tDCS + Speech-Language Therapy for Aphasia

(AphasiatDCS Trial)

Overseen by Jessica Richardson, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of New Mexico

Disqualifiers: Neurological disease, Mood disorder, Substance abuse, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a non-invasive brain stimulation technique combined with speech therapy to help stroke patients with Aphasia improve their communication skills. The brain stimulation aims to enhance the effects of language therapy by making the brain's language areas work better together. This technique has shown promise in improving language recovery in 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.

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

Research shows that combining transcranial direct current stimulation (tDCS) with speech-language therapy can improve language abilities in stroke survivors with aphasia. Studies found that active tDCS led to greater language gains compared to a placebo, and cathodal tDCS significantly improved naming accuracy in patients. ^{1 2 3 4 5}

Is tDCS safe for use in humans, particularly for those with aphasia?

Research shows that tDCS, when combined with speech-language therapy, is generally safe for people with aphasia, as no serious side effects were reported during a study involving 30 treatment sessions over six weeks. ^{4 5 6 7 8}

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

This treatment combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with speech-language therapy to enhance language recovery in stroke survivors with aphasia. Unlike standard speech therapy alone, this approach may lead to greater improvements in language function by targeting specific brain areas and increasing cortical activity. ^{1 3 4 5 9}

Research Team

Jessica Richardson, Ph.D.

Principal Investigator

University of New Mexico

Eligibility Criteria

This trial is for individuals aged 25-85 who are more than a year post-stroke and have aphasia, which affects their language abilities. They must show left-hemisphere brain damage and be responsive to naming tasks. People with other neurological diseases, right hemisphere damage, mood disorders, recent substance abuse, electrical implants that interfere with tDCS or MRI scans, medical instability or pregnancy cannot participate.

Inclusion Criteria

It has been over a year since I had a stroke.

I am between 25 and 85 years old.

You must have difficulty speaking and understanding language due to damage on the left side of your brain.

Exclusion Criteria

I have not had any serious health changes in the last 4 weeks.

I have a neurological condition.

You have struggled with drug or alcohol problems in the last year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 15 sessions of tDCS combined with speech-language training on consecutive weekdays

3 weeks

15 visits (in-person)

Assessment

Participants have 4 assessment sessions: 2 pretreatment, 1 immediately post-treatment, and 1 at 3 months follow-up

3 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Targeted TDCS (Transcranial Direct Current Stimulation (tDCS))

Trial Overview The study tests if targeted Transcranial Direct Current Stimulation (tDCS) can improve speech-language therapy outcomes in people with chronic aphasia after a stroke. Participants will receive either active cathodal tDCS or placebo alongside language training for 15 days to see which is more effective.

Participant Groups

Group I: Experimental: Active cathodal tDCS + Speech-language training Active Control 1 Intervention

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.

Group II: Comparator: Placebo cathodal tDCS + Speech-language training Placebo Group 1 Intervention

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

This study demonstrated that transcranial direct current stimulation (tDCS) can be precisely targeted to an individualized brain area in post-stroke aphasia patients, showing increased neural activity in the left inferior frontal gyrus during stimulation.

The successful application of tDCS alongside functional MRI suggests that this method can help uncover the neural mechanisms behind tDCS effects, paving the way for future research to explore how tDCS can improve language processing in larger groups of aphasia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Mechanisms Underlying Perilesional Transcranial Direct Current Stimulation in Aphasia: A Feasibility Study. Ulm, L., McMahon, K., Copland, D., et al.[2020]

In a study involving eight chronic non-fluent post-stroke aphasic patients, cathodal transcranial direct current stimulation (tDCS) significantly improved picture naming accuracy by an average of 33.6%.

Anodal and sham tDCS did not produce any noticeable changes in performance, suggesting that cathodal tDCS may be a promising technique for enhancing language recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved naming after transcranial direct current stimulation in aphasia. Monti, A., Cogiamanian, F., Marceglia, S., 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) 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]

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]

In a study of 58 right-handed English speakers with subacute aphasia, transcranial direct-current stimulation (tDCS) did not significantly enhance picture naming accuracy compared to sham treatment, indicating limited efficacy for this specific outcome.

However, tDCS was associated with greater improvements in discourse skills, which are important for communication, and no adverse events were reported, suggesting it is a safe adjunct to language therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. Stockbridge, MD., Elm, J., Breining, BL., et al.[2023]

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 of 14 individuals with post-stroke aphasia, transcranial direct current stimulation (tDCS) showed significant improvement in naming tasks, particularly in the Boston test, indicating its potential efficacy in language rehabilitation.

The study suggests that the placement of electrodes over specific brain areas can enhance recovery in patients with anomic and Broca's aphasia, highlighting the importance of considering language strategies in treatment assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: a study on naming performance in aphasic individuals. Silva, FRD., Mac-Kay, APMG., Chao, JC., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Neural Mechanisms Underlying Perilesional Transcranial Direct Current Stimulation in Aphasia: A Feasibility Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Improved naming after transcranial direct current stimulation in aphasia. [2022]

3. 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]

4. 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]

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

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

6. 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]

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

Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. [2023]

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. Brazil pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: a study on naming performance in aphasic individuals. [2022]