Repetitive Transcranial Magnetic Stimulation for Dementia

Last updated: September 17, 2025
Sponsor: VA Office of Research and Development
Overall Status: Completed

Phase

N/A

Condition

Alzheimer's Disease

Memory Problems

Dementia

Treatment

sham

RTMS

Clinical Study ID

NCT02621424
E1889-P
RX14-009
  • Ages 55-99
  • All Genders

Study Summary

The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Veterans aged 55 years or older

  • Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer'sdisease.

  • Ability to obtain a Motor Threshold, determined during the screening process.

  • With an adequately stable condition and living environment to enable attendance atscheduled clinic visits.

  • If on a prescription medication for cognition that medication dose will be stablefor at least 4 weeks prior to randomization into the study and participant will bewilling to remain on a stable regimen during the acute treatment phase.

  • Able to read, verbalize understanding, and voluntarily sign the Informed ConsentForm to be signed by the participant, or a designated legal representative when theparticipant lacks decision making capacity prior to participating in any study-specific procedures or assessments.

Exclusion

Exclusion Criteria:

  • Patients with prior exposure to rTMS or electroconvulsive therapy (ECT).

  • Unable to safely withdraw, at least two weeks prior to treatment commencement, frommedications that substantially increase the risk of having seizures.

  • Have a cardiac pacemaker or a cochlear implant.

  • Have an implanted device deep brain stimulation or metal in the brain

  • Current substance abuse not including caffeine or nicotine as determined by patientreport or chart review.

  • Active current suicidal intent or plan as determined by patient report or chartreview.

  • Current or Prior history of a seizure disorder as determined by patient report orchart review

  • Traumatic brain injury within the last two months

  • Participation in another concurrent interventional clinical trial

  • Known current psychosis as determined by patient report or chart review.

  • Current or prior history of a mass lesion, cerebral infarct or other non-cognitive,active central nervous system (CNS) disease that would increase the risk forseizure.

  • Not fluent in English or a hearing impairment severe enough to impair comprehension

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: sham
Phase:
Study Start date:
January 01, 2016
Estimated Completion Date:
September 16, 2025

Study Description

The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that:

  • 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that

  • 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.

Connect with a study center

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California 94304-1207
    United States

    Site Not Available

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto 5380748, California 5332921 94304-1207
    United States

    Site Not Available

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