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tDCS + Language Therapy for Primary Progressive Aphasia
Phase 2
Recruiting
Led By Kyrana Tsapkini, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 50 and 80
Presence of aphasia attributable to non-fluent PPA or logopenic PPA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate follow-up of 3-week intervention period and 3-month follow-up
Awards & highlights
Study Summary
This trial will test the feasibility and effectiveness of tDCS in people with primary progressive aphasia.
Who is the study for?
This trial is for individuals aged 50-80 with non-fluent or logopenic primary progressive aphasia (PPA), who have at least a high school education and can consent to the study. Excluded are those with recent participation in other trials, left-handedness, pregnancy, severe cardiopulmonary disorders, pacemakers, terminal illness, major psychiatric issues that affect study compliance, previous skull breaches, certain MRI exclusions like claustrophobia or metal implants near the eye.Check my eligibility
What is being tested?
The trial tests transcranial direct current stimulation (tDCS) combined with language therapy against a sham tDCS plus language therapy to see if it helps PPA patients. It's a Phase II multi-center clinical trial conducted by Johns Hopkins University, University of Pennsylvania and University of Toronto.See study design
What are the potential side effects?
tDCS is generally considered safe but may cause mild side effects such as tingling on the scalp where electrodes are placed, fatigue after treatment sessions or slight itching under electrode pads during stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 80 years old.
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I have speech difficulties due to specific brain conditions.
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I understand the study and can agree to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate follow-up of 3-week intervention period and 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate follow-up of 3-week intervention period and 3-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Letter Accuracy at 3-month follow-up visit
Change in Phonemic Accuracy at 3-month follow-up visit
Immediate Change in Letter Accuracy
+1 moreSecondary outcome measures
Change in Untrained Naming Items (letter accuracy)
Change in Untrained Naming Items (phonemic accuracy)
Change in functional connectivity of select brain regions (z-correlations)
Other outcome measures
Bilingualism as assessed by the Language Experience and Proficiency Questionnaire
Change in Rey Auditory-Verbal Learning Test (RAVLT) score
Change in anisotropy of white matter tracts of select brain regions
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS + Language Therapy firstExperimental Treatment2 Interventions
Active tDCS will be applied at the beginning of 45 minutes language therapy session and will last for 20 minutes.
Group II: Sham tDCS + Language Therapy firstPlacebo Group2 Interventions
Sham tDCS will be applied at the beginning of 45 minutes language therapy session.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,694 Previous Clinical Trials
28,027,085 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,275 Previous Clinical Trials
14,840,458 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50 and 80 years old.You have metal objects in your face or head, except for dental braces, fillings, or implants.You have an illness that is expected to make you very sick and may not live for much longer than a year.I haven't had unexplained fainting or complex seizures in the last 6 months.You have any of the following devices implanted in your body: cardiac pacemaker, insulin pump, nerve stimulator, or similar electronic devices.I am able to understand and consent to medical procedures (my cognitive tests show I'm capable).I have a serious heart, lung, or metabolic condition.I have speech difficulties due to specific brain conditions.You have a pacemaker or implanted defibrillator.I have never had surgery on my skull.I do not have any serious brain or nerve conditions that could make the study unsafe for me.I have had a brain condition like a stroke or injury that affects my brain function.You are pregnant, have claustrophobia, have metal in your eye or orbit, or have tattooed eyeliner (for MRI exclusion).I understand the study and can agree to participate.You have a condition that makes it hard for you to communicate or move.You are currently misusing alcohol or drugs, whether they are prescribed or not.You are left-handed.
Research Study Groups:
This trial has the following groups:- Group 1: Active tDCS + Language Therapy first
- Group 2: Sham tDCS + Language Therapy first
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.
Nonfluent Aphasia Patient Testimony for trial: Trial Name: NCT05386394 — Phase 2
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