tDCS + Speech-Language Therapy for Aphasia

(AphasiatDCS Trial)

Overseen By Honey Hubbard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 3 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist people with aphasia (difficulty with speech and language) after a stroke. It combines a technique called tDCS (Transcranial Direct Current Stimulation), which gently stimulates the brain electrically, with speech-language therapy. Participants will receive either the actual tDCS treatment or a placebo version, alongside the therapy sessions. It suits those who had a stroke over a year ago and continue to experience speech difficulties. The goal is to determine if this combined treatment can enhance speech and language skills. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for improving these skills.

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 prior data suggests that this tDCS + Speech-Language Therapy is safe for treating aphasia?

Research shows that transcranial Direct Current Stimulation (tDCS) is generally safe for people recovering from strokes. tDCS is a noninvasive and painless method that uses a small electrical current to stimulate the brain. People with aphasia, a condition affecting speaking and understanding language, have used tDCS in their recovery without major problems.

Studies report that tDCS is well-tolerated. The most common side effects are mild and temporary, such as a tingling sensation or slight skin irritation where the stimulation is applied. These effects usually disappear quickly. One study found that using tDCS along with speech therapy is effective and safe in the early stages of aphasia recovery.

For those considering joining a trial involving tDCS, research suggests the treatment is safe with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of targeted transcranial direct current stimulation (tDCS) for treating aphasia because it offers a non-invasive approach that may enhance brain plasticity and recovery post-stroke. Unlike traditional speech-language therapy alone, which primarily relies on repetitive practice to improve language skills, tDCS involves a gentle electrical current that can stimulate specific brain areas, potentially speeding up the recovery process. This combination of tDCS with speech-language training could lead to more effective and quicker improvements in language function, making it a promising option for those affected by stroke-induced aphasia.

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

Research shows that a gentle electrical brain stimulation technique called transcranial direct current stimulation (tDCS), combined with speech-language therapy (SLT), might help people with aphasia recover language skills after a stroke. In this trial, participants will be divided into two groups: one will receive active cathodal tDCS with speech-language training, while the other will receive placebo cathodal tDCS with speech-language training. Studies have found that tDCS can improve speech content and the ability to name objects. Some reviews and analyses also suggest it may help with general language skills, such as repeating words and speaking smoothly. However, results are mixed, and not all studies have found tDCS more effective than other treatments. The potential for tDCS to aid language recovery continues to be actively explored. ^{2 3 6 7 8}

Who Is on the Research Team?

Jessica Richardson, Ph.D.

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Targeted 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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) 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]

Citations

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Effectiveness of Transcranial Direct Current Stimulation as ...

All SRs and one MA reported improvements following tDCS stimulation for general aphasia abilities and measures of repetition and speech fluency.

4.

pubmed.ncbi.nlm.nih.gov

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Evidence From Systematic Reviews and Meta-Analyses

All SRs and one MA reported improvements following tDCS stimulation for general aphasia abilities and measures of repetition and speech fluency.

5.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.122.041557

Transcranial Direct-Current Stimulation in Subacute Aphasia

This single-center, randomized, double-blind, sham-controlled efficacy trial tested the hypothesis that anodal tDCS augments language therapy in subacute ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ...

This review analyzes the reported adverse effects in stroke, looking for factors that may induce side-effects.

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frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.01089/full

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In summary, preliminary data suggest that anodal-tDCS can benefit naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT01486654?term=AREA%5BBasicSearch%5D(aphasia)%20AND%20AREA%5BSponsorSearch%5D(NIDCD)&rank=6

Transcranial Direct Current Stimulation and Aphasia ...

This study proposes to evaluate the safety, feasibility, and effectiveness of anodal and cathodal tDCS in study subjects with Broca's aphasia after stroke, ...