tDCS + Language Therapy for Primary Progressive Aphasia

Recruiting at 2 trial locations

Overseen By Kyrana Tsapkini, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive impairment, Neurological conditions, Pacemakers, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

While many have strongly suggested that transcranial direct current stimulation (tDCS) may represent a beneficial intervention for patients with primary progressive aphasia (PPA), this promising technology has not yet been applied widely in clinical settings. This treatment gap is underscored by the absence of any neurally-focused standard-of-care treatments to mitigate the devastating impact of aphasia on patients' family, work, and social lives. Given that tDCS is inexpensive, easy to use (it is potentially amenable to home use by patients and caregivers), minimally invasive, and safe there is great promise to advance this intervention toward clinical use. The principal reason that tDCS has not found wide clinical application yet is that its efficacy has not been tested in large, multi-center, clinical trials. In this study, scientists in the three sites that have conducted tDCS clinical trials in North America-Johns Hopkins University and the University of Pennsylvania in the US, and the University of Toronto in Canada, will collaborate to conduct a multi-site, Phase II clinical trial of tDCS a population in dire need of better treatments.

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.

What data supports the effectiveness of the treatment tDCS + Language Therapy for Primary Progressive Aphasia?

Research shows that combining transcranial direct current stimulation (tDCS) with language therapy can improve language skills in people with Primary Progressive Aphasia, especially in naming tasks. This combination helps maintain language improvements over time and can even enhance performance on tasks that were not specifically trained during therapy. ^{1 2 3 4 5}

Is tDCS safe for use in humans?

Transcranial direct current stimulation (tDCS) is considered safe, portable, and noninvasive, and it has been used in various studies to enhance language therapy outcomes in people with aphasia. ^{1 4 6 7 8}

How does the tDCS + Language Therapy treatment differ from other treatments for primary progressive aphasia?

The tDCS + Language Therapy treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate specific brain areas, with language therapy to enhance language abilities in primary progressive aphasia. This approach is novel as it targets brain excitability and language function simultaneously, potentially offering benefits beyond traditional language therapy alone. ^{1 2 4 8 9}

Research Team

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Active tDCS + Language Therapy (Device)
• Sham tDCS + Language Therapy (Device)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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) 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in post stroke aphasia and primary progressive aphasia: Current knowledge and future clinical applications. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

White Matter Integrity Predicts Electrical Stimulation (tDCS) and Language Therapy Effects in Primary Progressive Aphasia. [2021]

3. United States 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Can tDCS enhance treatment of aphasia after stroke? [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of Transcranial Direct Current Stimulation in Primary Progressive Aphasia: Methodological Considerations. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Anodic Transcranial Direct Current Stimulation Combined With Speech Language Therapy on Nonfluent Poststroke Aphasia. [2022]

8. New Zealand 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. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia. [2022]