← Back to Search

Device

HD-tDCS + mCILT for Primary Progressive Aphasia

Phase 2
Recruiting
Led By Roy H Hamilton, 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
Must be able to understand the nature of the study, and give informed consent
Native English speaker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks
Awards & highlights

Study Summary

This trial is testing whether high-definition transcranial direct current stimulation (HD-tDCS) paired with modified constraint-induced language therapy (mCILT) can improve language performance in people with primary progressive aphasia (PPA). The study will compare changes in language performance and brain imaging before and after receiving 10 semi-consecutive daily sessions of real or sham HD-tDCS + mCILT. The 3-month follow-up will be the primary endpoint.

Who is the study for?
This trial is for native English speakers who can understand the study and consent to participate, diagnosed with nonfluent agrammatic PPA or logopenic variant PPA, and have at least a high school education. It's not for those with skull breaches, other neurological issues like stroke or brain injury, epilepsy/seizures history, pacemakers/ICDs, or small vessel disease.Check my eligibility
What is being tested?
The study tests if language therapy combined with electrical brain stimulation (HD-tDCS) improves language in people with certain types of aphasia. Participants receive real or fake treatments over 10 days and are assessed immediately after and again three months later to see which works better.See study design
What are the potential side effects?
Possible side effects from HD-tDCS may include discomfort at the electrode site on the head, itching, tingling during stimulation sessions, headache, fatigue. These are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I understand the study and can give my consent.
Select...
I am a native English speaker.
Select...
I have been diagnosed with a specific type of language disorder due to PPA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aphasia

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HD-tDCS+mCILTActive Control2 Interventions
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of HD-tDCS for 20 minutes using a montage in which a central electrode (1.5mA) is placed over the left frontotemporal area and four surrounding cathodes (.375mA each). Subjects will participate in a modified constraint-induced language therapy.
Group II: Sham+mCILTPlacebo Group2 Interventions
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham for 20 minutes using a montage in which a central electrode is placed over the left frontotemporal area and four surrounding cathodes. Subjects will participate in a modified constraint-induced language therapy,

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,143 Total Patients Enrolled
Roy H Hamilton, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this research project?

"Yes, the information available on clinicaltrials.gov reveals that this study is actively looking for participants. The trial was created on 8/17/2020 and edited on 9/16/2022. 66 patients are needed from 1 site."

Answered by AI

Are people aged 20 or older able to participate in this drug trial?

"The age range for patients that this trial is looking to enroll falls between 45 and 80 years old."

Answered by AI

Are there any available positions for participants in this experiment?

"The study, which can be found on clinicaltrials.gov, is currently looking for patients to participate. This trial was first posted on August 17th 2020 and the most recent update occurred on September 16th 2020."

Answered by AI

Who would be a qualified participant for this experiment?

"This particular clinical study is accepting 66 individuals that have pick disease of the brain and are between 45-80 years old. Other requirements for interested patients include: the ability to understand and provide informed consent for the nature of the study, being a native English speaker, having a high school level education or higher, and displaying symptoms of aphasia due to nonfluent agrammatic PPA (naPPA) or logopenic variant PPA (lvPPA)."

Answered by AI

Has the FDA cleared HD-tDCS+mCILT for patient use?

"HD-tdcs+mCILT received a safety score of 2 because, while there is data suggesting it is safe, there is no evidence that it is effective."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS
2020. "Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04046991.
All > Aphasia > Frontotemporal Dementia
~3 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top