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Near Infrared Spectroscopy Neurofeedback Training for ADHD (ADHDNTx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
University College, London
Hertfordshire Community NHS Trust
Information provided by (Responsible Party):
Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: 10 weeks ]
    Occurrence and frequency of training related adverse effects.

  2. Attentional and impulsivity measures [ Time Frame: 10 weeks ]
    Test of Variables of attention (TOVA)

  3. Problem behaviour measure [ Time Frame: 10 weeks ]
    Childhood behavioural checklist (CBCL)

  4. Diagnostic and severity measure [ Time Frame: 10 weeks ]
    Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)

  5. 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

  6. Treatment response assessment [ Time Frame: 10 weeks ]
    CGI (Clinical Global Impression) is a three-item scale used to assess treatment response in psychiatric patients

  7. Study satisfaction questionnaire [ Time Frame: 10 weeks ]
    Measure of satisfaction of participating.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with ADHD aged 7 to 17 years
  • Patient and legal guardian able to communicate in English
  • Patient has been living with parent/guardian for at least six months
  • Patient attending school for at least 2 days / week
  • ADHD as primary disorder with symptoms present for at least 9 months
  • Participants on medication treatment for ADHD must have been on a stable dose for 3 months prior to commencement of the treatment

Exclusion Criteria:

  • Significant visual or hearing impairment that would preclude use of NIRS- neurofeedback
  • Global learning disability, Autism, psychosis, bipolar disorder, depression, suicidal ideation, or another psychiatric disorder requiring treatment with additional psychotropic medication, current substance dependance or regular use, and severe sleep disorders

Information from the National Library of Medicine

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


Contacts
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Contact: Thomas M Dannhauser, PhD tom.dannhauser@nepft.nhs.uk

Locations
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United Kingdom
Aylmer House Recruiting
Harlow, Essex, United Kingdom, CM20 1DL
Sponsors and Collaborators
North Essex Partnership NHS Foundation Trust
University College, London
Hertfordshire Community NHS Trust
Investigators
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Study Director: Thomas M Dannhauser, PhD North Essex Partnerships University NHS Foundation Trust

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Responsible Party: Dr Thomas Dannhauser, Chief Investigator, North Essex Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02205268    
Other Study ID Numbers: NEPADHDNTX
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust:
Attention Deficit Disorder with Hyperactivity
Attention Deficit Hyperactivity Disorder
Biofeedback
Neurofeedback Training
Prefrontal Cortex
Near infrared spectroscopy
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms