Neurofeedback + TMS for Alcoholism

(CNT Trial)

Overseen By SCAMPI Lab

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: MRI contraindications, TMS contraindications, schizophrenia, others

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

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to assist individuals with Alcohol Use Disorder through brain treatments called neurofeedback and TMS (transcranial magnetic stimulation). Neurofeedback allows participants to view their brain activity in real time, while TMS uses magnetic pulses to stimulate specific brain areas. The trial includes different groups: some will receive both treatments, one, or none, to determine the most effective combination. Individuals currently receiving help for Alcohol Use Disorder might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medications that lower the seizure threshold, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that real-time fMRI neurofeedback has been safely used in people, including those with Alcohol Use Disorder. These studies have found no major safety issues, suggesting that the treatment is generally well-tolerated.

For TMS (transcranial magnetic stimulation), studies indicate it can be a safe option for treating alcohol addiction. Although some research is still ongoing for its use specifically in alcohol dependence, TMS is generally considered safe and has been used for other conditions.

Overall, both treatments appear to be well-tolerated. However, like any treatment, there may be some risks, so discussing any concerns with the clinical trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining neurofeedback and TMS (transcranial magnetic stimulation) for treating alcoholism because these methods offer a fresh approach. While most existing treatments for alcoholism involve medications or behavioral therapy, this protocol uses real-time fMRI neurofeedback to help patients visualize their own brain activity, potentially enhancing self-regulation. TMS adds another layer by stimulating specific brain regions with magnetic pulses, which could help modulate brain activity related to addiction. This combination aims to directly influence the brain's function, offering a novel mechanism of action compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder?

Research has shown that real-time fMRI neurofeedback can reduce cravings in individuals with substance use problems, such as alcohol addiction. This method targets brain areas linked to cravings and alters brain function, helping individuals better control their urges to drink. In this trial, some participants will receive active neurofeedback, while others will receive a sham version.

Studies have found that Transcranial Magnetic Stimulation (TMS) can lower alcohol cravings and reduce the number of heavy drinking days. TMS uses magnetic pulses to stimulate specific brain areas, decreasing the desire to drink. Participants in this trial will receive either active TMS or a sham version. Both treatments offer promising support for those dealing with Alcohol Use Disorder. ^{3 6 7 8 9}

Who Is on the Research Team?

Samantha J Fede, PhD

Principal Investigator

Auburn University

Are You a Good Fit for This Trial?

This trial is for adults aged 19-65 who are currently receiving treatment for Alcohol Use Disorder. It's not suitable for those with significant head injuries, claustrophobia that prevents MRI scans, neurological diseases, seizure history, certain metal implants or body metal including facial tattoos, medications lowering seizure threshold, active alcohol withdrawal symptoms, hearing loss worsened by MRI/TMS or a family history of schizophrenia.

Inclusion Criteria

Receiving treatment for Alcohol Use Disorder

I am between 19 and 65 years old.

Exclusion Criteria

TMS Contraindications

I have a medical device implanted in my head or one that uses body signals.

MRI Contraindications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly intervention sessions for four weeks, which may include TMS and MRI

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored monthly for up to 12 months with remote follow-ups and in-person MRI follow-ups at 6 and 12 months

12 months

Monthly remote follow-ups, 2 in-person MRI follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Realtime fMRI Neurofeedback - Active
• Realtime fMRI Neurofeedback - Yoked Sham
• TMS - Active
• TMS - Sham

Trial Overview The study tests if additional fMRI neurofeedback and TMS (Transcranial Magnetic Stimulation) can help people being treated for Alcohol Use Disorder. Participants will undergo weekly sessions over four weeks and have follow-ups via remote contact monthly up to one year with two extra MRI sessions at six and twelve months.

How Is the Trial Designed?

Group I: Neurofeedback-active + TMS-active Experimental Treatment 2 Interventions

4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)

Group II: Neurofeedback-active + TMS-sham Active Control 2 Interventions

4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)

Group III: Check-In Only Active Control 1 Intervention

4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)

Group IV: Neurofeedback-sham + TMS-active Active Control 2 Interventions

4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)

Group V: Neurofeedback-sham + TMS-sham Placebo Group 2 Interventions

4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

High-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral pre-frontal cortex significantly reduced alcohol craving in 45 patients with alcohol dependence, demonstrating its potential as an effective treatment strategy.

The study showed a moderate effect size for the anticraving effects of rTMS, suggesting that it could be combined with other medications to further reduce cravings and prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Mishra, BR., Nizamie, SH., Das, B., et al.[2022]

In a study involving 19 alcohol-dependent patients, higher baseline activation of the dorsal anterior cingulate cortex (dACC) was associated with a lower likelihood of relapse after treatment, suggesting it may act as a protective factor against relapse.

Accelerated high-frequency rTMS treatment increased dACC activation in patients with lower baseline levels, indicating that this intervention can modify brain activity related to relapse risk, although 68% of participants relapsed within 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated HF-rTMS Protocol has a Rate-Dependent Effect on dACC Activation in Alcohol-Dependent Patients: An Open-Label Feasibility Study. Herremans, SC., De Raedt, R., Van Schuerbeek, P., et al.[2016]

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 60 male inpatients with alcohol dependence, repetitive transcranial magnetic stimulation (rTMS) was administered over ten daily sessions, targeting the left dorsolateral prefrontal cortex (DLPFC).

The results showed no significant reduction in alcohol craving scores immediately after treatment or two weeks later, indicating that rTMS may not be effective for reducing cravings in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sham-controlled trial of repetitive transcranial magnetic stimulation over left dorsolateral prefrontal cortex and its effects on craving in patients with alcohol dependence. Raikwar, S., Divinakumar, KJ., Prakash, J., et al.[2022]

High-frequency repetitive transcranial magnetic stimulation (rTMS) at 10 Hz for 14 days significantly improved attention bias towards alcohol-related cues and reduced impulsivity in male patients with alcohol use disorder (AUD) after acute withdrawal, as evidenced by shorter response times in cognitive tasks.

Patients receiving rTMS also showed significant improvements in cognitive function, with increased scores on the Montreal Cognitive Assessment (MoCA) and decreased scores on the Barratt Impulsiveness Scale (BIS-II), indicating enhanced cognitive abilities and reduced impulsiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Visual Selective Attention in Male Patients With Alcohol Use Disorder After the Acute Withdrawal. Feng, Z., Wu, Q., Wu, L., et al.[2023]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29343230/

The SyBil-AA real-time fMRI neurofeedback study Discussion: The results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S092549272400009X

Neurofeedback for alcohol addiction: Changes in resting ... The aim of this study was to investigate whether neurofeedback training can alter resting state fMRI activity in brain regions that play a crucial role in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9095551/

Functional and clinical outcomes of FMRI-based ... This study investigates the application of real-time functional MRI (rtfMRI) neurofeedback (NF) to foster resistance towards craving-related neural activation ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-018-1604-3

The SyBil-AA real-time fMRI neurofeedback study The results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback training in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763424003348

Real-time fMRI-based neurofeedback to restore brain ... fMRI-neurofeedback has been used to target brain dysfunction in substance use disorders (SUDs) and to reduce craving, but a systematic synthesis of up-to-date ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02406456

Optimisation of Functional MRI-based Neurofeedback for ... History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5048603/

Neurofeedback training for alcohol dependence versus ... Preliminary results suggest that it can help patients to control their symptoms. This study uses rtfMRI NFT for relapse prevention in alcohol dependence.

8. withpower.com withpower.com/trial/phase-alcohol-drinking-8-2018-e6a16

Neurofeedback for Alcohol Use Disorder · Info for Participants Real-time fMRI neurofeedback has been used in studies with humans, including those with alcohol use disorder, without reports of significant safety concerns. It ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2213158220303338

A systematic review of fMRI neurofeedback reporting and ... Real-time fMRI-based neurofeedback is a relatively young field with a potential to impact the currently available treatments of various disorders. In order ...