Neurofeedback Training for Healthy Adults

No longer recruiting at 1 trial location

Overseen By Aaron Kucyi, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Psychiatric, Neurological, MRI contraindication

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how neurofeedback, a technique that allows participants to see and control their brain activity, affects attention. Initially, participants will have their brain activity measured while performing tasks that test focus. In the second session, they will receive live visual feedback on their brain signals and attempt to influence these signals. The trial seeks healthy adults who have never had psychiatric or neurological disorders and are not restricted from undergoing an MRI scan. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on brain activity and attention.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this neurofeedback technique is safe for healthy adults?

Research has shown that neurofeedback is generally safe. In one study, 651 healthy individuals and 15 stroke patients underwent neurofeedback training without reporting any serious issues. Another study on EEG-based neurofeedback found it safe and easy to use. Some participants might feel tired or irritable after a session, but these feelings are temporary. Overall, participants tolerate neurofeedback well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurofeedback training because it offers a unique way to engage the brain's self-regulation capabilities. Unlike traditional treatments that might involve medications or cognitive therapies, neurofeedback provides real-time visual feedback of brain activity, empowering individuals to learn how to modulate their own brainwaves. This approach is non-invasive and drug-free, which is appealing for those seeking alternatives to pharmacological options. The potential to enhance mental performance and well-being without side effects makes it a promising area of study.

What evidence suggests that neurofeedback is effective for improving attention?

Research has shown that neurofeedback can help people control their brain activity by providing visual feedback about their brain's activity. A review of several studies found that neurofeedback training improved movement skills in healthy adults. This trial will explore neurofeedback's potential to aid learning and boost certain brain functions. Another study found that neurofeedback improved quality of life for people in addiction treatment by helping them manage cravings. Although these studies focus on different issues, they highlight neurofeedback's potential to enhance brain control and performance. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-35 who have no history of psychiatric or neurological disorders and can safely undergo MRI scans. It's designed to understand how the brain works during different tasks by recording its activity.

Exclusion Criteria

History of psychiatric or neurological disorder

Contraindication for MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Session 1: EEG and fMRI Measurement

Participants undergo simultaneous EEG and fMRI recordings while performing cognitive tasks assessing attention

1 session

1 visit (in-person)

Session 2: Neurofeedback

Participants receive real-time visual feedback of brain signals during simultaneous EEG-fMRI recording

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after neurofeedback sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback

Trial Overview The study tests if giving people real-time feedback on their brain activity helps them control it better. Participants will first have their brain activity measured while doing attention tasks, then try to modify that activity in a second session using neurofeedback.

How Is the Trial Designed?

Group I: Neurofeedback Experimental Treatment 1 Intervention

Subjects will undergo one session where they will visualize real-time feedback of signals recorded from their brains.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Neurofeedback (NFB) enables individuals to consciously control their brain activity by using real-time feedback from their neural activity, which has been traditionally done with EEG and is now enhanced by fMRI for better spatial resolution.

fMRI-NFB is feasible and can serve as a supplementary therapy tool, potentially improving treatment outcomes by allowing for more precise targeting of brain regions involved in various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. Dewiputri, WI., Auer, T.[2022]

A study involving 608 participants across 28 experiments found that including a pre-training no-feedback run significantly improves neurofeedback performance, likely by helping participants become familiar with the setup and tasks.

Patients showed better neurofeedback performance than healthy participants, possibly due to higher motivation and the need to regulate dysfunctional brain signals, suggesting that tailoring neurofeedback interventions for clinical populations could enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. Haugg, A., Renz, FM., Nicholson, AA., et al.[2021]

In a randomized controlled trial involving 54 adults with ADHD/ADD, neurofeedback therapy showed improvements in self-reported ADHD symptoms compared to a waiting-list control group, indicating its potential efficacy as a treatment.

Despite the positive self-reported outcomes, the neurofeedback intervention did not translate to improved performance on the computerized attention test (T.O.V.A.), suggesting that while participants felt better, the objective measures of attention did not reflect this improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Enabled Neuroplasticity Treatment: A Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD. Cowley, B., Holmström, É., Juurmaa, K., et al.[2022]

In a study with 25 participants, neurofeedback training targeting the sensorimotor rhythm (SMR) frequency band (12-15 Hz) improved attention by increasing perceptual sensitivity and reducing errors, indicating its effectiveness for enhancing attention.

Training on the beta1 frequency band (15-18 Hz) resulted in faster reaction times and greater brain response (P300 amplitudes) during attention tasks, suggesting it enhances arousal and alertness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG biofeedback of low beta band components: frequency-specific effects on variables of attention and event-related brain potentials. Egner, T., Gruzelier, JH.[2022]

Neurofeedback, including techniques like surface neurofeedback and advanced methods such as real-time z-score neurofeedback, shows promise in treating conditions like anxiety, mood disorders, and traumatic brain injury, particularly in children and adolescents.

The article emphasizes the need for more randomized controlled studies to establish effective clinical guidelines and to identify which patients may benefit most from neurofeedback interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG and neurofeedback in children and adolescents: anxiety disorders, depressive disorders, comorbid addiction and attention-deficit/hyperactivity disorder, and brain injury. Simkin, DR., Thatcher, RW., Lubar, J.[2015]

A review of 14 studies indicates that EEG-based neurofeedback training significantly improves upper limb rehabilitation in stroke patients compared to traditional treatments, suggesting its effectiveness in occupational therapy.

Combining EEG neurofeedback with occupational therapy may enhance rehabilitation outcomes, particularly for outpatients, highlighting the need for customized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalogram-based neurofeedback training in persons with stroke: A scoping review in occupational therapy. Yoo, IG.[2021]

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

Neurofeedback has shown positive effects in improving symptoms related to traumatic brain injury across 22 studies, indicating its potential as a treatment option.

Despite the promising results, the lack of placebo-controlled studies and standardized methodologies means that further rigorous research is needed to confirm its efficacy and establish clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and traumatic brain injury: a literature review. May, G., Benson, R., Balon, R., et al.[2022]

A structured neurofeedback training program using electroencephalography showed some positive effects on attentional performance in 24 children and adolescents with ADHD, particularly in reducing reaction times in attention tasks after 20 sessions.

While the results indicated improvements in attention, the effects were generally small and preliminary, highlighting the need for larger studies with control groups to better assess the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up. Albrecht, JS., Bubenzer-Busch, S., Gallien, A., et al.[2020]

Neurofeedback is perceived by therapists as an effective treatment for ADHD, helping to reduce symptoms and improve quality of life, especially when combined with other treatment methods.

Therapists noted challenges such as comorbid conditions and patient compliance that can affect treatment outcomes, highlighting the need for further education and awareness about neurofeedback's role in ADHD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of neurofeedback therapists in treating attention-deficit hyperactivity disorder. Oliveira, J., Pellow, J., Tsele-Tebakang, T., et al.[2022]

The study developed a new EEG-based neurofeedback method targeting the right inferior frontal gyrus (rIFG), which showed successful engagement of the intended brain region during training, as confirmed by fMRI results from a small group of 14 participants.

After two sessions of this EEG neurofeedback training with 41 participants, individuals demonstrated improved cognitive control by reducing their risk-taking behavior, indicating the method's potential efficacy for enhancing cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. Or-Borichev, A., Gurevitch, G., Klovatch, I., et al.[2023]

Neurofeedback training using real-time fMRI (rtfMRI-NF) shows promise as a non-invasive treatment for neuropsychiatric disorders, but its efficacy and clinical significance are still under investigation, as highlighted by a review of 128 studies.

The review revealed that less than one-third of studies implemented standard denoising methods, indicating a need for improved reporting and quality control practices to enhance the reliability of neurofeedback signals in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and denoising in real-time functional magnetic resonance imaging neurofeedback: A methods review. Heunis, S., Lamerichs, R., Zinger, S., et al.[2021]

Neurofeedback has shown clinical efficacy in treating children with ADHD, outperforming computerized attention training in a randomized controlled trial with a medium effect size.

The benefits of neurofeedback training appear to be stable for at least six months, with different training protocols (theta/beta and slow cortical potentials) demonstrating distinct neurophysiological mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The usage of neurofeedback in children with ADHD: the method and its evaluation]. Gevensleben, H., Moll, GH., Rothenberger, A., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790100/

Comparing LORETA Z Score Neurofeedback and Cognitive ... According to study results, LZNFB training is more effective than cognitive rehabilitation in decreasing cravings and improving the quality of life in addiction ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4892319/

Neurofeedback: A Comprehensive Review on System Design ... Neurofeedback is a kind of biofeedback, which teaches self-control of brain functions to subjects by measuring brain waves and providing a feedback signal.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022395624002413

The potential of infra-low frequency neurofeedback training ... This study tested ILF-NFT's effects in a double-blinded, placebo-controlled longitudinal context in healthy psychology students.

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.920659/full

Infra-Low Frequency Neurofeedback: A Systematic Mixed ... In this study we intend to examine the effects of Neurofeedback based on slow brain activity, the so-called Infra-Low Frequency (ILF) training.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1053811923001465

An investigation of the effectiveness of neurofeedback ... A meta-analysis of neurofeedback training (NFT) in healthy adults showed an overall positive effect on motor performance.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9670077/

Infraslow closed-loop brain training for anxiety and depression ... We intend to conduct a randomized, double-blind (participant and assessor), sham-controlled, parallel-group (3-arm) trial of sLORETA infraslow (<0.1 Hz) ...

7. nature.com nature.com/articles/s41598-024-83776-8

A safety and feasibility randomized placebo controlled trial ... This study evaluates the safety, feasibility, and acceptability of a novel electroencephalography-based neurofeedback training, targeting effective alpha-band ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352154615000625

Cognitive enhancement through real-time fMRI ... Based on predefined search criteria, we selected and examined 33 rt-fMRI neurofeedback studies, including 651 healthy individuals and 15 stroke patients in ...

9. isnr.org isnr.org/what-is-neurofeedback

What is neurofeedback? Neurofeedback training is considered safe, however, like any health-related procedure, temporary discomforts may occur, such as slight fatigue, irritability ...