Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 45 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Treating Primary Progressive Aphasia (PPA) and Elucidating Neurodegeneration in the Language Network Using Transcranial Direct Current Stimulation (tDCS)

Conditions

Primary Progressive Aphasia

Being tested

high-definition transcranial direct current stimulation, modified constraint-induced language therapy

Keywords

non-invasive brain stimulation, transcranial direct current stimulation (tDCS), aphasia

Medical subject headings

Aphasia, Primary Progressive, Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• high-definition transcranial direct current stimulationDevice

  High definition transcranial direct current stimulation (HD-tDCS) involves the application of low-intensity current through electrodes placed on the scalp. It is believed to elicit brain effects by producing incremental shifts in the resting membrane potential of large numbers of neurons, which alters neuronal firing rates and thus modulates patterns of brain activity in potentially behaviorally-relevant ways. HD-tDCS differs from conventional transcranial direct current stimulation (tDCS) because it employed smaller electrodes configured in such a way as to deliver more focal stimulation of the brain.

• modified constraint-induced language therapyBehavioural

  Modified constraint-induced language therapy (mCILT) is a behavioral language therapy that invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures, as a substitute for spoken output. Other key elements of CILT include massed practice of goal-directed speech and shaping of desired responses by increasing response demands as participants improve. MCILT differs from traditional constraint-induced language therapy (CILT) in three ways: 1) it will be done as an individual therapy with the examiner in the role of a communication partner; 2) treatment will be delivered in short sessions (1 hour rather than a more typical 3-4 hour session); 3) targeting nouns + semantically related verbs to generate noun + verb phrases in treatment, a modification that may be better suited to addressing syntactic structure.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change in Western Aphasia Battery Aphasia Quotient (WAB-AQ)

   The primary outcome measure will be the change in score on the WAB-AQ, a score assessing overall aphasia recovery. Scores can range from 0-100. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.

   Measured: At baseline, immediately after 2 week intervention, 6 and 12 weeks post intervention for HD-tDCS+mCILT and Sham intervention periods.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Aug 2019
2. Study start17 Aug 2020
3. Primary completion30 Jun 2025
4. Study completion30 Jun 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
• More trials run by University of PennsylvaniaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.