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Transcranial Magnetic Stimulation
TMS + CILT for Alzheimer's Disease
Phase 1
Waitlist Available
Led By H. Branch Coslett, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of mild-moderate AD as defined by the National Institute of Aging - Alzheimer's Disease and Related Disorders Association criteria
Must be a native English speaker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months post-treatment
Awards & highlights
Study Summary
This trial will test whether transcranial magnetic stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) can improve verbal communication in patients with Alzheimer Disease (AD).
Who is the study for?
This trial is for right-handed, native English speakers with mild to moderate Alzheimer's Disease (AD), having MMSE scores between 23 and 15. Participants must understand the study and consent. Excluded are those with a history of stroke, seizure, other major neurological diseases, significant depression or medical conditions that may interfere with the study.Check my eligibility
What is being tested?
The trial tests if Transcranial Magnetic Stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) can improve verbal communication in AD patients more effectively than sham TMS plus CILT. It also uses advanced neuroimaging to explore how this treatment works.See study design
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however these are generally rare. The specifics of any additional side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild to moderate Alzheimer's disease.
Select...
I am a native English speaker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in WAB-AQ
Secondary outcome measures
Change in PNT
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active TMSActive Control2 Interventions
There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
Group II: Sham TMSPlacebo Group2 Interventions
There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,015 Previous Clinical Trials
42,873,996 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,197 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
331 Previous Clinical Trials
178,457 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have some problems with memory and thinking, as shown by your MMSE score between 23 and 15.I do not have any major health issues that could stop me from completing the study.I have been diagnosed with mild to moderate Alzheimer's disease.I do not have a history of significant neurological diseases like ALS.You have severe depression as determined by a specific test called the Geriatric Depression Scale.I am a native English speaker.I don't have uncontrolled seizures, previous brain surgery, or tinnitus.I have had a stroke in the past.I have had seizures in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Active TMS
- Group 2: Sham TMS
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.
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