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Active Not RecruitingNCT05896332

rTMS in Older Adults With MCI and AUD

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

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
35 (estimated)
Sponsor
Medical University of South Carolina · Academic / Other
Sex
All
Age
60 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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. Notably, there exists no intervention targeting the intersection of alcohol misuse and cognitive dysfunction in older adults. It is unclear whether alcohol contributes to a specific form of Alzheimer's Disease and Related Dementias (ADRD) and furthermore whether the impairments and structural brain changes represent classical ADRD neurodegenerative patterns. Despite the unclear etiopathogenesis, there is emerging evidence that repetitive transcranial magnetic stimulation (rTMS) to upregulate executive/cognitive control circuitry can improve cognition in ADRD, and separately reduce heavy drinking in AUD. Our long-term objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults towards breaking this cycle and thwarting progression to dementia.

Conditions

Interventions

TypeNameDescription
DEVICEActive, Open Label iTBS-rTMSParticipants in this group will receive 10 sessions of iTBS-rTMS per day, 5 days per week for one week (50 sessions total)

Timeline

Start date
2023-11-01
Primary completion
2026-06-30
Completion
2026-06-30
First posted
2023-06-09
Last updated
2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05896332. Inclusion in this directory is not an endorsement.