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Repetitive Transcranial Magnetic Stimulation for Dementia (rTMS for demen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02621424
Recruitment Status : Active, not recruiting
First Posted : December 3, 2015
Results First Posted : May 27, 2020
Last Update Posted : November 4, 2022
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Mild Cognitive Impairment Device: RTMS Device: sham Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for Dementia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: RTMS
repetitive transcranial magnetic stimulation
Device: RTMS
stimulation of the brain with magnetic pulses

Sham Comparator: sham
sham noise to block the sound of treatment
Device: sham
sham noise to block the sound of stimulation

Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. short-term memory (5 points)- two learning trials of five nouns and delayed recall after approximately five minutes.
    2. visuospatial abilities - clock-drawing task (3 points) and copy a cube (1 point).
    3. executive functions - alternation task abbreviated trail-making B (1 point), and a two-item verbal abstraction task (2 points).
    4. 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).
    5. language - three-item confrontation naming (3 points), repetition of two sentences (2 points), and verbal fluency (1 point).
    6. abstract reasoning - describe the similarity of tasks (2 points).
    7. orientation to time and place (6 points). Minimum score: 0. Maximum score: 30. Higher the better.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621424

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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Jauhtai J Cheng, MD VA Palo Alto Health Care System, Palo Alto, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] January 31, 2020
Statistical Analysis Plan  [PDF] January 31, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02621424    
Other Study ID Numbers: E1889-P
RX14-009 ( Other Grant/Funding Number: VA )
First Posted: December 3, 2015    Key Record Dates
Results First Posted: May 27, 2020
Last Update Posted: November 4, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Mild Cognitive Impairment (MCI)
Additional relevant MeSH terms:
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Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders