.56  (0.70) 1.42  (0.58)
Time Frame 40 treatment sessions
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Neurofeedback Sham Neurofeedback
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Active Neurofeedback Sham Neurofeedback
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Neurofeedback Sham Neurofeedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Neurofeedback Sham Neurofeedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/13 (0.00%) 
  1. Small sample.
  2. Self-selection families willing to stop/delay meds.
  3. Failure to select for high TBR.
  4. Small/medium pre-post ES suggests particular Tx technology may not have been the most effective.
  5. Sham NF may not have been inert.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: L. Eugene Arnold, M.D. M.Ed.
Organization: The Ohio State University
Phone: 614-685-6708
Responsible Party: L. Eugene Arnold, Ohio State University
ClinicalTrials.gov Identifier: NCT00886483     History of Changes
Other Study ID Numbers: 2008H0019-A
1R34MH080775-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: July 2, 2012
Results First Posted: November 28, 2013
Last Update Posted: November 11, 2016