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tDCS + Speech-Language Therapy for Aphasia
N/A
Waitlist Available
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
Must be clinically diagnosed with nfvPPA or unclassifiable PPA. Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment.
Be older than 18 years old
Must not have
Inability to follow directions for baseline tasks.
Stroke/other premorbid neurological disorder affecting the brain.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before intervention, immediately after intervention, 2 weeks post intervention and 2 months post intervention
Summary
This trial is testing whether using transcranial direct current stimulation in combination with language therapy can help improve language abilities in people with primary progressive aphasia.
Who is the study for?
This trial is for right-handed English speakers with at least a 9th grade education, diagnosed with non-fluent variant primary progressive aphasia (nfvPPA) or unclassifiable PPA. Participants must be able to follow directions and not have severe language impairment, other neurological disorders, other language-based learning disorders, or uncorrected visual/hearing impairments.
What is being tested?
The study tests if brain stimulation called transcranial direct current stimulation (tDCS), when combined with speech-language therapy, helps people with nfvPPA speak better than just therapy alone. It looks at immediate improvements in language performance and checks if these benefits last up to two months after treatment.
What are the potential side effects?
While the document does not specify side effects of tDCS directly, common ones can include mild tingling, itching or discomfort at the electrode sites on the scalp during stimulation. Serious side effects are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of language disorder based on tests and MRI.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can follow directions for basic tasks.
Select...
I have had a stroke or another brain disorder before.
Select...
I have a language-based learning disorder, but it's not PPA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before intervention, immediately after intervention, 2 weeks post intervention and 2 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before intervention, immediately after intervention, 2 weeks post intervention and 2 months post intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in segmental duration of consonants of trained words
Change in segmental duration of consonants of untrained words
Change in segmental duration of vowels of trained words
+3 moreSecondary study objectives
Change in anisotropy of white matter tracts of select brain regions
Change in digit span backward score
Change in digit span forward score
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS plus Speech-Language Therapy firstExperimental Treatment2 Interventions
Active tDCS will be applied at the beginning of 45 minutes speech-language therapy session and then participant will be switched to sham tDCS after a washout period.
Group II: Sham plus Speech-Language Therapy firstPlacebo Group2 Interventions
Sham will be applied at the beginning of 45 minutes speech-language therapy session and then participant will be switched to an active tDCS after a washout period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tDCS plus Speech-Language Therapy
2018
N/A
~10
Sham plus Speech-Language Therapy
2013
N/A
~70
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,669 Total Patients Enrolled
Kyrana Tsapkini, PhDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow directions for basic tasks.I have been diagnosed with a specific type of language disorder based on tests and MRI.Your ability to speak and understand language is severely impaired, as shown by a specific test score.You use your right hand for most tasks.You have not corrected your vision or hearing problems.I have had a stroke or another brain disorder before.I have a language-based learning disorder, but it's not PPA.
Research Study Groups:
This trial has the following groups:- Group 1: Active tDCS plus Speech-Language Therapy first
- Group 2: Sham plus Speech-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.
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