Neuro Device for Aphasia

Recruiting at 2 trial locations

Overseen By Courtney McSweeney

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuro Device S.A

Must not be taking: Seizure medications

Disqualifiers: Severe cognitive impairment, Epilepsy, Pacemaker, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for aphasia, a language disorder often caused by a stroke. It uses a device called tACS (Transcranial Alternating Current Stimulation), which sends mild electrical currents to the brain while participants engage in language exercises. The trial includes two groups: one receives the real tACS treatment, and the other receives a sham (inactive) version. Individuals who have experienced a stroke resulting in aphasia, particularly Broca's or mixed types, and have difficulty with word-naming tasks might be eligible. The study aims to determine if tACS can improve communication skills in people with these specific language challenges. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance communication abilities for those with aphasia.

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that increase the risk of epileptic seizures, so you may need to stop such medications. The protocol does not specify other medication restrictions.

What prior data suggests that this neuro device is safe for treating aphasia?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe for patients. In one study, patients who received tACS showed noticeable improvements in their symptoms without an increase in serious side effects, suggesting that tACS is unlikely to cause harmful side effects. Another study examined individuals with long-term aphasia, a language disorder following a stroke, and found that tACS helped them better understand speech. These findings support the idea that tACS is a safe treatment option for those with post-stroke aphasia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial alternating current stimulation (tACS) for aphasia because it offers a new approach by using electrical currents to enhance brain activity, potentially improving language skills. Unlike traditional speech therapy or medications that target symptoms indirectly, tACS directly stimulates the brain, offering a more direct intervention. This method is complemented by language tasks and breathing exercises, which may enhance its effectiveness and offer a more holistic approach to treatment.

What evidence suggests that this neuro device is effective for aphasia?

Research has shown that transcranial alternating current stimulation (tACS) can aid individuals with aphasia, a condition affecting speech after a stroke. One study found that tACS improved blood flow and reduced stroke symptoms. Another study suggested that tACS could enhance language therapy, particularly in understanding speech. In this trial, participants will receive either real or sham tACS to evaluate its effectiveness. These findings suggest that tACS might help people regain language skills after a stroke. Overall, tACS appears promising as a therapy for improving speech and language abilities in individuals with aphasia. ^{1 2 3 4 6}

Who Is on the Research Team?

Miguel Escalon, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who have had a stroke over 6 months ago, resulting in aphasia (difficulty with language). They must have had their first stroke affecting the left hemisphere only and be able to perform certain language tasks at a basic level. Participants should not have severe cognitive impairments or unstable psychiatric conditions, epilepsy, metal implants in the skull, heart devices like pacemakers, or be pregnant.

Inclusion Criteria

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

I have been diagnosed with a type of speech difficulty by a speech therapist.

You can accurately name items only 10-60% of the time.

Exclusion Criteria

History of speech, language, hearing, or intellectual disability during childhood

Pregnancy (based on declarations)

You have a serious untreated mental health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 75Hz transcranial alternating current stimulation (tACS) paired with therapeutic linguistic tasks

12 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of naming tasks and quality of life

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tACS

Trial Overview The study tests if using tACS—a non-invasive brain stimulation technique—at a frequency of 75Hz can help improve language skills when combined with language therapy in people who've suffered from post-stroke aphasia.

How Is the Trial Designed?

Group I: Real tACS Active Control 1 Intervention

tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode.

Group II: Sham tACS Placebo Group 1 Intervention

tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode.

Who Is Running the Clinical Trial?

Neuro Device S.A

Lead Sponsor

Trials

1

Recruited

60+

Neuro Device Group S.A.

Lead Sponsor

Trials

1

Recruited

60+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Published Research Related to This Trial

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]

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 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 18 healthy volunteers, sinusoidal transcranial alternating current stimulation (tACS) at 5 kHz for 10 minutes at 1 mA was found to be safe, as indicated by stable neuron-specific enolase (NSE) levels and no significant changes in EEG or MRI results.

The findings suggest that tACS does not cause structural or pathological changes in the brain, supporting its safety for use under the tested conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 5 kHz tACS. Chaieb, L., Antal, A., Pisoni, A., et al.[2022]

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 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]

Transpinal direct current stimulation (tsDCS) combined with language training significantly improved speech recovery in patients with speech apraxia, as evidenced by better accuracy in repeating treated items after five days of treatment.

The positive effects of tsDCS persisted even one week after treatment and generalized to other language tasks, suggesting that spinal stimulation could be a promising new method for language rehabilitation in post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal or cortical direct current stimulation: Which is the best? Evidence from apraxia of speech in post-stroke aphasia. Pisano, F., Caltagirone, C., Incoccia, C., et al.[2021]

In a study involving 10 right-handed patients with post-stroke aphasia, cathodal transcranial DC stimulation (ctDCS) applied to the right Broca's homologue area significantly improved picture naming skills, as measured by the Boston Naming Test, one hour after treatment.

The ctDCS treatment was safe, with no adverse effects reported, and showed a significant improvement in naming tasks compared to sham stimulation, indicating its potential as a therapeutic intervention for speech production in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved picture naming in aphasia patients treated with cathodal tDCS to inhibit the right Broca's homologue area. Kang, EK., Kim, YK., Sohn, HM., 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]

Transcranial direct current stimulation (tDCS) is generally considered safe, with most adverse effects being mild and temporary; however, some cases of persistent skin lesions and rare instances of mania or hypomania have been reported, particularly in patients with depression.

Transcranial alternating current stimulation (tACS) has fewer reported adverse events, and no persistent effects have been documented, but more research is needed to fully establish its safety compared to tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of tDCS and tACS: A review. Matsumoto, H., Ugawa, Y.[2020]

In a study involving 37 participants with moderate to severe aphasia, repeated anodal transcranial direct current stimulation (A-tDCS) did not show a significant positive impact on language recovery when combined with language therapy, compared to a sham stimulation group.

Both groups showed improvement in language abilities after therapy, but there were no statistically significant differences in outcomes between the A-tDCS and control groups, indicating that A-tDCS may not provide functional benefits in early post-stroke rehabilitation for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No effects of anodal transcranial direct stimulation on language abilities in early rehabilitation of post-stroke aphasic patients. Polanowska, KE., Leśniak, M., Seniów, JB., et al.[2019]

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]

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]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Citations

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

The effect of transcranial alternating current stimulation on ... The results demonstrated that the tACS group had a significant decrease in mean NIHSS scores, a larger increase in blood flow velocity, and a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04375722

Transcranial Alternating Current Stimulation (tACS) in ... This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000885

Effect of transcranial direct current stimulation combined ... tDCS combined with SLT demonstrates potential enhancement in language recovery on post-ischemic stroke aphasia. The combination may augment speech content, ...

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

A single-blind sham-controlled study We predicted that tACS over SMA would enhance the efficacy of SLT in chronic post-stroke aphasia, especially for improving speech comprehension.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04375722/transcranial-alternating-current-stimulation-tacs-in-aphasia

Transcranial Alternating Current Stimulation (tACS) in ... This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy ...

6. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000212378

Tuning the Brain for Language: Exploring tACS as a ... Speech-language therapy is the current mainstay of aphasia treatment, but residual language impairments persist, limiting quality of life.