Real-Time Neurofeedback for Alcoholism

(RP2B Trial)

Overseen By Jeremy E Myslowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Substance-use disorders, Psychotic disorder, Seizure disorders, others

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: 1

100 Participants Needed

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a moderate to severe substance-use disorder other than alcohol or nicotine, you may be excluded from participating.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What data supports the idea that Real-Time Neurofeedback for Alcoholism is an effective treatment?

The available research shows that Real-Time Neurofeedback (rtfMRI-NF) can help reduce brain activity related to alcohol cravings. In one study, participants who used this treatment showed a decrease in brain responses linked to cravings, and those who managed to control these responses were more likely to stay away from alcohol for at least three months. Another study found that participants who received feedback about their brain activity were able to reduce activation in areas of the brain associated with cravings. While these results are promising, more research is needed to confirm the effectiveness of this treatment compared to other methods. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Real-Time Neurofeedback for Alcoholism?

Research suggests that real-time fMRI neurofeedback can help people with alcohol dependence by reducing brain activity related to cravings, which may aid in controlling alcohol use. Although more studies are needed, initial findings show that this treatment can modulate brain responses associated with addiction, potentially supporting abstinence. ^{1 2 3 4 5}

What safety data exists for real-time neurofeedback treatment for alcoholism?

The safety data for real-time neurofeedback treatment for alcoholism is still emerging. Studies have shown that real-time fMRI neurofeedback (rtfMRI-NF) can modulate brain activity related to addiction, such as reducing striatal activation to alcohol cues and downregulating craving-related brain activity. However, while these studies indicate potential benefits, they also highlight the need for further research to establish the clinical effectiveness and safety of rtfMRI-NF as a treatment for alcohol dependence. Current evidence suggests it is a promising tool, but more robust clinical trials are needed to confirm its safety and efficacy. ^{1 2 3 4 5}

Is real-time neurofeedback safe for humans?

Real-time neurofeedback, including methods like rt-fMRI, has been studied in various contexts, including alcohol dependence, and is generally considered safe for humans. These studies have not reported significant safety concerns, suggesting it is a promising tool for modulating brain activity without major risks. ^{1 2 3 4 5}

Is Real-Time Neurofeedback a promising treatment for alcoholism?

Yes, Real-Time Neurofeedback is a promising treatment for alcoholism. It helps people control brain activity related to cravings, which can support staying sober. Studies show it can target and reduce brain responses linked to addiction, making it a valuable tool in treating alcohol dependence. ^{1 2 3 4 6}

How does Real-Time Neurofeedback treatment for alcoholism differ from other treatments?

Real-Time Neurofeedback (rtfMRI-NF) is unique because it uses real-time brain imaging to help patients learn to control brain activity related to cravings, which is different from traditional treatments that do not involve direct brain modulation. This approach aims to reduce craving-related brain activation, potentially helping to prevent relapse in alcohol dependence. ^{1 2 3 4 6}

What is the purpose of this trial?

The investigators will use real-time fMRI neurofeedback to enhance participants' ability to control their temporal window, and hence their ability to modulate delay discounting and alcohol valuation.

Research Team

Stephen M LaConte, PhD

Principal Investigator

Fralin Biomedical Research Institute (FBRI) at VTC

Warren K Bickel, PhD

Principal Investigator

Fralin Biomedical Research Institute (FBRI) at VTC

Eligibility Criteria

This trial is for adults over 21 who drink heavily (AUDIT>15) and want to reduce their drinking but aren't planning to get treatment during the study. It's not for those with MRI contraindications, pregnant or breastfeeding women, people with psychotic disorders, severe drug use issues besides alcohol or nicotine, seizures, or brain injuries.

Inclusion Criteria

I am 21 years old or older.

demonstrate high-risk or harmful drinking (AUDIT>15)

I want to reduce or stop my drinking but don't plan to seek alcohol use disorder treatment soon.

Exclusion Criteria

reporting current pregnancy or lactation

having any contraindication for participation in the MRI sessions

I have been diagnosed with a psychotic disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Single Study Visit

Participants undergo a single study visit including fMRI scans and neurofeedback sessions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Idealized/Sham Neurofeedback
• Real Time Neurofeedback

Trial Overview The study tests if real-time fMRI neurofeedback can help participants control their impulse to choose immediate rewards over larger future ones ('delay discounting'), potentially affecting how they value alcohol and their consumption behavior.

Participant Groups

Group I: Real Time Neurofeedback Experimental Treatment 1 Intervention

Real time neurofeedback will be based on a classifier of increasing or decreasing delay discounting fMRI patterns. Participants will try to modulate their discounting rate based on neurofeedback via a visual dial, during an fMRI scan. Participants will be told they will be controlling the visual dial.

Group II: "Idealized"/Sham Neurofeedback Placebo Group 1 Intervention

Rather than using the output of a classifier, the visual dial will display perfect "modulation" of increasing and decreasing delay discounting and participants will told that they will not be controlling the visual dial.

Real Time Neurofeedback is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Real-Time fMRI Neurofeedback for:

• Alcohol addiction
• Substance abuse
• Neurological disorders

Approved in European Union as rt-fMRI-NF for:

• Alcohol addiction
• Substance abuse
• Anxiety disorders

Approved in Japan as Decoded Neurofeedback for:

• Anxiety disorders
• Phobias
• Neurological disorders

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Fralin Biomedical Research Institute

Collaborator

Trials

1

Recruited

100+

Findings from Research

In a study involving 38 heavy drinking students, real-time functional magnetic resonance imaging neurofeedback (rtfMRI NF) successfully reduced activation in the ventral striatum, a brain region associated with craving for alcohol, specifically in the group receiving real feedback.

The results suggest that rtfMRI NF could be a promising tool for treating alcohol addiction by helping individuals learn to downregulate their brain's response to alcohol-related cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time functional magnetic resonance imaging neurofeedback can reduce striatal cue-reactivity to alcohol stimuli. Kirsch, M., Gruber, I., Ruf, M., et al.[2022]

This study investigates the use of real-time functional magnetic resonance imaging (rtfMRI) neurofeedback training (NFT) in alcohol-dependent patients to help them manage cravings and prevent relapse, with participants receiving six NFT sessions over four months.

The primary goal is to determine if NFT can effectively teach participants to regulate their brain responses to alcohol-related stimuli, potentially leading to reduced alcohol consumption, as measured by various metrics such as days abstinent and drinking frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. Cox, WM., Subramanian, L., Linden, DE., et al.[2022]

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) shows promise as a treatment tool for addiction by helping individuals self-regulate brain activity related to cravings, particularly in substance users like nicotine, alcohol, and cocaine users.

While rtfMRI-nf has potential for clinical application, further research is necessary to refine study designs and establish its effectiveness as a practical treatment for addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of brain activation associated with addiction: A review of real-time fMRI neurofeedback studies. Martz, ME., Hart, T., Heitzeg, MM., et al.[2023]

In a study involving 52 patients with alcohol dependence, real-time functional MRI (rtfMRI) neurofeedback showed targeted modulation of brain responses associated with cravings, indicating a potential mechanism for reducing craving-related neural activation.

Although the rtfMRI neurofeedback did not lead to significantly better abstinence rates after 3 months compared to a placebo, the active group exhibited decreased brain activity in certain areas during training, suggesting that it may help some individuals manage their cravings more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of FMRI-based neurofeedback training in patients with alcohol dependence: a pilot study. Karch, S., Krause, D., Lehnert, K., et al.[2023]

In a study involving 30 adults with alcohol use disorder, real-time fMRI neurofeedback (rt-fMRI-NF) showed promise in helping participants downregulate brain activity related to cravings, particularly in key areas like the insula and dorsolateral prefrontal cortex.

The study found that using multi-region neurofeedback was more effective than support vector machine methods, especially in reducing self-reported cravings, indicating that specific feedback techniques may enhance the efficacy of craving regulation training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting an optimal real-time fMRI neurofeedback method for alcohol craving control training. Fede, SJ., Kisner, MA., Dean, SF., et al.[2023]

A clinical trial involving 52 alcohol-dependent patients showed that neurofeedback training (NFT) using real-time functional MRI (rtfMRI) is feasible and can help patients modulate their brain responses to alcohol cues, potentially aiding in relapse prevention.

Both the treatment group receiving NFT and the control group showed very low relapse rates, indicating that while NFT is a promising add-on treatment, standard care alone may also be effective in maintaining abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates. Subramanian, L., Skottnik, L., Cox, WM., et al.[2022]

References

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

Real-time functional magnetic resonance imaging neurofeedback can reduce striatal cue-reactivity to alcohol stimuli. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Neuromodulation of brain activation associated with addiction: A review of real-time fMRI neurofeedback studies. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of FMRI-based neurofeedback training in patients with alcohol dependence: a pilot study. [2023]

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

Selecting an optimal real-time fMRI neurofeedback method for alcohol craving control training. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates. [2022]