Repetitive Transcranial Magnetic Stimulation for Dementia

NCT02621424 | Completed Results DMC FDA Device

• 2 other identifiers: E1889-PRX14-009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Mild Cognitive Impairment

Keywords

dementia; Mild Cognitive Impairment (MCI); RTMS; CVLT

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (6)

• Changes in Boston Naming After Treatment

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

• Changes in Plasma BDNF Levels After Treatment

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

• Changes in Animal Fluency After Treatment and 4 Months Later

  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

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

• Brief Visual Memory Test (BVMT)

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

Study Arms (2)

RTMS

EXPERIMENTAL

repetitive transcranial magnetic stimulation

Device: RTMS

sham

SHAM COMPARATOR

sham noise to block the sound of treatment

Device: sham

Interventions

RTMS DEVICE

stimulation of the brain with magnetic pulses

RTMS

sham DEVICE

sham noise to block the sound of stimulation

sham

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (1)

• 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.

  PMID: 34958013 DERIVED

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Jauhtai Cheng, MD, Staff Neurologist
• Organization: VA Palo Alto

jauhtai.cheng2@va.gov

650-493-5000

Study Officials

• Jauhtai J Cheng, MD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2016
• Primary Completion: February 28, 2019
• Study Completion: September 16, 2025
• Last Updated: September 30, 2025
• Results First Posted: May 27, 2020

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)