Large-coil Parietal Repetitive Transcranial Magnetic Stimulation (rTMS) for Alzheimer Disease (AD)

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06597942
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Alzheimer Disease
  • Alzheimer&Amp;#39;s Dementia
  • Alzheimer&Amp;#39;s Disease (AD)
  • Alzheimer&Amp;Amp;#39;s Disease
  • Dementia Alzheimer Type
  • Mild Alzheimer&Amp;Amp;#39;s Disease
  • Moderate Alzheimer&Amp;Amp;#39;s Disease

Eligibility Criteria

Sex
ALL
Age
55 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS — DEVICE
    rTMS Stimulation Parameters Pulse count: 1600 pulses Frequency: 20Hz Pules per train: 40 pulses Inter-train interval: 20 seconds (28s originally) Intensity: 100% Motor Threshold (depth-corrected from MRI) Target: Precuneus using structural MRI navigation with MNI coordinates
  • Transcranial Magnetic Stimulation Sham — DEVICE
    Sham coil placed in same location and set with same parameters as active treatment coil. However, this device will not output active treatment and scalp electrodes will mimic the sensation of rTMS for the participant.

Study Details

The goal of this clinical trial is to learn if using large-coil (or "deep") repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus and surrounding areas is feasible, tolerable, and potentially efficacious for memory in Alzheimer's Disease. Previous work studying rTMS in Alzheimer's is mixed, but recent work studying rTMS of the precuneus is encouraging for both its short-term and long-term effects. The main questions this study aims to answer are: * Is deep rTMS of the precuneus feasible and tolerable in Alzheimer's? * Are there signs of positive brain changes in response to deep rTMS? * Is deep rTMS potentially efficacious for memory in Alzheimer's? Researchers will compare active stimulation to placebo stimulation while obtaining memory testing and measurements of the brain (imaging, scalp electrode measurements, bloodwork) to see if active treatment works to treat Mild Cognitive Impairment (MCI) and mild-to-moderate dementia due to Alzheimer's disease. Participants will: * Engage with memory testing, brain scans, and bloodwork during a comprehensive assessment * Visit the clinic 3 times for 12 consolidated rTMS sessions, followed by 8 once weekly maintenance visits * Be offered a full open-label active treatment course after completing their treatment course if they are initially in the placebo group

Key Dates

First listed
Sep 19, 2024
Start date
Oct 17, 2024
Status verified
Sep 2026
Primary completion
Oct 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Open-Label Active deep rTMS (First Study Stage)
    The first stage of the study will consist of protocol refinement. In this first stage of 5-10 participants, all participants will receive open-label active treatment. Treatment will consist of 16 sessions of deep rTMS spread over 5 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 60 minutes between sessions), followed by 1 session per week for 4 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 28 second intertrain interval (roughly 20 minutes per session).
  • Experimental: Randomized Active deep precuneus rTMS
    The second stage of the study will consist of both active and sham treatment groups. Treatment will consist of 28 sessions of deep rTMS spread over 9 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 30-60 minutes between sessions), followed by 1 visit per week (with two sessions per visit separated by 30-60 minutes) for 8 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 20 second intertrain interval (roughly 15-20 minutes per session). The active group will receive this protocol using an active treatment coil delivering real rTMS.
  • Sham Comparator: Randomized Sham deep precuneus rTMS
    The second stage of the study will consist of both active and sham treatment groups. Treatment will consist of 28 sessions of deep rTMS spread over 9 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 30-60 minutes between sessions), followed by 1 visit per week (with two sessions per visit separated by 30-60 minutes) for 8 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 20 second intertrain interval (roughly 15-20 minutes per session). The placebo group will receive this protocol using a sham TMS coil delivering inactive rTMS. Participants in the sham/placebo group will be offered a full open-label extension treatment course of active rTMS on completion of the randomized phase.

Primary Outcome Measure

Completion Rate [ Time Frame: From enrollment to the end of treatment after 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA TMS Clinical and Research ServiceLos AngelesCalifornia90095
Cole Matthews, BA
[email protected]
(310) 825-7797
Doan Ngo, BS
[email protected]
(310) 825-7797
Michael Leuchter, MD (PRINCIPAL_INVESTIGATOR)

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