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

Trial Summary

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.

What data supports the effectiveness of this treatment for alcoholism?

Research shows that repetitive transcranial magnetic stimulation (rTMS), a part of this treatment, can help reduce cravings and improve attention and executive function in people with alcohol dependence. This suggests that the combined approach of neurofeedback and TMS might be effective in treating alcoholism. ^{1 2 3 4 5}

Is Neurofeedback + TMS safe for humans?

Studies on transcranial magnetic stimulation (TMS) for alcohol dependence suggest it is generally safe, with no significant adverse effects reported. These studies involved stimulating specific brain areas to reduce alcohol cravings and showed promising results without major safety concerns. ^{1 2 5 6 7}

How is the Neurofeedback + TMS treatment for alcoholism different from other treatments?

This treatment is unique because it combines real-time functional MRI neurofeedback (a technique that helps patients control brain activity related to cravings) with transcranial magnetic stimulation (a method that uses magnetic fields to stimulate specific brain areas). This combination aims to modulate brain responses associated with addiction, offering a novel approach compared to traditional therapies. ^{1 3 5 8 9}

What is the purpose of this trial?

The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder. After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.

Research Team

Samantha J Fede, PhD

Principal Investigator

Auburn University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. [2022]

2. Switzerland 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. [2023]

3. England 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. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Reduced intra-individual reaction time variability during a Go-NoGo task in detoxified alcohol-dependent patients after one right-sided dorsolateral prefrontal HF-rTMS session. [2013]

5. India 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cortical inhibition within motor and frontal regions in alcohol dependence post-detoxification: A pilot TMS-EEG study. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Deep TMS on alcoholics: effects on cortisolemia and dopamine pathway modulation. A pilot study. [2015]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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