Near Infrared Spectroscopy Neurofeedback Training for ADHD (ADHDNTx)
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|ClinicalTrials.gov Identifier: NCT02205268|
Recruitment Status : Unknown
Verified October 2015 by Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : July 31, 2014
Last Update Posted : October 14, 2015
Background Attention Deficit Hyperactivity Disorder (ADHD) is one of the most frequently diagnosed behavioural disorders in childhood that requires treatment(3-5% of children). It is an important health problem because it impairs social, educational and occupational performance, and increases the risk of other psychiatric disorders including anxiety, depression and substance misuse. There is no cure for ADHD and standard stimulant medication treatment is at best symptomatic. Moreover, stimulants have side effects and parents are often concerned over the long-term effects. A number of non-drug treatments have been developed but these do not target the brain directly. Neurofeedback Training (NTx) is a new, non-drug treatment that targets the brain directly and that can potentially enhance the control of attention in ADHD. NTx could be a valuable alternative and/or adjunct to standard care.
Aims Although NTx has gained popularity in Europe and the US, more rigorous studies are required to support its implementation in the NHS. We therefore propose a pilot study to establish tolerabilty and safety, and to develop treatment protocols and collect data to design a follow-on controlled NTx trial in ADHD.
Methods We plan an open label, single arm, treatment trial of near infrared spectroscopy neurofeedback training of frontal lobe activation in school-aged children with ADHD. 48 participants will be recruited over 1 year and will be offered 20 NTx sessions over 10 weeks. Participants will be recruited from Mental Health Services. Primary outcomes will be safety and tolerability and secondary outcomes will include standard clinical behavioural rating scales and the Test Of the Variables of Attention.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder||Procedure: Near infrared spectroscopy neurofeedback training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Near Infrared Spectroscopy Neurofeedback Training of Prefrontal Cortex in Attention Deficit Hyperactivity Disorder|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2016|
Experimental: Neurofeedback training
20 sessions of near infrared spectroscopy neurofeedback training to increase activation to bilateral prefrontal cortex. Two sessions per week.
Procedure: Near infrared spectroscopy neurofeedback training
- Recruitment and retention rates [ Time Frame: 10 weeks ]The primary outcome measure is the percentage of participants who complete 75% of the 20 training sessions offered.
- Adverse effects [ Time Frame: 10 weeks ]Occurrence and frequency of training related adverse effects.
- Attentional and impulsivity measures [ Time Frame: 10 weeks ]Test of Variables of attention (TOVA)
- Problem behaviour measure [ Time Frame: 10 weeks ]Childhood behavioural checklist (CBCL)
- Diagnostic and severity measure [ Time Frame: 10 weeks ]Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)
- Psychiatric and social function measure [ Time Frame: 10 weeks ]Children's Global Assessment Scale. The CGAS is an adaptation of the Global Assessment Scale (GAS) for young people aged 4-16 years
- Treatment response assessment [ Time Frame: 10 weeks ]CGI (Clinical Global Impression) is a three-item scale used to assess treatment response in psychiatric patients
- Study satisfaction questionnaire [ Time Frame: 10 weeks ]Measure of satisfaction of participating.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205268
|Contact: Thomas M Dannhauser, PhDemail@example.com|
|Harlow, Essex, United Kingdom, CM20 1DL|
|Study Director:||Thomas M Dannhauser, PhD||North Essex Partnerships University NHS Foundation Trust|