DementiarTMS for demenNCT02621424

Repetitive Transcranial Magnetic Stimulation for Dementia

A study testing RTMS in people with Dementia and Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 99 years
Conditions the study is for: Dementia, Mild Cognitive Impairment
What is being tested?: RTMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2016to 16 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207

Other trials in United States

About this study

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.

Read the 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.

Conditions: Dementia, Mild Cognitive Impairment
Being tested: RTMS, sham
Keywords: dementia, Mild Cognitive Impairment (MCI), RTMS, CVLT
Medical subject headings: Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RTMSDevice
stimulation of the brain with magnetic pulses
shamDevice
sham noise to block the sound of stimulation

Study groups in NCT02621424
Study group	Role	What they receive
RTMS	Experimental	repetitive transcranial magnetic stimulation Receives: Device: RTMS
sham	Sham comparator	sham noise to block the sound of treatment Receives: Device: sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes From Baseline CVLT Scores After Treatment and 4 Month Later
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).
Measured: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

Secondary outcomes (6)

Changes in Boston Naming After Treatment
Changes in Boston Naming Test (BNT) from baseline was analyzed. BNT is a 60 points scoring system. (minimum=0, maximum=60, higher the better).
Measured: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes in Plasma BDNF Levels After Treatment
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).
Measured: within a week following the last treatment session and 4 months later
Changes in Animal Fluency After Treatment and 4 Months Later
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).
Measured: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes in Trail Making B Test Score After Treatment and 4 Months Later
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.
Measured: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Brief Visual Memory Test (BVMT)
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.
Measured: assessed at baseline, end of treatment and 4-month post-treatment follow up
Montreal Cognitive Assessment (MoCA)
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.
Measured: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201616 Sep 2025

First posted3 Dec 2015 (estimated)
Study start1 Jan 2016
Primary completion28 Feb 2019
Study completion16 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DementiaStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02621424
Sponsor's protocol ID: E1889-P
Other IDs: RX14-009
Acronym: rTMS for demen
Status last verified: Sep 2025
First submitted: 23 Nov 2015
Last updated: 30 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Cheng J, Fairchild JK, McNerney MW, Noda A, Ashford JW, Suppes T, Chao SZ, Taylor J, Rosen AC, Durazzo TC, Lazzeroni LC, Yesavage J. Repetitive Transcranial Magnetic Stimulation as a Treatment for Veterans with Cognitive Impairment and Multiple Comorbidities. J Alzheimers Dis. 2022;85(4):1593-1600. doi: 10.3233/JAD-210349.
PubMed 34958013

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repetitive Transcranial Magnetic Stimulation for Dementia
ClinicalTrials.gov ID: NCT02621424
Acronym / sponsor ID: rTMS for demen / E1889-P
Conditions: Dementia, Mild Cognitive Impairment
Keywords: dementia, Mild Cognitive Impairment (MCI), RTMS, CVLT
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jan 2016 (actual)
Primary completion: 28 Feb 2019 (actual)
Study completion: 16 Sep 2025 (actual)
First posted: 3 Dec 2015 (estimated)
Results: Posted 27 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RTMS	Experimental	Device: RTMSrepetitive transcranial magnetic stimulation
sham	Sham comparator	Device: shamsham noise to block the sound of treatment

Who may qualify

Ages: 55 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RTMSstimulation of the brain with magnetic pulses	Device	RTMS
shamsham noise to block the sound of stimulation	Device	sham

Primary outcome

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).

6 secondary outcomes

Changes in Boston Naming After Treatment
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes in Plasma BDNF Levels After Treatment
Time frame: within a week following the last treatment session and 4 months later
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
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
Brief Visual Memory Test (BVMT)
Time frame: assessed at baseline, end of treatment and 4-month post-treatment follow up
Montreal Cognitive Assessment (MoCA)
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up

Results and safety

Results posted to the registry on 27 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RTMS	14	13
Sham	18	16

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	RTMS n = 13	Sham n = 13
Baseline	8.5 (4.6)	9.4 (3.8)
End of treatment	8.6 (4.3)	8.3 (3.7)
4 month follow up	10.1 (4.1)	9.2 (4.2)

Population analysed: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, one did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year post treartment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RTMS	1 of 14 (7.1%)	0 of 14 (0%)	0 of 14
Sham	2 of 18 (11.1%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34958013Cheng J, Fairchild JK, McNerney MW, Noda A, Ashford JW, Suppes T, Chao SZ, Taylor J, Rosen AC, Durazzo TC, Lazzeroni LC, Yesavage J. Repetitive Transcranial Magnetic Stimulation as a Treatment for Veterans with Cognitive Impairment and Multiple Comorbidities. J Alzheimers Dis. 2022;85(4):1593-1600. doi: 10.3233/JAD-210349.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jauhtai J Cheng, MD principal investigator

VA Palo Alto Health Care System, Palo Alto, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RTMS in people with Dementia and Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02621424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.