Project Description:
This add-on follows the same overarching protocol and references as the original ICAN study. For this protocol, at each of the two sites (1 university & 1 neurofeedback clinic) 5 children from the placebo group in the ICAN study and from the general population (total N=10) ages 9 through 16 with ADHD will be given the opportunity to receive a real at home neurofeedback (NF) treatment. This group will also be those considered to be non-responders in the original ICAN study, meaning their symptoms did not show a significant benefit from the ICAN study overall (i.e., a good placebo response). Additional outside participants who have not had NF treatment and who fit the enrollment criteria may also be recruited.
One major specific aim is to provide a real neurofeedback treatment to participants in the non-responder placebo group of the previous neurofeedback study. Another specific aim is to check feasibility of a RCT of Myndlift treatment. The main hypothesis for this study is the same which is that NF will improve parent- and teacher-rated inattentive symptoms (primary outcome) and the other outcomes included in this add-on.
This is a 2-site study based on the ICAN study using the Myndlift treatment during a 10-week period, with a baseline and training visit (1), a telephone consultation, and a final end of study visit (2) in 10 children age 9-16 with rigorously diagnosed DSM-5ADHD.
All participants will be given the same Myndlift treatment.
Myndlift is a clinician-guided neurofeedback system consisting of a commercially-available headset (Muse; InteraXon, Inc., Canada)
Myndlift is designed for training in-clinic or by patients at home.
Real-time EEG data is sent to a web-based clinician dashboard while the client trains on a mobile app that delivers a task, video, or audio clip and provides positive feedback when brain activity is in line with goals specified in the personalized neurofeedback protocol set by the clinician. Myndlift is designed for training in-clinic or by patients at home relative to clinical-grade wet electrode systems, Myndlift involves much simpler and faster setup. Systems such as Myndlift have the potential to facilitate training more often and improve training adherence.
Question: Is it feasible for Myndlift treatment to be subjected to a randomized controlled trial?
Hypothesis 1A (Primary outcome 1, practicality): Families will learn in one training visit the correct application and use of the device as measured by electronic monitoring and need for additional training.
Hypothesis 1B (Primary outcome 2, Adherence): Adherence will average >90% by electronic monitoring
Hypothesis 1C: (Primary outcome 3, recruitment) Over half of those invited will participate.
Hypothesis 1C: (Primary outcome 4, palatability) Seventy percent or more will give favorable ratings on a satisfaction questionnaire at the end and would recommend it for others.
Hypothesis 2: Children given the Myndlift treatment will show reduction from baseline of inattentive ADHD symptoms rated by parents.
Unserved or Under-served Populations:
Disadvantaged Circumstances, Specific Groups
