tDCS + Language Therapy for Primary Progressive Aphasia

Recruiting at 2 trial locations

Overseen By Kyrana Tsapkini, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive impairment, Neurological conditions, Pacemakers, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 33

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with primary progressive aphasia (PPA), a condition that affects language skills. The treatment combines language therapy with transcranial direct current stimulation (tDCS), a non-invasive, safe, and potentially home-friendly method that uses mild electrical currents to stimulate the brain. The study aims to determine if this approach can improve communication for those with PPA. It seeks participants who have PPA and can understand the study details and consent to join. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in PPA treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently abusing alcohol or drugs, or participating in another trial, you may be excluded from this study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In various studies, patients who received tDCS reported only minor side effects, such as mild tingling or itching at the application site. One study focused on individuals with primary progressive aphasia (PPA) and found that participants tolerated tDCS well, with no serious adverse effects reported. This suggests that tDCS could be a safe option for people with PPA considering clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for aphasia?

Researchers are excited about the combination of transcranial direct current stimulation (tDCS) and language therapy for treating Primary Progressive Aphasia (PPA) because it offers a unique approach compared to current standard treatments like speech and language therapy alone. Unlike traditional methods, tDCS applies a gentle electrical current to the brain, potentially enhancing the effectiveness of language therapy by boosting brain plasticity and connectivity. This dual approach aims to improve language skills more effectively and efficiently, offering new hope for individuals with PPA who have limited options for significant improvement.

What evidence suggests that tDCS + Language Therapy might be an effective treatment for primary progressive aphasia?

This trial will compare two approaches: Active tDCS combined with language therapy and Sham tDCS combined with language therapy. Studies have shown that transcranial direct current stimulation (tDCS) can improve language skills in people with primary progressive aphasia (PPA). Research suggests that tDCS may enhance performance in naming tasks immediately and sustain improvement for up to two months. Early findings indicate that combining tDCS with language therapy might enhance the therapy's effectiveness. This treatment is gaining attention for its safety, ease of use, and potential affordability. While more large-scale studies are needed, early results are promising for those dealing with PPA. ^{2 6 7 8 9}

Who Is on the Research Team?

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 with non-fluent or logopenic primary progressive aphasia (PPA), who have at least a high school education and can consent to the study. Excluded are those with recent participation in other trials, left-handedness, pregnancy, severe cardiopulmonary disorders, pacemakers, terminal illness, major psychiatric issues that affect study compliance, previous skull breaches, certain MRI exclusions like claustrophobia or metal implants near the eye.

Inclusion Criteria

I am between 50 and 80 years old.

High school education (or more)

I have speech difficulties due to specific brain conditions.

Exclusion Criteria

You have metal objects in your face or head, except for dental braces, fillings, or implants.

You have an illness that is expected to make you very sick and may not live for much longer than a year.

I haven't had unexplained fainting or complex seizures in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive Naming and Spelling (NASP) treatment with either active tDCS or sham condition for 3 weeks, with 5 language therapy sessions per week.

3 weeks

15 sessions (in-person)

Wash-out

A 3-month stimulation-free period to evaluate clinically meaningful effects.

3 months

Treatment Period 2

Participants receive the alternate condition (active tDCS or sham) for another 3 weeks, with 5 language therapy sessions per week.

3 weeks

15 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging and cognitive assessments.

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS + Language Therapy
• Sham tDCS + Language Therapy

Trial Overview

The trial tests transcranial direct current stimulation (tDCS) combined with language therapy against a sham tDCS plus language therapy to see if it helps PPA patients. It's a Phase II multi-center clinical trial conducted by Johns Hopkins University, University of Pennsylvania and University of Toronto.

How Is the Trial Designed?

Group I: Active tDCS + Language Therapy first Experimental Treatment 2 Interventions

Active tDCS will be applied at the beginning of 45 minutes language therapy session and will last for 20 minutes.

Group II: Sham tDCS + Language Therapy first Placebo Group 2 Interventions

Sham tDCS will be applied at the beginning of 45 minutes language therapy session.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) applied to the left inferior frontal gyrus significantly improved language abilities in patients with nonfluent poststroke aphasia when combined with speech language therapy, as shown by a higher Aphasia Quotient in the A-tDCS group compared to the sham group (72.99 vs. 46.18).

The study involved 18 patients over four weeks, with results indicating that tDCS enhances the effectiveness of speech language therapy, particularly in areas other than comprehension, suggesting a beneficial mechanism of action for language recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Anodic Transcranial Direct Current Stimulation Combined With Speech Language Therapy on Nonfluent Poststroke Aphasia. Zhao, Q., Wang, J., Li, Z., et al.[2022]

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]

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]

In a study involving 10 individuals undergoing standard aphasia therapy, 70% expressed interest in and were eligible for transcranial direct current stimulation (tDCS), which was administered during therapy sessions.

Data from four participants showed a large effect size (Cohen's d = 1.32) favoring active tDCS over sham stimulation, suggesting that tDCS may enhance communication outcomes in aphasia therapy, although one participant with severe deficits did not benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. Duncan, ES., Nakkawita, SG.[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]

Transcranial direct-current stimulation (tDCS) significantly improved articulatory accuracy in patients with aphasia after stroke, indicating its potential effectiveness in enhancing speech production.

While tDCS showed qualitative improvements in naming and syllable repetition tasks, these results were not statistically significant, suggesting that further research is needed to fully understand its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial. Vila-Nova, C., Lucena, PH., Lucena, R., et al.[2021]

Transcranial direct current stimulation (tDCS) shows promise as an adjuvant treatment for improving speech production in chronic stroke patients with aphasia, based on preliminary evidence.

Further research is needed to fully understand how tDCS works, its optimal application in language rehabilitation, and how it interacts with existing therapies to enhance long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can tDCS enhance treatment of aphasia after stroke? Holland, R., Crinion, J.[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) 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]

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/S0149763425002659

Linguistic effects of transcranial Direct Current Stimulation ...

Transcranial Direct Current Stimulation (tDCS) has shown promising language improvements in patients with primary progressive aphasia (PPA).

3.

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.

4.

pmc.ncbi.nlm.nih.gov

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

Efficacy of Transcranial Magnetic Stimulation and ...

Evidence suggests that rTMS can improve naming, repetition, writing, and comprehension abilities in post-stroke aphasia patients [84,85,86,87,88] ...

5.

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.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05386394

Transcranial Direct Current Stimulation in the Treatment of ...

Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges.

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2837379

Long-Term Therapy With Transcranial Magnetic ...

We conducted a prospective, double-blind, parallel-design randomized clinical trial (Long-Term Effect of TMS in Primary Progressive Aphasia [ ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06473714

Effects of Transcranial Direct Current Stimulation (tDCS) on ...

This project will provide new insights into the nature of the neural activity underlying executive functions in people with primary progressive aphasia ...

9.

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 ...