tACS for Aphasia After Stroke

Overseen By Priyanka Shah-Basak, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Severe cognitive impairments, Unstable psychiatric disease, Cardiac stimulators, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke.

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 HD-tACS for aphasia after stroke?

Research on a similar treatment, transcranial direct current stimulation (tDCS), suggests it can help improve language skills in stroke patients with aphasia when combined with speech therapy. This non-invasive brain stimulation may enhance brain plasticity, which is the brain's ability to adapt and change, potentially leading to better recovery of language abilities. ^{1 2 3 4 5}

How is the treatment HD-tACS for aphasia after stroke different from other treatments?

HD-tACS (High-Definition Transcranial Alternating Current Stimulation) is a unique treatment for aphasia after stroke because it uses a non-invasive method to deliver electrical currents to the brain, potentially enhancing the effects of speech and language therapy. Unlike traditional treatments, it specifically targets brain activity patterns with alternating currents, which may offer a novel way to improve language recovery. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for English-speaking adults over 18 who have had a stroke affecting the left side of their brain, leading to aphasia. They must be at least one month post-stroke. People with severe sensory impairments, untreated psychiatric diseases, unstable medical conditions, pacemakers or cardiac stimulators, seizure disorders, dyslexia or learning disabilities cannot participate.

Inclusion Criteria

I had a stroke that affected the left side of my brain.

Fluent in English

Consent date >= 1 month after stroke onset

Exclusion Criteria

I have a chronic condition that is not being treated or is unstable.

The presence of cardiac stimulators or pacemakers

I have seizures that are not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-definition tACS combined with short-term memory focused speech therapy

2 weeks

10 intervention days

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Treatment Details

Interventions

• HD-tACS
• Sham HD-tACS

Trial Overview The study is testing whether transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique, can help improve short-term memory for words in people who have language difficulties after a stroke. Some participants will receive real tACS while others get sham (fake) treatment as a comparison.

Participant Groups

Group I: High Definition tACS with Short-term Memory Focused Speech Therapy Experimental Treatment 1 Intervention

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages.The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS stimulation for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes. This will be paired with short-term memory focused speech therapy.

Group II: Sham-High Definition tACS with Short-term Memory Focused Speech Therapy Placebo Group 1 Intervention

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups. This will be paired with short-term memory focused speech therapy.

HD-tACS is already approved in United States, European Union for the following indications:

Approved in United States as HD-tACS for:

• Research use for conditions such as aphasia after stroke
• Fibromyalgia (research use)

Approved in European Union as HD-tACS for:

• Research use for neurological conditions
• Memory enhancement in older adults (research use)

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

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]

A systematic review of five trials with 54 participants found no evidence that transcranial direct current stimulation (tDCS) improves speech and language therapy outcomes for stroke patients with aphasia.

While no adverse events were reported, the studies primarily measured picture naming rather than real-life communication, and cathodal tDCS over the non-lesioned hemisphere showed potential as a promising approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia in patients after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2022]

A systematic review of 21 trials involving 421 participants found no evidence that transcranial direct current stimulation (tDCS) improves functional communication in people with aphasia after stroke, indicating low effectiveness for this purpose.

However, there is moderate evidence that tDCS may enhance noun naming accuracy, suggesting it could have some benefits in specific language tasks, although it did not show similar effects for verb naming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia in adults with aphasia after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2023]

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]

A systematic review of 12 trials involving 136 participants found no evidence that transcranial direct current stimulation (tDCS) improves functional communication or language impairment in stroke patients with aphasia.

The meta-analysis of six trials indicated that tDCS did not significantly enhance outcomes in picture naming tasks, suggesting that it may not be an effective adjunct to speech and language therapy for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Elsner, B., Kugler, J., Pohl, M., 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]

References

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

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

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

Transcranial direct current stimulation (tDCS) for improving aphasia in patients after stroke. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia in adults with aphasia after stroke. [2023]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. [2022]