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

Trial Summary

What is the purpose of this trial?

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

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.

What data supports the effectiveness of the treatment HD-tDCS + Speech Therapy for Aphasia?

Research shows that combining transcranial direct current stimulation (tDCS) with speech therapy can help improve language skills in people with aphasia after a stroke. Studies have found that this combination can lead to better language comprehension and production, offering promising results for recovery. ^{1 2 3 4 5}

Is the combination of transcranial direct current stimulation (tDCS) and speech therapy safe for humans?

Research shows that transcranial direct current stimulation (tDCS) combined with speech therapy is generally safe for humans, with no serious adverse events reported in studies involving people with aphasia after stroke. ^{6 7 8 9 10}

How does the HD-tDCS + Speech Therapy treatment for aphasia differ from other treatments?

The HD-tDCS + Speech Therapy treatment is unique because it combines transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, with traditional speech therapy to enhance brain plasticity and improve language recovery in aphasia patients. This approach aims to boost the effectiveness of speech therapy by facilitating brain activity, offering a novel strategy compared to standard speech therapies alone. ^{1 3 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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 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) 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]

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]

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) 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]

References

1. Korea (South) 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. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of dual transcranial direct current stimulation for aphasia in chronic stroke patients. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Combined anodal transcranial direct current stimulation and behavioural naming treatment improves language performance in patients with post-stroke aphasia. [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. Switzerland 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. [2021]

8. England 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. [2020]

9. Spain pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation and speech therapy intervention in people with aphasia: a systematic review of the literature]. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Translational treatment of aphasia combining neuromodulation and behavioral intervention for lexical retrieval: implications from a single case study. [2020]

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

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