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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 (1 week pre-treatment), week 2 (immediately post-treatment), week 6 (4 weeks post-treatment)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out