Using rTMS to help older adults with alcohol use disorder and mild cognitive impairment

Targeting the Shared Substrates of Alcohol Misuse and Cognitive Impairment: Accelerated RTMS for Older Adults with Alcohol Use Disorder

This study is testing if a brain treatment called rTMS can help older adults with both alcohol problems and mild memory issues to think better and drink less.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Medical University of South Carolina (other)
• Locations: 2 sites (Charleston, South Carolina and 1 other locations)
• Trial ID: NCT05896332 on ClinicalTrials.gov

What this trial studies

This study aims to explore the effects of repetitive transcranial magnetic stimulation (rTMS) on older adults aged 60-85 who have both alcohol use disorder and mild cognitive impairment (MCI). The intervention seeks to improve cognitive function while simultaneously reducing heavy drinking, addressing the intertwined nature of these conditions. Participants will undergo active, open-label iTBS-rTMS treatment, with eligibility criteria focusing on specific cognitive impairments and alcohol consumption patterns. The study is significant as it targets a unique intersection of cognitive decline and alcohol misuse, which has not been previously addressed in clinical interventions.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 60-85 who have a current diagnosis of alcohol use disorder and meet specific neuropsychological criteria for mild cognitive impairment.

Not a fit: Patients with prior diagnoses of dementia or major neurocognitive disorders, as well as those with other substance use disorders or severe psychiatric conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved cognitive function and reduced alcohol consumption in older adults, potentially delaying or preventing progression to dementia.

How similar studies have performed: While there is emerging evidence supporting the use of rTMS for cognitive improvement and reduction of heavy drinking, this specific approach targeting both conditions in older adults is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age 60-85.
* English as a first/primary language.
* Current alcohol use disorder
* Alcohol consumption of at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling;
* Meets actuarial neuropsychological criteria for MCI: ≥2 impaired scores within one cognitive domain, or ≥1 impaired scores in ≥3 domains, where an impaired score is defined as ≤16th percentile using demographically-corrected norms.
* Not pregnant (will administer pregnancy test to confirm)
* Functional visual and auditory acuity to complete all assessments.

Exclusion Criteria:

* Prior diagnosis of Dementia or Major Neurocognitive Disorder per NIA-AA or DSM-5 criteria, and TICS ≤ 22 suggestive of dementia.
* Current substance use disorder other than AUD or nicotine use disorder, bipolar disorder, or schizophrenia spectrum or other psychotic disorder.
* Daily/weekly anticholinergic or sedative use. Stimulants may be allowed pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen of 4 weeks prior to enrollment.
* History of significant or unstable condition/s that may impact cognition such as significant cardiac, cerebrovascular, or metabolic disease, developmental disorder, or other neurologic disease (e.g. movement disorder, moderate to severe brain injury, seizures).
* MRI and TMS contraindications (e.g. implants, claustrophobia, conditions/treatments that lower seizure threshold, taking medications that have short half-lives, no identifiable motor threshold).
* Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days.
* Pregnant (will administer pregnancy test to confirm)

Where this trial is running

Charleston, South Carolina and 1 other locations

• Medical Univeristy of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Lisa McTeague, Ph.D. — Medical University of South Carolina
• Study coordinator: Rhia Walton, M.A.

Conditions: Alcohol Use Disorder, Mild Cognitive Impairment, Transcranial Magnetic Stimulation