NCT02205268

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

July 29, 2014

Last Update Submit

October 13, 2015

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit Disorder with HyperactivityAttention Deficit Hyperactivity DisorderBiofeedbackNeurofeedback TrainingPrefrontal CortexNear infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Recruitment and retention rates

    The primary outcome measure is the percentage of participants who complete 75% of the 20 training sessions offered.

    10 weeks

Secondary Outcomes (7)

  • Adverse effects

    10 weeks

  • Attentional and impulsivity measures

    10 weeks

  • Problem behaviour measure

    10 weeks

  • Diagnostic and severity measure

    10 weeks

  • Psychiatric and social function measure

    10 weeks

  • +2 more secondary outcomes

Study Arms (1)

Neurofeedback training

EXPERIMENTAL

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

Interventions

Near infrared spectroscopy neurofeedback trainingPROCEDURE
Neurofeedback training

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aylmer House

Harlow, Essex, CM20 1DL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Thomas M Dannhauser, PhD

    North Essex Partnerships University NHS Foundation Trust

    STUDY DIRECTOR

Central Study Contacts

Thomas M Dannhauser, PhD

CONTACT

tom.dannhauser@nepft.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2016

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

GB(1)