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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
933 Previous Clinical Trials
7,394,601 Total Patients Enrolled
46 Trials studying Alcoholism
5,070 Patients Enrolled for Alcoholism
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,815 Total Patients Enrolled
29 Trials studying Alcoholism
6,966 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,410 Total Patients Enrolled
424 Trials studying Alcoholism
985,833 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently signed up for this investigation?

"Affirmative. Records on clinicaltrials.gov demonstrate that this research endeavour, initially posted November 1st 2023, is actively looking for volunteers to join the study. A total of 35 individuals are required at two separate medical facilities."

Answered by AI

What risks come with undergoing Active, Open Label iTBS-rTMS therapy?

"A score of 1 was assigned to Active, Open Label iTBS-rTMS due to the limited evidence in support of its safety and efficacy. This is a Phase 1 trial after all."

Answered by AI

Am I eligible to be an enrollee in this research endeavor?

"This clinical trial seeks 35 participants aged 60 to 85 who have an alcohol use disorder. Furthermore, they must demonstrate adequate visual and auditory acuity as well as first language fluency in English. Patients additionally need to prove that they consume a minimum of 4 drinks per week over the course of 30 days prior to enrolment with evidence of mild cognitive impairment through neuropsychological assessment scores no greater than 16th percentile on demographically adjusted norms. Finally, women applicants will be required to take a pregnancy test before being accepted into the study."

Answered by AI

Are researchers actively looking for participants to join this research endeavor?

"Per the information hosted on clinicaltrials.gov, this research is actively inviting participants to join their trial. This investigation was first listed on November 1st 2023 and has seen a recent update on November 6th of the same year."

Answered by AI

Is this experiment admitting participants who are older than forty?

"Qualified participants must be between 60 to 85 years old. There are 66 trials for young adults and 873 studies open to elderly individuals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
rTMS in Older Adults With MCI and AUD
Lisa McTeague, PhD 2023. "rTMS in Older Adults With MCI and AUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05896332.
~23 spots leftby Jul 2025
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