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Procedure

rTMS for Mild Cognitive Impairment and Alcoholism

Phase 1
Recruiting
Led By Lisa McTeague, Ph.D.
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (1 week pre-treatment), week 2 (immediately post-treatment), week 6 (4 weeks post-treatment)
Awards & highlights

Study Summary

This trial seeks to optimize rTMS treatment to reduce drinking & cognitive decline caused by alcohol misuse, which contributes to 10% of early-onset dementia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, rTMS treatments may commonly cause headaches or discomfort at the stimulation site. Some people might feel lightheaded or experience brief twitching of facial muscles during the procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (1 week pre-treatment), week 2 (immediately post-treatment), week 6 (4 weeks post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (1 week pre-treatment), week 2 (immediately post-treatment), week 6 (4 weeks post-treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite
Change in Network Functional Connectivity between and among cognitive and reward networks and other networks
Change in Subjective Drinking

Trial Design

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.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,959 Total Patients Enrolled
46 Trials studying Alcoholism
5,070 Patients Enrolled for Alcoholism
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,411 Total Patients Enrolled
29 Trials studying Alcoholism
6,966 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
812 Previous Clinical Trials
1,158,402 Total Patients Enrolled
428 Trials studying Alcoholism
778,322 Patients Enrolled for Alcoholism
~21 spots leftby Jul 2025
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