tDCS + Language Therapy for Primary Progressive Aphasia

(PPA Trial)

Overseen By Aneta Kielar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Epilepsy, Parkinson's, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with Primary Progressive Aphasia (PPA), a condition that affects language abilities. Researchers are testing whether combining language therapy with transcranial direct current stimulation (tDCS) can improve communication. They seek to determine if this approach can help the brain work around damaged areas. Participants should have a PPA diagnosis, experience language difficulties due to the condition, and be native English speakers or equivalent. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment strategies for PPA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these non-invasive brain stimulation techniques are safe for treating language impairment in Primary Progressive Aphasia?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe when combined with language therapy. Studies have found that tDCS can significantly enhance language skills in individuals with conditions like Primary Progressive Aphasia (PPA). Some individuals might experience mild skin sensations, such as tingling, but these sensations typically dissipate quickly and are not harmful.

tDCS is a non-invasive method, meaning it does not involve surgery or entering the body, making it easier for individuals to tolerate. Research indicates that combining tDCS with speech-language therapy is feasible and can be safely conducted at home. However, larger studies are needed to fully confirm these findings.

Overall, current evidence supports that tDCS is well-tolerated and can safely aid in improving language skills in individuals with PPA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial direct current stimulation (tDCS) combined with language therapy for primary progressive aphasia because it offers a new way to enhance brain function directly. Unlike traditional speech-language therapies that rely solely on practice and repetition, tDCS uses mild electrical currents targeted precisely, as identified by brain scans, to stimulate specific brain areas. This method could potentially boost the brain's ability to rewire and recover language skills more effectively, offering hope for faster and more significant improvements in communication abilities.

What evidence suggests that tDCS combined with language therapy is effective for treating Primary Progressive Aphasia?

Research has shown that transcranial direct current stimulation (tDCS) can improve language skills in individuals with Primary Progressive Aphasia (PPA). In this trial, participants will receive either active tDCS or sham tDCS, both alongside language therapy. Studies have found that active tDCS, when combined with language therapy, enhances performance on naming tasks immediately and for up to two months afterward. Participants using active tDCS have demonstrated better language improvements compared to those receiving only language therapy. This treatment is also considered safe and easy to tolerate, making it a promising option for those with language difficulties due to PPA. ^{1 6 7 8 9}

Who Is on the Research Team?

Aneta Kielar, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with Primary Progressive Aphasia or related conditions, who have normal or corrected-to-normal hearing and vision, and a speech-language deficit due to PPA. They must be native English speakers or equivalent. It's not for those with certain neurological disorders like epilepsy, metallic implants, severe diseases like renal failure, psychiatric issues affecting communication, recent brain surgery, pregnancy, substance abuse problems, or a family history of seizures.

Inclusion Criteria

I have been diagnosed with PPA by a specialist.

My hearing is good.

I have speech or language problems due to primary progressive aphasia.

Exclusion Criteria

You use too much alcohol or drugs.

Your close family members have a history of epilepsy or other seizure disorders.

I have had seizures in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Baseline language testing and EEG-ERP session

1 week

1 visit (in-person)

fMRI Session

fMRI session to determine the most effective treatment site for tDCS

1 week

1 visit (in-person)

Treatment Part 1

tDCS with language treatment administered 5 days a week

2 weeks

10 visits (in-person)

Rest Period and Post-Treatment Assessment

Rest period followed by post-treatment assessment

2 weeks

1 visit (in-person)

Treatment Part 2

tDCS with language treatment administered 5 days a week

2 weeks

10 visits (in-person)

Rest Period and Post-Treatment Assessment 2

Rest period followed by second post-treatment assessment

2 weeks

1 visit (in-person)

Follow-up

2-month follow-up with language assessment, MRI scan, and EEG-ERP session

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Language Therapy
• tDCS

Trial Overview The study tests whether combining language therapy with transcranial direct current stimulation (tDCS), which is non-invasive brain stimulation (NBS), can improve language functions in people with PPA. Participants will either receive the real tDCS treatment alongside language therapy or a sham (fake) version of tDCS plus the same therapy.

How Is the Trial Designed?

Group I: active TDCS Experimental Treatment 1 Intervention

During intervention excitatory/anodal tDCS will be administered alongside speech-language therapy 5 days a week for 2 weeks. The exact location of the stimulation and electrode configuration will be targeted individually based on the optimal site identified in fMRI. TDCS will be administered with NeurConn1 Channel DC- Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes using sponge electrodes with a 30-s ramp-up and ramp-down period

Group II: sham TDCS Placebo Group 1 Intervention

The sham will be administered alongside speech-language therapy 5 days a week for 2 weeks. For sham, stimulation will be ramped up and then down to 0 milliamperes (mA) in the first minute of stimulation. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

In a trial involving six patients with non-fluent primary progressive aphasia, two weeks of daily transcranial direct current stimulation (tDCS) led to improvements in speech production and grammatical comprehension.

The study suggests that tDCS could be a promising intervention for enhancing language abilities in PPA, warranting further research with larger, controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for the treatment of primary progressive aphasia: An open-label pilot study. Gervits, F., Ash, S., Coslett, HB., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) shows promise in improving language outcomes for patients with Primary Progressive Aphasia (PPA), but the effectiveness can vary based on patient characteristics and stimulation protocols, as analyzed in 15 studies.

Despite generally positive results across studies, significant variability exists in treatment effects related to the specific PPA variant and stimulation parameters, indicating that further research is needed to optimize tDCS protocols for different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Transcranial Direct Current Stimulation in Primary Progressive Aphasia: Methodological Considerations. Coemans, S., Struys, E., Vandenborre, D., et al.[2022]

Transcranial direct current stimulation (tDCS) shows promise as an adjunct treatment for improving speech-language deficits in patients with chronic post-stroke aphasia and primary progressive aphasia, by enhancing cortical excitability in language areas.

Current research emphasizes the need for more studies to connect improvements in neuropsychological test performance with real-world functional communication outcomes, as most existing studies focus on impairment rather than practical communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in post stroke aphasia and primary progressive aphasia: Current knowledge and future clinical applications. Sebastian, R., Tsapkini, K., Tippett, DC.[2019]

In a study involving individuals with Primary Progressive Aphasia (PPA), transcranial direct current stimulation (tDCS) showed potential to improve language abilities, particularly in those with more severe language deficits at baseline.

The study's results suggest that tDCS can enhance global language performance and specific language skills, indicating that the severity of language impairment may help predict which patients will benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia. McConathey, EM., White, NC., Gervits, F., et al.[2022]

In a study of 39 participants with primary progressive aphasia (PPA), both transcranial direct current stimulation (tDCS) and sham treatment improved language therapy outcomes, with tDCS showing greater benefits, especially for untrained words.

The integrity of white matter pathways in the brain was found to predict the effectiveness of tDCS in enhancing language therapy, suggesting that assessing white matter integrity could help identify patients who are more likely to benefit from these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

White Matter Integrity Predicts Electrical Stimulation (tDCS) and Language Therapy Effects in Primary Progressive Aphasia. Zhao, Y., Ficek, B., Webster, K., et al.[2021]

Transcranial direct current stimulation (tDCS) combined with a spelling intervention showed promise in improving written language functions in six participants with primary progressive aphasia (PPA), particularly for untrained items, indicating a potential for broader language therapy benefits.

The improvements in language function were more sustained with tDCS compared to sham treatment, suggesting that neuromodulation could enhance the effectiveness of language therapy in PPA, although the small sample size necessitates cautious interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges. Tsapkini, K., Frangakis, C., Gomez, Y., et al.[2022]

Speech-language interventions can significantly improve language outcomes for individuals with primary progressive aphasia (PPA), particularly in the short term.

Transcranial direct current stimulation (tDCS) combined with written production intervention enhances the generalization and maintenance of these positive language outcomes, suggesting a promising treatment approach for PPA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Primary Progressive Aphasia. Tippett, DC., Hillis, AE., Tsapkini, K.[2022]

Language training, whether alone or combined with transcranial direct current stimulation (tDCS), significantly improves oral naming accuracy in patients with Primary Progressive Aphasia (PPA), with gains maintained over time.

The combination of language training and tDCS not only enhances oral naming for trained items but also improves accuracy for untrained items, and it boosts written naming abilities for both trained and untrained items immediately after training and at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of language training and non-invasive brain stimulation on oral and written naming performance in Primary Progressive Aphasia: A meta-analysis and systematic review. Cotelli, M., Manenti, R., Ferrari, C., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8530184/

A Systematic Review of Transcranial Direct Current ... Studies of tDCS in PPA included a total of 52 SvPPA, 62 LvPPA, 102 NFvPPA, and 8 NFvPPA/apraxia of speech patients. Most studies included a mixed group of PPA.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352873718300441

Electrical brain stimulation in different variants of primary ... Transcranial direct current stimulation (tDCS) has been recently shown to improve language outcomes in primary progressive aphasia (PPA) but most studies ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05386394

NCT05386394 | Transcranial Direct Current Stimulation in ... Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges.

4. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000210383

A Systematic Review and Updated Meta-analysis (P8-3.012) Our findings suggest that tDCS may be efficacious in augmenting naming tasks both acutely and over a prolonged period of up to two months.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1543712/full

Feasibility of home-based transcranial direct current ... These studies have reported the treatment to be safe and well-tolerated, and to improve language outcomes compared to SLT alone (24–28).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384709/

Efficacy of Transcranial Magnetic Stimulation and ... Both rTMS and tDCS are generally safe and may result in meaningful improvements in language abilities [75,77]. However, findings in PPA remain ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213158218301682

The effect of tDCS on functional connectivity in primary ... The present study tested whether the additional language gains with repetitive tDCS (over sham) in PPA are caused by changes in functional connectivity.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837379

Long-Term Therapy With Transcranial Magnetic ... This randomized clinical trial assesses whether long-term transcranial magnetic stimulation (TMS) combined with language therapy is ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11852435/

Feasibility of home-based transcranial direct current ... Our case series demonstrates that home-based tDCS added to SLT is feasible for patients with PPA. However, larger controlled studies are required to confirm ...