40 Participants Needed

Neurofeedback for Youth Trauma

TO
Overseen ByTom O'Connor, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
Stay on Your Current MedsYou can continue your current medications while participating
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the feasibility and effectiveness of a neurofeedback intervention conducted as an adjunctive behavioral health treatment to reduce trauma and affective symptoms in trauma-exposed youth.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Neurofeedback Intervention for youth trauma?

Research shows that neurofeedback, which helps people learn to control their brain activity, has been effective in treating conditions like ADHD, anxiety, and depression. This suggests it might also help with youth trauma by improving brain function and emotional regulation.12345

Is neurofeedback generally safe for children?

The safety of neurofeedback treatment has not been thoroughly investigated in youth or adults, but clinical experience suggests it is reasonably safe.45678

How does the neurofeedback treatment for youth trauma differ from standard care?

Neurofeedback is a unique treatment that uses real-time monitoring of brain activity to help individuals learn to regulate their brain function, which is different from standard care that often involves medication or physical therapies. This approach is novel because it focuses on training the brain directly, rather than using drugs or physical interventions.910111213

Eligibility Criteria

This trial is for children aged 6-12 who have experienced trauma and are receiving or eligible for trauma-focused therapy. They must have a caregiver, speak English, and own a device compatible with the MUSE Calm app. Children at high risk of suicide, experiencing psychosis, or with epilepsy cannot participate.

Inclusion Criteria

speaks and read English
I am a child.
The caregiver has reported that the child has experienced multiple adverse childhood experiences (ACEs) on a questionnaire.
See 5 more

Exclusion Criteria

I have a documented history of epilepsy.
Child-caregiver dyads will be excluded if
I am currently experiencing psychosis.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week

12 weeks
3-4 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Neurofeedback Intervention
  • Standard of Care
Trial OverviewThe study is examining if neurofeedback can help reduce symptoms in traumatized youth when added to standard care. Participants will use the MUSE wearable device alongside their usual therapy to see if it improves outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Neurofeedback Intervention plus standard of careExperimental Treatment2 Interventions
routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week.
Group II: Standard of CarePlacebo Group1 Intervention
routine clinical psychotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Findings from Research

In a study involving 91 children and adolescents with ADHD, neurofeedback (NF) treatment was found to be as effective as the standard medication methylphenidate in reducing symptoms of inattention and hyperactivity, based on parental reports.
The study included 30 sessions of NF and compared three groups: one receiving NF, one receiving methylphenidate, and one receiving both, but no significant differences were found between the treatment groups, suggesting NF could be a viable alternative to medication.
Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports.Duric, NS., Assmus, J., Gundersen, D., et al.[2022]
In a study of 104 children aged 7 to 11 with ADHD, those who received neurofeedback showed sustained improvements in attention and executive functioning six months after a 40-session intervention, with effect sizes indicating significant benefits over cognitive training and control groups.
Neurofeedback participants maintained their stimulant medication dosage, while those in cognitive training and control groups required significant increases in medication, suggesting that neurofeedback may be a more effective treatment option for managing ADHD symptoms.
In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial.Steiner, NJ., Frenette, EC., Rene, KM., et al.[2022]
Electroencephalogram biofeedback (EBF) is recognized as a clinically effective treatment for ADHD, seizure disorders, anxiety, depression, and traumatic brain injury, meeting the 'Clinical Guidelines' standard set by the American Academy of Child and Adolescent Psychiatry.
Repetitive transcranial magnetic stimulation (rTMS) is also endorsed under 'Clinical Guidelines' for treating bipolar disorder, unipolar disorder, and schizophrenia, indicating its efficacy in managing these mental health conditions.
Emerging brain-based interventions for children and adolescents: overview and clinical perspective.Hirshberg, LM., Chiu, S., Frazier, JA.[2009]

References

Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports. [2022]
In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]
Emerging brain-based interventions for children and adolescents: overview and clinical perspective. [2009]
Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]
Additive effects of neurofeedback on the treatment of ADHD: A randomized controlled study. [2022]
A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]
Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). [2022]
Clinical neurofeedback: case studies, proposed mechanism, and implications for pediatric neurology practice. [2011]
Practice Patterns in Pharmacological and Non-Pharmacological Therapies for Children with Mild Traumatic Brain Injury: A Survey of 15 Canadian and United States Centers. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Neuropharmacology in pediatric brain injury: a review. [2013]
[Pediatric craniocerebral trauma. Special characteristics, therapy and prognosis]. [2006]
Management of paediatric traumatic brain injury in Sweden: a national cross-sectional survey. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Management of pediatric traumatic brain injury. [2020]