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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
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I understand the study and can give my consent.
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I am a native English speaker.
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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,

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,022 Previous Clinical Trials
42,879,314 Total Patients Enrolled
Roy H Hamilton, MDPrincipal InvestigatorUniversity of Pennsylvania
~14 spots leftby Jun 2025
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