HD-tDCS + Speech Therapy for Aphasia

Overseen By Sara Pillay, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Advanced neurodegenerative, Neurologic, Severe psychopathology, others

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

Compensation: Varies

Number of Visits: 20

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how gentle electrical stimulation (targeted transcranial direct current stimulation), combined with speech therapy, aids in recovering language skills after a stroke. Participants will be divided into groups to receive either real or sham electrical stimulation, along with one of two types of speech therapy. The trial targets individuals who have experienced a stroke or similar event affecting language abilities and can speak English. Participants must be comfortable with MRIs and free from certain health conditions, such as severe mental health issues or advanced neurodegenerative diseases. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

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's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that transcranial direct-current stimulation (tDCS) combined with speech therapy can aid in regaining language skills after a stroke. Studies have found tDCS to be safe, noninvasive, and painless, causing no harm or discomfort during use.

In earlier studies, both regular and high-definition tDCS (HD-tDCS) were well-received. Participants improved in naming objects and answering questions more quickly, indicating that side effects are minor and the treatment is manageable.

Overall, previous research suggests that using HD-tDCS with speech therapy is safe for individuals with language difficulties after a stroke. This combination may enhance speech recovery without causing significant discomfort or harm. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the combination of HD-tDCS and specialized speech therapy to treat aphasia in a novel way. Unlike traditional speech therapy, which focuses solely on language exercises, HD-tDCS (high-definition transcranial direct current stimulation) uses electrical stimulation to potentially enhance brain plasticity and recovery. This dual approach might offer a more effective rehabilitation by directly targeting brain function while simultaneously engaging language skills. The possibility of synergistic effects between the electrical stimulation and targeted speech therapy is what has researchers intrigued about its potential benefits for those with aphasia.

What evidence suggests that this trial's treatments could be effective for aphasia?

Research has shown that high-definition transcranial direct current stimulation (HD-tDCS) combined with speech therapy can aid in recovering language skills after a stroke. In this trial, participants will be randomized to receive either anodal HD-tDCS or sham-tDCS. Studies have found that HD-tDCS, when paired with speech therapy, enables people to name objects more accurately and quickly than speech therapy alone. This gentle electrical stimulation can enhance naming accuracy and response speed.

Another group in this trial will receive speech therapy, which is also highly effective. Real-world evidence indicates that intensive speech therapy can significantly improve language comprehension and speaking skills. Many patients experience positive changes, especially with 20 to 50 hours of therapy. These findings suggest that both HD-tDCS and speech therapy can aid language recovery after a stroke. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with aphasia from left-sided brain damage like a stroke, who can speak English and are MRI-eligible. It's not for those with advanced neurodegenerative diseases, unmanaged seizure disorders, severe mental health issues, major hearing or vision problems, developmental disabilities, or MRI contraindications such as metal implants.

Inclusion Criteria

My eligibility is not affected by my race, ethnicity, or gender.

I am an adult who speaks and understands English fluently.

You are able to have an MRI scan.

Exclusion Criteria

I have hearing, vision difficulties, or a learning disability that cannot be corrected.

I cannot have an MRI due to claustrophobia, implants, metal in my body, obesity, pregnancy, or inability to lie flat or see/hear well.

I have a neurological condition like epilepsy, Parkinson's, or ALS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle A

Participants receive targeted anodal-tDCS or sham-tDCS along with speech therapy for 10 sessions

2 weeks

10 visits (in-person)

Assessment and Crossover

Participants undergo behavioral assessment and fMRI before crossing over to receive the alternate tDCS intervention

1-2 weeks

Treatment Cycle B

Participants receive the alternate tDCS intervention along with the same speech therapy arm for another 10 sessions

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with behavioral assessments and fMRI at 3 and 6 months post Treatment Cycle B

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Speech Therapy
• Targeted Transcranial Direct Current Stimulation

Trial Overview The study tests if mild electrical stimulation to the brain (HD-tDCS) combined with speech therapy helps language recovery in people who have speech difficulties after a stroke. Participants will receive this combination treatment and their progress will be monitored.

How Is the Trial Designed?

Group I: Speech Therapy Experimental Treatment 1 Intervention

Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy

Group II: HD-tDCS Experimental Treatment 1 Intervention

Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) is a promising non-invasive technique that can enhance the effectiveness of speech therapy for individuals with aphasia, as indicated by a review of 35 studies published over the last decade.

Combining tDCS with online speech therapy interventions is more beneficial than offline methods, suggesting that real-time application of tDCS during therapy can lead to better improvements in language deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation and speech therapy intervention in people with aphasia: a systematic review of the literature]. Corrales-Quispiricra, C., Gadea, ME., Espert, R.[2021]

Transcranial direct current stimulation (tDCS) combined with language training showed improved verb production in a 43-year-old male with fluent-anomic aphasia after a stroke, suggesting enhanced language recovery.

The study indicates that using tDCS over Broca's area during language therapy may effectively support brain plasticity and improve language skills in individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational treatment of aphasia combining neuromodulation and behavioral intervention for lexical retrieval: implications from a single case study. Galletta, EE., Vogel-Eyny, A.[2020]

Transcranial direct current stimulation (tDCS) combined with speech and language treatment (SLT) is safe for stroke survivors with aphasia, showing no serious adverse events during a six-week treatment involving 30 sessions.

Participants receiving active tDCS exhibited greater improvements in functional language compared to those receiving sham treatment, suggesting that tDCS may enhance the effectiveness of SLT, although the superiority of one stimulation polarity over another remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial. Cherney, LR., Babbitt, EM., Wang, X., et al.[2021]

In a study involving 11 chronic stroke patients with aphasia, dual transcranial direct current stimulation (tDCS) showed a significant improvement in naming response times compared to baseline, suggesting enhanced efficacy over single tDCS.

Both single and dual tDCS improved the number of correct responses in naming tasks, but dual tDCS, which targeted both the left and right inferior frontal gyri, may offer greater benefits for language recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dual transcranial direct current stimulation for aphasia in chronic stroke patients. Lee, SY., Cheon, HJ., Yoon, KJ., et al.[2021]

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 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]

In a pilot study involving 10 patients with post-stroke aphasia, those who received anodal transcranial Direct Current Stimulation (atDCS) alongside behavioral naming training showed significantly better improvements in naming abilities compared to those who received sham stimulation.

Both groups improved in overall language skills, but the targeted atDCS treatment specifically enhanced outcomes in the Naming category, suggesting that atDCS may effectively augment traditional therapy for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined anodal transcranial direct current stimulation and behavioural naming treatment improves language performance in patients with post-stroke aphasia. Cid-Fernández, S., Rivas-Fernández, MÁ., Varela-López, B., 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]

In a study of 37 stroke patients, speech therapy combined with transcranial direct current stimulation (tDCS) significantly improved language function, with an average increase in aphasia quotient (AQ%) of 14.94% after treatment.

Patients with less severe, fluent types of aphasia who started treatment within 30 days of their stroke showed the best responses, and those with hemorrhagic strokes had a higher likelihood of improvement compared to those with infarctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Factors Associated with Good Responses to Speech Therapy Combined with Transcranial Direct Current Stimulation in Post-stroke Aphasic Patients. Jung, IY., Lim, JY., Kang, EK., et al.[2021]

Transcranial direct current stimulation (tDCS) has shown promising results in enhancing language rehabilitation for patients with aphasia, a common language disorder following a stroke.

Traditional language therapies often leave patients with chronic deficits, highlighting the urgent need for innovative treatments like tDCS to improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential effects of transcranial direct current stimulation (tDCS) on language functioning: Combining neuromodulation and behavioral intervention in aphasia. Marangolo, P.[2021]

A systematic review of 25 studies involving 471 participants found that Transcranial Direct Current Stimulation (tDCS) did not improve overall functional communication in stroke patients, indicating limited efficacy for this primary outcome.

However, anodal tDCS, especially when applied over the left inferior frontal gyrus, showed a significant improvement in noun naming performance, suggesting it may be a promising targeted treatment for specific language deficits after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia after stroke: a systematic review with network meta-analysis of randomized controlled trials. Elsner, B., Kugler, J., Mehrholz, J.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000885

Effect of transcranial direct current stimulation combined ... tDCS combined with SLT demonstrates potential enhancement in language recovery on post-ischemic stroke aphasia. The combination may augment speech content, ...

2. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-23-00312

Effectiveness of Transcranial Direct Current Stimulation as ... The weight of the evidence suggests that tDCS paired with SLT improves noun-naming outcomes in chronic aphasia beyond the effects of SLT alone.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25547776/

Feasibility of using high-definition transcranial direct ... - PubMed CS-tDCS and HD-tDCS were comparable in terms of implementation, acceptability, and outcomes. Naming accuracy and response time improved for both stimulation ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04166513

Effects of Transcranial Direct Current Stimulation (tDCS) on ... This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance ...

5. 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] ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8722401/

Transcranial Direct-Current Stimulation and Behavioral ... tDCS has led to promising results in rehabilitating patients with acquired aphasia, especially if combined with different language and communication therapies.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5764169/

Feasibility of using high-definition transcranial direct current ... CS-tDCS and HD-tDCS were comparable in terms of implementation, acceptability, and outcomes. Naming accuracy and response time improved for both stimulation ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.041557

Transcranial Direct-Current Stimulation in Subacute Aphasia Transcranial direct-current stimulation (tDCS) is a promising adjunct to traditional language therapy. tDCS is a safe, noninvasive, nonpainful ...