tDCS + Language Therapy for Primary Progressive Aphasia

(PPA Trial)

Overseen By Aneta Kielar, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Disqualifiers: Epilepsy, Parkinson's, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a gentle electrical current applied to the scalp to help patients with Primary Progressive Aphasia improve their language abilities. The treatment stimulates specific brain areas, helping the brain reorganize around damaged regions. This method has shown promise in improving language symptoms in patients with primary progressive aphasia and post-stroke aphasia.

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 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 abilities in people with primary progressive aphasia (PPA). Studies indicate that this combination helps with oral and written naming tasks, and the improvements can last over time, even for untrained items. ^{1 2 3 4 5}

Is tDCS combined with language therapy safe for humans?

Transcranial direct current stimulation (tDCS) has been studied in various conditions, including primary progressive aphasia and post-stroke aphasia, and is generally considered safe when used as directed in clinical settings. It involves applying a small electrical current to the brain, and while it may cause mild side effects like tingling or skin irritation, serious adverse effects are rare. ^{1 2 4 6 7}

How does the treatment of tDCS combined with Language Therapy differ from other treatments for Primary Progressive Aphasia?

The combination of transcranial direct current stimulation (tDCS) with Language Therapy is unique because it uses electrical stimulation to enhance the brain's language areas, potentially improving language outcomes in Primary Progressive Aphasia. This approach is different from standard treatments as it directly targets brain activity to support language therapy, which may slow down language decline or improve language abilities. ^{1 2 6 7 8}

Research Team

Aneta Kielar, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Language Therapy (Behavioural Intervention)
• tDCS (Procedure)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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) 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]

References

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

Transcranial direct current stimulation for the treatment of primary progressive aphasia: An open-label pilot study. [2022]

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. England pubmed.ncbi.nlm.nih.gov

Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges. [2022]

4. 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]

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

Treatment of Primary Progressive Aphasia. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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