Real-Time Neurofeedback for Alcoholism
(RP2B Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Virginia Polytechnic Institute and State University
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
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.
12345What 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.
12345Is 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.
12346Eligibility 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.
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Real Time NeurofeedbackExperimental Treatment1 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 NeurofeedbackPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fralin Biomedical Research Institute at VTCRoanoke, VA
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Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
Fralin Biomedical Research InstituteCollaborator
References
Real-time functional magnetic resonance imaging neurofeedback can reduce striatal cue-reactivity to alcohol stimuli. [2022]It has been shown that in alcoholic patients, alcohol-related cues produce increased activation of reward-related brain regions like the ventral striatum (VS), which has been proposed as neurobiological basis of craving. Modulating this activation might be a promising option in the treatment of alcohol addiction. One approach might be real-time functional magnetic resonance imaging neurofeedback (rtfMRI NF). This study was set up to implement and evaluate a rtfMRI approach in a group of non-addicted heavy social drinkers. Thirty-eight heavy drinking students were assigned to a real feedback group (rFB, n = 13), a yoke feedback group (yFB, n = 13) and a passive control group (noFB, n = 12). After conducting a reward task as functional localizer to identify ventral striatal regions, the participants viewed alcohol cues during three NF training blocks in a 3 T MRI scanner. The rFB group received feedback from their own and the yFB from another participants' VS. The noFB group received no feedback. The rFB and the yFB groups were instructed to downregulate the displayed activation. Activation of the VS and prefrontal control regions was compared between the groups. We found significant downregulation of striatal regions specifically in the rFB group. While the rFB and the yFB groups showed significant activation of prefrontal regions during feedback, this activation was only correlated to the reduction of striatal activation in the rFB group. We conclude that rtfMRI NF is a suitable method to reduce striatal activation to alcohol cues. It might be a promising supplement to the treatment of alcoholic patients.
Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. [2022]Real-time functional magnetic resonance imaging (rtfMRI) is used for neurofeedback training (NFT). Preliminary results suggest that it can help patients to control their symptoms. This study uses rtfMRI NFT for relapse prevention in alcohol dependence.
Neuromodulation of brain activation associated with addiction: A review of real-time fMRI neurofeedback studies. [2023]Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) has emerged in recent years as an imaging modality used to examine volitional control over targeted brain activity. rtfMRI-nf has also been applied clinically as a way to train individuals to self-regulate areas of the brain, or circuitry, involved in various disorders. One such application of rtfMRI-nf has been in the domain of addictive behaviors, including substance use. Given the pervasiveness of substance use and the challenges of existing treatments to sustain abstinence, rtfMRI-nf has been identified as a promising treatment tool. rtfMRI-nf has also been used in basic science research in order to test the ability to modulate brain function involved in addiction. This review focuses first on providing an overview of recent rtfMRI-nf studies in substance-using populations, specifically nicotine, alcohol, and cocaine users, aimed at reducing craving-related brain activation. Next, rtfMRI-nf studies targeting reward responsivity and emotion regulation in healthy samples are reviewed in order to examine the extent to which areas of the brain involved in addiction can be self-regulated using neurofeedback. We propose that future rtfMRI-nf studies could be strengthened by improvements to study design, sample selection, and more robust strategies in the development and assessment of rtfMRI-nf as a clinical treatment. Recommendations for ways to accomplish these improvements are provided. rtfMRI-nf holds much promise as an imaging modality that can directly target key brain regions involved in addiction, however additional studies are needed in order to establish rtfMRI-nf as an effective, and practical, treatment for addiction.
Functional and clinical outcomes of FMRI-based neurofeedback training in patients with alcohol dependence: a pilot study. [2023]Identifying treatment options for patients with alcohol dependence is challenging. This study investigates the application of real-time functional MRI (rtfMRI) neurofeedback (NF) to foster resistance towards craving-related neural activation in alcohol dependence. We report a double-blind, placebo-controlled rtfMRI study with three NF sessions using alcohol-associated cues as an add-on therapy to the standard treatment. Fifty-two patients (45 male; 7 female) diagnosed with alcohol dependence were recruited in Munich, Germany. RtfMRI data were acquired in three sessions and clinical abstinence was evaluated 3 months after the last NF session. Before the NF training, BOLD responses and clinical data did not differ between groups, apart from anger and impulsiveness. During NF training, BOLD responses of the active group were decreased in medial frontal areas/caudate nucleus, and increased, e.g. in the cuneus/precuneus and occipital cortex. Within the active group, the down-regulation of neuronal responses was more pronounced in patients who remained abstinent for at least 3 months after the intervention compared to patients with a relapse. As BOLD responses were comparable between groups before the NF training, functional variations during NF cannot be attributed to preexisting distinctions. We could not demonstrate that rtfMRI as an add-on treatment in patients with alcohol dependence leads to clinically superior abstinence for the active NF group after 3 months. However, the study provides evidence for a targeted modulation of addiction-associated brain responses in alcohol dependence using rtfMRI.
Selecting an optimal real-time fMRI neurofeedback method for alcohol craving control training. [2023]Real-time fMRI neurofeedback (rt-fMRI-NF) is a technique in which information about an individual's neural state is given back to them, typically to enable and reinforce neuromodulation. Its clinical potential has been demonstrated in several applications, but lack of evidence on optimal parameters limits clinical utility of the technique. This study aimed to identify optimal parameters for rt-fMRI-NF-aided craving regulation training in alcohol use disorder (AUD). Adults with AUD (n = 30) participated in a single-session study of four runs of rt-fMRI-NF where they downregulated "craving-related" brain activity. They received one of three types of neurofeedback: multi-region of interest (ROI), support vector machine with continuous feedback (cSVM), and support vector machine with intermittent feedback (iSVM). Performance was assessed on the success rate, change in neural downregulation, and change in self-reported craving for alcohol. Participants had more successful trials in run 4 versus 1, as well as improved downregulation of the insula, anterior cingulate, and dorsolateral prefrontal cortex (dlPFC). Greater downregulation of the latter two regions predicted greater reduction in craving. iSVM performed significantly worse than the other two methods. Downregulation of the striatum and dlPFC, enabled by ROI but not cSVM neurofeedback, was correlated with a greater reduction in craving. rt-fMRI-NF training for downregulation of alcohol craving in individuals with AUD shows potential for clinical use, though this pilot study should be followed with a larger randomized-control trial before clinical meaningfulness can be established. Preliminary results suggest an advantage of multi-ROI over SVM and intermittent feedback approaches.
Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates. [2022]Alcohol dependence is one of the most common substance use disorders, and novel treatment options are urgently needed. Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf-MRI) has emerged as an attractive candidate for add-on treatments in psychiatry, but its use in alcohol dependence has not been formally investigated in a clinical trial. We investigated the use of rtfMRI-based NFT to prevent relapse in alcohol dependence.