rTMS for Mild Cognitive Impairment and Alcoholism
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Anticholinergics, Sedatives
Disqualifiers: Dementia, Bipolar, Schizophrenia, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.
Will I have to stop taking my current medications?
The trial requires that you stop using daily or weekly anticholinergic or sedative medications. However, you can continue taking cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants if you have been on a stable dose for at least 4 weeks before joining the trial.
What data supports the effectiveness of this treatment for mild cognitive impairment and alcoholism?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can reduce alcohol cravings and intake in people with alcohol use disorder. Studies have found that rTMS affects brain areas linked to craving and attention, suggesting it might help manage symptoms in alcohol-dependent patients.
12345Is rTMS safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, as it is a non-invasive and painless method. However, there is a potential risk of inducing seizures, so safety guidelines are recommended to minimize this risk.
12567How does the treatment rTMS for Mild Cognitive Impairment and Alcoholism differ from other treatments?
rTMS (repetitive transcranial magnetic stimulation) is unique because it uses magnetic fields to stimulate specific areas of the brain, potentially reducing alcohol cravings and intake by affecting brain circuits related to addiction. Unlike traditional treatments, it is non-invasive and focuses on altering brain activity rather than using medication.
458910Eligibility Criteria
This trial is for older adults aged 60-85 who have mild cognitive impairment (MCI) and struggle with alcohol use disorder. They must be heavy drinkers, as defined by specific amounts per week, speak English fluently, and have good vision and hearing to participate in assessments. Pregnant individuals are excluded.Inclusion Criteria
I have had 4 or more heavy drinking days each week in the last month.
English as a first/primary language
I am between 60 and 85 years old.
+4 more
Exclusion Criteria
Current substance use disorder other than AUD or nicotine use disorder, bipolar disorder, or schizophrenia spectrum or other psychotic disorder
I have been diagnosed with dementia or a major thinking/memory disorder.
I use certain daily medications, but my treatment plan has been stable for the last 4 weeks.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Treatment
Participants receive 10 sessions of iTBS-rTMS per day, 5 days per week for one week (50 sessions total)
1 week
5 visits (in-person)
Post-treatment Assessment
Clinical assessments and brain MRI at 1-week post-treatment, with weekly online self-report assessments up to four weeks
4 weeks
1 visit (in-person), weekly online assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The study tests a treatment called iTBS-rTMS which is an active form of brain stimulation therapy. It's open label, meaning everyone knows they're getting the real treatment. The goal is to see if it can help reduce heavy drinking while also improving memory and thinking skills in older adults.
1Treatment groups
Experimental Treatment
Group I: Active, Open Label iTBS-rTMSExperimental Treatment1 Intervention
Individuals will receive 10 sessions of iTBS-rTMS per day, 5 days per week for one week (50 sessions total). All will undergo clinical assessments and brain MRI at pre-treatment and at 1-week post-treatment, and clinical assessments at 4-weeks post-treatment. Weekly post-treatment online self-report assessments will be collected up to four weeks. Resting-state parcellations of pre- and post-fMRI will be completed for personalized targeting and network parcellations.
Active, Open Label iTBS-rTMS is already approved in United States, United States, European Union for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Treatment-resistant depression
- Obsessive-compulsive disorder (OCD)
- Migraines
- Anxiety with depression
- Smoking dependence
- Bipolar depression
- Depression in adolescents 15 years and older
🇺🇸 Approved in United States as Deep TMS for:
- Obsessive-compulsive disorder (OCD)
- Smoking cessation
- Major depressive disorder (MDD)
🇪🇺 Approved in European Union as Deep TMS for:
- Obsessive-compulsive disorder (OCD)
- Smoking cessation
- Major depressive disorder (MDD)
- Additional mental health and neurological conditions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
Medical Univeristy of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Institutes of Health (NIH)Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. [2022]To study the anticraving efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the right dorsolateral pre-frontal cortex (DLPFC) in patients with alcohol dependence.
Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Visual Selective Attention in Male Patients With Alcohol Use Disorder After the Acute Withdrawal. [2023]To investigate the effect of high-frequency repetitive transcranial magnetic stimulation (rTMS) on attention cue reactivity in male patients with alcohol use disorder (AUD) after acute withdrawal.
Accelerated HF-rTMS Protocol has a Rate-Dependent Effect on dACC Activation in Alcohol-Dependent Patients: An Open-Label Feasibility Study. [2016]The application of accelerated high-frequency (HF) repetitive transcranial magnetic stimulation (rTMS) could be a potential treatment option for alcohol-dependent patients and may result in a faster clinical response. In this open-label HF-rTMS feasibility study, we wanted to replicate previous findings of baseline brain activation as a predictor of relapse, and to evaluate how this intervention influences the relapse neurocircuit of "treatment-seeking" alcohol-dependent patients, by means of functional magnetic resonance imaging (fMRI) cue-exposure paradigms. Because relapsing patients have a diminished resilience of the emotion regulation/cognitive control system, before HF-rTMS treatment, we expected lower neuronal activation of especially the ventromedial prefrontal cortex and anterior cingulate cortex (ACC) during the presentation of alcohol-related cues in these patients. The relapse neurocircuit should be modified after accelerated HF-rTMS treatment, only in those patients who did not relapse.
Deep Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex in Alcohol Use Disorder Patients: Effects on Dopamine Transporter Availability and Alcohol Intake. [2018]Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing craving and alcohol intake. We investigated alcohol intake and dopamine transporter (DAT) availability by Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and after deep rTMS. Fourteen patients underwent baseline clinical and SPECT assessment. Eleven out of fourteen patients were randomized into two groups for the REAL (n.5) or SHAM (n.6) treatment. Clinical and SPECT evaluations were then carried out after four weeks of rTMS sessions (T1). At baseline, AUD patients showed higher striatal DAT availability than healthy control subjects (HC). Patients receiving the REAL stimulation revealed a reduction in DAT availability at T1, whereas the SHAM-treated group did not. In addition, patients receiving the REAL stimulation had a decrease in alcohol intake. The results of this longitudinal pilot study may suggest a modulatory effect of deep rTMS on dopaminergic terminals and a potential clinical efficacy in reducing alcohol intake in AUD patients. Further investigations are required to confirm these preliminary data.
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]The aim of this study is to study the effects of repetitive transcranial magnetic stimulation (rTMS) therapy over the left dorsolateral prefrontal cortex (DLPFC) in craving in drug-naive male inpatients of alcohol dependence syndrome.
Acute and chronic effects of ethanol on cortical excitability. [2018]We designed this study to find out whether 5Hz repetitive transcranial magnetic stimulation (rTMS) would disclose changes in cortical plasticity after acute intake of ethanol and in patients with chronic alcohol consumption.
[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]Repetitive magnetic stimulation (rTMS) is a non-invasive, painless method to induce transient activation in circumscript regions of the human cortex. In contrast to TMS with single pulses rTMS allows a more effective stimulation of association cortex and temporary interference with the proper functioning of stimulated areas. Possible applications for examination of the functional anatomy of language lateralisation, memory functions and visual perception are discussed. Possible therapeutic for movement disorders and depression are discussed. On the basis of theoretical considerations and current experience rTMS induced epileptogenic effects are discussed and safety recommendations are given.
Repetitive transcranial magnetic stimulation: Re-wiring the alcoholic human brain. [2020]Alcohol use disorders (AUDs) are one of the leading causes of mortality and morbidity worldwide. In spite of significant advances in understanding the neural underpinnings of AUDs, therapeutic options remain limited. Recent studies have highlighted the potential of repetitive transcranial magnetic stimulation (rTMS) as an innovative, safe, and cost-effective treatment for AUDs. Here, we summarize the fundamental principles of rTMS and its putative mechanisms of action via neurocircuitries related to alcohol addiction. We will also discuss advantages and limitations of rTMS, and argue that Hebbian plasticity and connectivity changes, as well as state-dependency, play a role in shaping some of the long-term effects of rTMS. Visual imaging studies will be linked to recent clinical pilot studies describing the effect of rTMS on alcohol craving and intake, pinpointing new advances, and highlighting conceptual gaps to be filled by future controlled studies.
Direct recording of the output of the motor cortex produced by transcranial magnetic stimulation in a patient with cerebral cortex atrophy. [2019]To examine the descending motor activity evoked by transcranial magnetic stimulation (TMS) in a chronic alcoholic patient with a slight atrophy of the peri-central cortex and compare with that observed in neurologically intact subjects.
Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. [2020]Repetitive transcranial magnetic stimulation (rTMS) is increasingly used as an intervention for treating substance dependence. We aimed to assess evidence of the anti-craving and consumption-reducing effects of rTMS in patients with alcohol, nicotine and illicit drug dependence.