Neurofeedback for Youth Trauma
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Rochester
Disqualifiers: Epilepsy, High suicide risk, Psychosis
Stay on Your Current Meds
Approved in 1 Jurisdiction
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.
12345Is 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.
45678How 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.
910111213Eligibility 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.
+5 more
Exclusion Criteria
I have a documented history of epilepsy.
Child-caregiver dyads will be excluded if
I am currently experiencing psychosis.
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Rochester Medical CenterRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
References
Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports. [2022]A randomized and controlled clinical study was performed to evaluate the use of neurofeedback (NF) to treat attention-deficit/hyperactivity disorder (ADHD) in children and adolescents.
In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]To evaluate sustained improvements 6 months after a 40-session, in-school computer attention training intervention using neurofeedback or cognitive training (CT) administered to 7- to 11-year-olds with attention-deficit/hyperactivity disorder (ADHD).
Emerging brain-based interventions for children and adolescents: overview and clinical perspective. [2009]Electroencephalogram biofeedback (EBF), repetitive transcranial magnetic stimulation (rTMS), and vagal nerve stimulation (VNS) are emerging interventions that attempt to directly impact brain function through neurostimulation and neurofeedback mechanisms. This article provides a brief overview of each of these techniques, summarizes the relevant research findings, and examines the implications of this research for practice standards based on the guidelines for recommending evidence based treatments as developed by the American Academy of Child and Adolescent Psychiatry for attention deficit hyperactivity disorder (ADHD). EBF meets the "Clinical Guidelines" standard for ADHD, seizure disorders, anxiety, depression, and traumatic brain injury. VNS meets this same standard for treatment of refractory epilepsy and meets the lower "Options" standard for several other disorders. rTMS meets the standard for "Clinical Guidelines" for bipolar disorder, unipolar disorder, and schizophrenia. Several conditions are discussed regarding the use of evidence based thinking related to these emerging interventions and future directions.
Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]Neurofeedback (NF) using surface electroencephalographic signals has been used to treat various child psychiatric disorders by providing patients with video/audio information about their brain's electrical activity in real-time. Research data are reviewed and clinical recommendations are made regarding NF treatment of youth with attention deficit/hyperactivity disorder, autism, learning disorders, and epilepsy. Most NF studies are limited by methodological issues, such as failure to use or test the validity of a full-blind or sham NF. The safety of NF treatment has not been thoroughly investigated in youth or adults, although clinical experience suggests reasonable safety.
Additive effects of neurofeedback on the treatment of ADHD: A randomized controlled study. [2022]Neurofeedback (NF) has been identified as a "possibly efficacious" treatment in current evidence-based reviews; therefore, more research is needed to determine its effects. The current study examined the potential additive effect of NF for children diagnosed with ADHD beginning a medication trial first. Thirty-six children (6-12 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to an NF with medication (NF condition) or a medication only condition. Children in the NF group attended 20 twice-weekly sessions. Outcome measures included individual cognitive performance scores (ADS, K-WISC-III), ADHD rating scores completed by their parents (ARS, CRS) and brainwave indices of left and right hemispheres before and after NF treatment. Significant additive treatment effect in any of the symptom variables was found and a reduction of theta waves in both the right and left hemispheres was recorded in NF condition participants. However our randomized controlled study could not demonstrate superior effects of combined NF on intelligent functioning compared to the medication treatment only. This study suggested any possible evidence of positive and additive treatment effects of NF on brainwaves and ADHD symptomatology.
A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands.
Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). [2022]Neurofeedback has begun to attract the attention and scrutiny of the scientific and medical mainstream. Here, neurofeedback researchers present a consensus-derived checklist that aims to improve the reporting and experimental design standards in the field.
Clinical neurofeedback: case studies, proposed mechanism, and implications for pediatric neurology practice. [2011]Trends in alternative medicine use by American health care consumers are rising substantially. Extensive literature exists reporting on the effectiveness of neurofeedback in the treatment of autism, closed head injury, insomnia, migraine, depression, attention deficit hyperactivity disorder, epilepsy, and posttraumatic stress disorder. We speculated that neurofeedback might serve as a therapeutic modality for patients with medically refractory neurological disorders and have begun referring patients to train with clinical neurofeedback practitioners. The modality is not always covered by insurance. Confident their child's medical and neurological needs would continue to be met, the parents of 3 children with epilepsy spectrum disorder decided to have their child train in the modality. The children's individual progress following neurofeedback are each presented here. A proposed mechanism and practice implications are discussed.
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]Given the lack of evidence regarding effective pharmacological and non-pharmacological interventions for pediatric mild traumatic brain injury (mTBI) and the resultant lack of treatment recommendations reflected in consensus guidelines, variation in the management of pediatric mTBI is to be expected. We therefore surveyed practitioners across 15 centers in the United States and Canada who care for children with pediatric mTBI to evaluate common-practice variation in the management of pediatric mTBI. The survey, developed by a panel of pediatric mTBI experts, consisted of a 10-item survey instrument regarding providers' perception of common pediatric mTBI symptoms and mTBI interventions. Surveys were distributed electronically to a convenience sample of local experts at each center. Frequencies and percentages (with confidence intervals [CI]) were determined for survey responses. One hundred and seven respondents (71% response rate) included specialists in pediatric Emergency Medicine, Sports Medicine, Neurology, Neurosurgery, Neuropsychology, Neuropsychiatry, Physical and Occupational Therapy, Physiatry/Rehabilitation, and General Pediatrics. Respondents rated headache as the most prevalently reported symptom after pediatric mTBI, followed by cognitive problems, dizziness, and irritability. Of the 65 (61%; [95% CI: 51,70]) respondents able to prescribe medications, non-steroidal anti-inflammatory medications (55%; [95% CI: 42,68]) and acetaminophen (59%; [95% CI: 46,71]) were most commonly recommended. One in five respondents reported prescribing amitriptyline for headache management after pediatric mTBI, whereas topiramate (8%; [95% CI: 3,17]) was less commonly reported. For cognitive problems, methylphenidate (11%; [95% CI: 4,21]) was used more commonly than amantadine (2%; [95% CI: 0,8]). The most common non-pharmacological interventions were rest ("always" or "often" recommended by 83% [95% CI: 63,92] of the 107 respondents), exercise (59%; [95%CI: 49,69]), vestibular therapy (42% [95%CI: 33,53]) and cervical spine exercises (29% [95%CI: 21,39]). Self-reported utilization for common pediatric mTBI interventions varied widely across our Canadian and United States consortium. Future effectiveness studies for pediatric mTBI are urgently needed to advance the evidence-based care.
Neuropharmacology in pediatric brain injury: a review. [2013]In this review, the current evidence is examined regarding neuropharmacologic treatment for children and adolescents (under the age of 18 years) who sustained a traumatic brain injury (TBI). Although the focus is on the pediatric TBI population, there is a paucity of empirical data related to the role of medication with children and adolescents after brain injury. Therefore, findings from the adult TBI literature are incorporated where appropriate so as to identify potential agents that warrant further examination in pediatric populations. This review addresses specific sequelae of TBI from the earliest stages of neurologic recovery to long-term comorbidities, including disorders of impaired consciousness, post-TBI agitation, cognitive decline, and post-TBI depression. The evidence regarding the role of medication in neuroprotection and neurorecovery in this population is also explored. Medication classes reviewed include excitatory amino acids, antagonists to the N-methyl-D-aspartate receptor, dopamine agonists, benzodiazepines, β-blockers, anticonvulsants, and antidepressants. It is hoped that this review will guide future research, and ideas as to how this may be accomplished within a pediatric population are suggested.
[Pediatric craniocerebral trauma. Special characteristics, therapy and prognosis]. [2006]The mortality rate after traumatic brain injury in children ranges between 2.5% and 21%. Standardized diagnostic procedures and therapeutic strategies for the management of traumatic brain damage are presented in this article. Children with traumatic cerebral lesions have a better clinical outcome than head-injured adults. Optimized medical management and intensive rehabilitation may help to reduce the frequency of mental retardation and physical disability following such injuries in children.
Management of paediatric traumatic brain injury in Sweden: a national cross-sectional survey. [2022]Previous studies have shown variations in management routines for children with traumatic brain injury (TBI) in Sweden. It is unknown if this management has changed after the publication of the Scandinavian Neurotrauma Committee guidelines in 2016 (SNC16). Also, knowledge of current practice routines may guide development of an efficient implementation strategy for the guidelines. The aim of this study is therefore to describe current management routines in paediatric TBI on a hospital/organizational level in Sweden. Secondary aims are to analyse differences in management over time, to assess the current dissemination status of the SNC16 guideline and to analyse possible variations between hospitals.
Management of pediatric traumatic brain injury. [2020]Pediatric severe traumatic brain injury continues to be a major cause of disability and death. Rapid initial airway and hemodynamic stabilization is critical, followed by the need for immediate recognition of intracranial pathology that requires neurosurgical intervention. Intracranial hypertension and cerebral hypoperfusion have been recognized as major insults after trauma and management should be directed at preventing both. Sedation with opioids, moderate hyperventilation to arterial carbon dioxide level of 35-40 mmHg, hyperosmolar therapy with 3 % saline or mannitol, normothermia, and cerebrospinal fluid drainage continue to be the cornerstones of initial management of intracranial hypertension (intracranial pressure >20 mmHg). Refractory intracranial hypertension is treated with high-dose barbiturate therapy to achieve medical burst suppression on electroencephalography and decompressive craniectomy. In addition, those children require antiepileptic medications for seizure prophylaxis, adequate nutritional management, and early physical therapy and rehabilitation referrals. Most of the evidence for care of children with brain injury comes from center-specific practice and experience rather than objective data. This lack of evidence provides the ground for ongoing research; nevertheless, outcomes after traumatic brain injury continue to show improvement.