Neurofeedback for Youth Trauma

Overseen By Tom O'Connor, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Epilepsy, High suicide risk, Psychosis

Stay on Your Current Meds You can continue your current medications while participating

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 5 11 12 13}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have a documented history of epilepsy.

Child-caregiver dyads will be excluded if

I am currently experiencing psychosis.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback Intervention
• Standard of Care

Trial Overview The 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.

How Is the Trial Designed?

Group I: Neurofeedback Intervention plus standard of care Experimental Treatment 2 Interventions

routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week.

Group II: Standard of Care Placebo Group 1 Intervention

routine clinical psychotherapy

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging brain-based interventions for children and adolescents: overview and clinical perspective. Hirshberg, LM., Chiu, S., Frazier, JA.[2009]

Neurofeedback (NF) has been explored as a treatment for various child psychiatric disorders, including ADHD, autism, learning disorders, and epilepsy, by providing real-time feedback on brain activity.

However, many studies on NF have methodological limitations, such as not using proper blinding or sham controls, and while clinical experience suggests NF is reasonably safe, its safety has not been rigorously studied in youth or adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. Hurt, E., Arnold, LE., Lofthouse, N.[2019]

In a study involving 36 children with ADHD, neurofeedback (NF) combined with medication showed a reduction in theta brainwaves, indicating potential changes in brain activity associated with ADHD symptoms.

However, the study did not find that NF provided superior cognitive benefits compared to medication alone, suggesting that while NF may have some positive effects, it does not enhance intelligence functioning beyond medication treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additive effects of neurofeedback on the treatment of ADHD: A randomized controlled study. Lee, EJ., Jung, CH.[2022]

In a study involving 41 children with ADHD, EEG neurofeedback did not show a significant improvement in ADHD symptoms compared to placebo neurofeedback, indicating it may not be an effective treatment option.

Both treatment groups experienced a general improvement in ADHD symptoms over time, but there were no significant differences between the groups, and no clinically relevant side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. van Dongen-Boomsma, M., Vollebregt, MA., Slaats-Willemse, D., et al.[2015]

Neurofeedback is gaining recognition in scientific and medical communities, indicating its potential relevance in treatment and research.

Researchers have developed a consensus checklist to enhance the quality of reporting and experimental design in neurofeedback studies, which could lead to more reliable and effective applications of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). Ros, T., Enriquez-Geppert, S., Zotev, V., et al.[2022]

Neurofeedback is gaining popularity as an alternative treatment for various neurological disorders, including epilepsy, despite limited insurance coverage.

The individual progress of three children with epilepsy spectrum disorder who underwent neurofeedback training suggests potential therapeutic benefits, highlighting the need for further exploration of this modality in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical neurofeedback: case studies, proposed mechanism, and implications for pediatric neurology practice. Legarda, SB., McMahon, D., Othmer, S., et al.[2011]

A survey of 107 healthcare providers across 15 centers in the U.S. and Canada revealed that headache is the most common symptom reported after pediatric mild traumatic brain injury (mTBI), with non-steroidal anti-inflammatory medications and acetaminophen being the most frequently recommended treatments.

There is significant variation in the management of pediatric mTBI, with 83% of respondents recommending rest as a common non-pharmacological intervention, highlighting the need for more evidence-based guidelines in treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Patterns in Pharmacological and Non-Pharmacological Therapies for Children with Mild Traumatic Brain Injury: A Survey of 15 Canadian and United States Centers. Mannix, R., Zemek, R., Yeates, KO., et al.[2020]

There is limited empirical data on the use of neuropharmacologic treatments for children and adolescents with traumatic brain injury (TBI), highlighting a need for more research in this area.

The review discusses various medication classes, such as dopamine agonists and antidepressants, that may aid in neuroprotection and recovery after TBI, suggesting potential avenues for future studies in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropharmacology in pediatric brain injury: a review. Pangilinan, PH., Giacoletti-Argento, A., Shellhaas, R., et al.[2013]

The mortality rate for children after traumatic brain injury varies from 2.5% to 21%, indicating a significant risk associated with these injuries.

Children tend to have better clinical outcomes than adults with similar head injuries, and improved medical management and rehabilitation can help decrease the chances of long-term disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pediatric craniocerebral trauma. Special characteristics, therapy and prognosis]. Maier-Hauff, K., Gatzounis, G., Börschel, M.[2006]

A survey of 66 hospitals in Sweden revealed that 76% have established guidelines for managing pediatric traumatic brain injury (TBI), indicating an improvement in clinical decision-making since the 2006 baseline.

Despite improvements, management still varies significantly across hospitals, with 84% of TBI cases being handled by inexperienced doctors from non-pediatric specialties, highlighting a need for further training and standardization in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of paediatric traumatic brain injury in Sweden: a national cross-sectional survey. Wickbom, F., Persson, L., Olivecrona, Z., et al.[2022]

Rapid stabilization of airway and blood flow is crucial in managing pediatric severe traumatic brain injury, with key treatments including sedation, hyperventilation, and hyperosmolar therapy to prevent intracranial hypertension and cerebral hypoperfusion.

Current management strategies for refractory intracranial hypertension involve high-dose barbiturate therapy and decompressive craniectomy, but much of the evidence is based on specific center practices rather than large-scale studies, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pediatric traumatic brain injury. Mtaweh, H., Bell, MJ.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Emerging brain-based interventions for children and adolescents: overview and clinical perspective. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Additive effects of neurofeedback on the treatment of ADHD: A randomized controlled study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical neurofeedback: case studies, proposed mechanism, and implications for pediatric neurology practice. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Neuropharmacology in pediatric brain injury: a review. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

[Pediatric craniocerebral trauma. Special characteristics, therapy and prognosis]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Management of paediatric traumatic brain injury in Sweden: a national cross-sectional survey. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Management of pediatric traumatic brain injury. [2020]