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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help stroke survivors improve language skills. It uses transcranial alternating current stimulation (tACS), which sends mild electrical currents to the brain, combined with speech therapy focused on short-term memory. The trial compares two groups: one receives active HD-tACS treatment, and the other receives a sham (placebo-like) treatment. It is ideal for those who have experienced a stroke affecting the left side of the brain and are facing language problems (aphasia). Participants should be fluent in English and have had their stroke at least one month ago. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance recovery and improve the quality of life 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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that HD-tACS is safe for language recovery after stroke?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe. Studies have found that tACS can aid stroke recovery without causing serious side effects. Participants often feel mild sensations, like tingling, during treatment. This suggests that tACS is safe for most people, with only minor discomfort reported.

Researchers are studying the treatment's potential to help stroke patients regain language skills. So far, studies have not identified any major safety concerns, making it a promising option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for aphasia after a stroke involve speech therapy and medications to improve blood flow to the brain. However, high-definition transcranial alternating current stimulation (HD-tACS) is unique because it directly targets brain activity with electrical stimulation, potentially enhancing brain plasticity and recovery. Researchers are excited about HD-tACS because it offers a non-invasive way to boost the effects of traditional speech therapy by applying mild electrical currents to the brain, which could accelerate recovery. Additionally, pairing HD-tACS with short-term memory-focused speech therapy might provide a more comprehensive approach, potentially improving both memory and language skills simultaneously.

What evidence suggests that HD-tACS is effective for language recovery after stroke?

Research has shown that transcranial alternating current stimulation (tACS) can aid in language recovery after a stroke. One study found that tACS helped stroke patients improve their overall recovery. Another study indicated that tACS might enhance speech for people with nonfluent aphasia, a condition where speaking is challenging. In this trial, participants will receive either HD-tACS or Sham HD-tACS, both paired with short-term memory-focused speech therapy. These findings suggest that HD-tACS could help restore brain functions related to language. While more research is needed, early results are promising for those with language difficulties after a stroke. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05502822

High Definition Transcranial Alternating Current ... The purpose of this study was to explore the intervention effect of high definition transcranial alternating current stimulation in chronic post-stroke aphasia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805992/

The effect of transcranial alternating current stimulation on ... Our findings suggest that tACS improves functional recovery in patients with stroke. The application of tACS was associated with improved overall functional ...

3. trialx.com trialx.com/clinical-trials/listings/224404/transcranial-alternating-current-stimulation-tacs-for-the-recovery-of-phonological-short-term-memory-in-patients-with-aphasia-after-stroke/

Transcranial Alternating Current Stimulation (tACS) for the ... The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in stroke ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04375722

Transcranial Alternating Current Stimulation (tACS) in ... The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in aphasia. TACS differs from ...

5. scholarcommons.sc.edu scholarcommons.sc.edu/etd/7002/

"Transcranial Alternating Current Stimulation as an Adjuvant ... Preliminary data are encouraging and suggest that tACS may improve speech output for some speakers with nonfluent aphasia during a speech entrainment task.

6. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(22)00245-5/fulltext

A single-blind sham-controlled study - Brain Stimulation Transcranial alternating current stimulation enhances speech comprehension in chronic post-stroke aphasia patients: A single-blind sham-controlled study

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06092814

NCT06092814 | tACS to Enhance Language Abilities The goal of this study is to see if transcranial alternating current stimulation (tACS) can be used to enhance language abilities in people with post-stroke ...