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Behavioural Intervention
RTMS for Dementia (rTMS for demen Trial)
N/A
Waitlist Available
Led By Jauhtai J Cheng, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veterans aged 55 years or older diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease
Be older than 18 years old
Must not have
Current or Prior history of a seizure disorder 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within a week following the last treatment session and 4 months later
Summary
This trial will study if magnetic stimulation can improve thinking skills in patients with neurodegenerative conditions that cause mild to moderate cognitive impairment, which can lead to dementia.
Who is the study for?
This trial is for veterans aged 55 or older with mild to moderate cognitive impairment or dementia likely due to Alzheimer's, who can attend clinic visits and have stable medication doses. They must be able to consent and not have pacemakers, cochlear implants, metal in the brain, seizure risks, severe hearing issues, active CNS diseases increasing seizure risk, recent traumatic brain injury or current psychosis.
What is being tested?
The study tests whether repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions leading to dementia. It also examines if the severity of initial cognitive impairment affects rTMS response. Participants are randomly assigned to receive either rTMS or a sham (placebo-like) procedure.
What are the potential side effects?
While specific side effects of rTMS aren't detailed here, common ones include headaches, scalp discomfort at the treatment site during stimulation sessions; rare but serious side effects may include seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran aged 55 or older with Mild Cognitive Impairment or Alzheimer's.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures.
Select...
I have a brain condition that could increase my risk of seizures.
Select...
I have previously undergone rTMS or electroconvulsive therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within a week following the last treatment session and 4 months later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within a week following the last treatment session and 4 months later
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes From Baseline CVLT Scores After Treatment and 4 Month Later
Secondary study objectives
Brief Visual Memory Test (BVMT)
Changes in Animal Fluency After Treatment and 4 Months Later
Changes in Boston Naming After Treatment
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RTMSExperimental Treatment1 Intervention
repetitive transcranial magnetic stimulation
Group II: shamPlacebo Group1 Intervention
sham noise to block the sound of treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RTMS
2019
N/A
~20
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,834 Total Patients Enrolled
23 Trials studying Dementia
3,997 Patients Enrolled for Dementia
Jauhtai J Cheng, MDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.I can read and understand the consent form and agree to participate in the study.I have a brain condition that could increase my risk of seizures.I am a veteran aged 55 or older with Mild Cognitive Impairment or Alzheimer's.My medication for cognition has been stable for 4 weeks and I can keep it the same during the study.I have previously undergone rTMS or electroconvulsive therapy.I cannot stop taking my seizure-risk medication before starting treatment.
Research Study Groups:
This trial has the following groups:- Group 1: RTMS
- Group 2: sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.