Neurofeedback Training for Healthy Adults

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

24 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Neurofeedback Training for Healthy Adults?

Research shows that neurofeedback, a type of brain training, has been effective in treating conditions like ADHD by helping people control their brain activity. Studies have found that it can improve attention and brain function, and these effects can last for months. ^{1 2 3 4 5}

Is neurofeedback training safe for healthy adults?

Neurofeedback training, including methods like EEG and fMRI, is generally considered safe for healthy adults, as it is a non-invasive technique that has been used in various studies without significant safety concerns. ^{1 6 7 8 9}

How is neurofeedback training different from other treatments for brain function improvement?

Neurofeedback training is unique because it allows individuals to learn how to control their brain activity by providing real-time feedback on their neural activity, which is different from traditional treatments that do not involve this interactive, self-regulatory approach. Unlike medications or other therapies, neurofeedback uses brain wave measurements to help individuals improve cognitive functions without the use of drugs. ^{1 10 11 12 13}

What is the purpose of this trial?

Healthy adult subjects will participate in two sessions. The first session will involve measurements of brain activity using simultaneous recordings with electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI). During brain activity measurement, participants will perform cognitive tasks assessing attention. The second will involve fMRI-based neurofeedback during simultaneous EEG-fMRI recording. Participants will receive real-time visual feedback of signals measured from specific parts of their brain and will try to control that activity.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Malaysia pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Computer Enabled Neuroplasticity Treatment: A Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[The usage of neurofeedback in children with ADHD: the method and its evaluation]. [2019]

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

Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]

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

Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. [2021]

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

Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. [2023]

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

Quality and denoising in real-time functional magnetic resonance imaging neurofeedback: A methods review. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Neurofeedback and traumatic brain injury: a literature review. [2022]

12. New Zealand 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. [2020]

13. South Africa pubmed.ncbi.nlm.nih.gov

Experiences of neurofeedback therapists in treating attention-deficit hyperactivity disorder. [2022]