Skip to main content
OpenTrials
Completed

NCT Number: NCT02621424

Repetitive Transcranial Magnetic Stimulation for Dementia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veterans aged 55 years or older
  • Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease.
  • Ability to obtain a Motor Threshold, determined during the screening process.
  • With an adequately stable condition and living environment to enable attendance at scheduled clinic visits.
  • If on a prescription medication for cognition that medication dose will be stable for at least 4 weeks prior to randomization into the study and participant will be willing to remain on a stable regimen during the acute treatment phase.
  • Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form to be signed by the participant, or a designated legal representative when the participant lacks decision making capacity prior to participating in any study- specific procedures or assessments.

Exclusion criteria

  • Patients with prior exposure to rTMS or electroconvulsive therapy (ECT).
  • Unable to safely withdraw, at least two weeks prior to treatment commencement, from medications 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 patient report or chart review.
  • Active current suicidal intent or plan as determined by patient report or chart review.
  • Current or Prior history of a seizure disorder as determined by patient report or chart 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 for seizure.
  • Not fluent in English or a hearing impairment severe enough to impair comprehension

Treatment and study plan

rTMS

Device

stimulation of the brain with magnetic pulses

SHAM

Device

sham noise to block the sound of stimulation

Primary outcomes

  1. Changes From Baseline CVLT Scores After Treatment and 4 Month Later

    Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

    Changes of California verbal learning test scores (CVLT) from baseline after treatment and 4 months later.

    CVLT is 16 points scoring system. (minimum=0, maximum=16, higher the better memory).

Secondary outcomes

  1. Changes in Boston Naming After Treatment

    Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

    Changes in Boston Naming Test (BNT) from baseline was analyzed. BNT is a 60 points scoring system. (minimum=0, maximum=60, higher the better).

  2. Changes in Plasma BDNF Levels After Treatment

    Time frame: within a week following the last treatment session and 4 months later

    Changes in BDNF plasma levels (pg/ml) from baseline were analyzed after treatment.

    BDNF is a plasma biomarker, minimum=0, no maximum. Higher number means more BDNF synthesis).

  3. Changes in Animal Fluency After Treatment and 4 Months Later

    Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

    Animal Fluency (AF) is a scoring system to assess the ability to generate a list of related words.

    The score is the number of animals the examinee can name in one minute time. (Minimum = 0, No maximum, higher the better).

  4. Changes in Trail Making B Test Score After Treatment and 4 Months Later

    Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

    Trail making B is a scoring system for the assessment of the mental flexibility, processing speed and executive function. The score is the time (in seconds) it takes for the examinee to draw line segments connecting sequentially from 1-A-2-B-3....all the way to12-L-13. (The lower score means faster speed and means better performance. The minimum is (hypothetically) zero. There is no maximum. However, in some test centers, the maximum allowed time is 200 seconds.

  5. Brief Visual Memory Test (BVMT)

    Time frame: assessed at baseline, end of treatment and 4-month post-treatment follow up

    A piece of paper with 6 simple drawings is presented to the subject for 10 seconds. The subject is then asked to draw these drawings from memory. The process is repeated three times to assess visual memory and learning. Each correct drawing scores two pints. Maximum score for three trials is 36. Minimum score is 0. Higher the better.

  6. Montreal Cognitive Assessment (MoCA)

    Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

    MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains:

    • short-term memory (5 points)- two learning trials of five nouns and delayed recall after approximately five minutes.
    • visuospatial abilities - clock-drawing task (3 points) and copy a cube (1 point).
    • executive functions - alternation task abbreviated trail-making B (1 point), and a two-item verbal abstraction task (2 points).
    • attention, concentration, and working memory - a sustained attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each).
    • language - three-item confrontation naming (3 points), repetition of two sentences (2 points), and verbal fluency (1 point).
    • abstract reasoning - describe the similarity of tasks (2 points).
    • orientation to time and place (6 points). Minimum score: 0. Maximum score: 30. Higher the better.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: rTMS for demen

Important dates

Study start
2016
Primary completion
2019
Study completion
2025
First posted
Dec 3, 2015
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.