Neuro Device for Aphasia

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke 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 data supports the effectiveness of the treatment tACS for aphasia?

While there is no direct evidence for tACS in treating aphasia, similar treatments like transcranial direct current stimulation (tDCS) have shown promise in enhancing language recovery when combined with speech therapy, suggesting that non-invasive brain stimulation can support brain plasticity and language improvement. ^{1 2 3 4 5}

Is transcranial alternating current stimulation (tACS) safe for humans?

Transcranial alternating current stimulation (tACS) is generally considered safe for humans, with most adverse effects being mild and temporary, such as headaches or skin sensations. Serious adverse events are rare, and no persistent adverse events have been reported specifically for tACS. ^{6 7 8 9 10}

How is the treatment tACS different from other treatments for aphasia?

Transcranial Alternating Current Stimulation (tACS) is unique because it uses alternating electrical currents to modulate brain activity, which may offer a different mechanism of action compared to the more commonly studied Transcranial Direct Current Stimulation (tDCS) that uses a constant current. This novel approach could potentially provide new benefits for language recovery in aphasia patients. ^{5 11 12 13 14}

Research Team

Miguel Escalon, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

I am between 18 and 80 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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]

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 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 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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

No effects of anodal transcranial direct stimulation on language abilities in early rehabilitation of post-stroke aphasic patients. [2019]

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

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

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

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

4. 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]

5. 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]

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

Safety of 5 kHz tACS. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events of tDCS and tACS: A review. [2020]

8. India pubmed.ncbi.nlm.nih.gov

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

9. 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]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

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

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

12. 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]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Spinal or cortical direct current stimulation: Which is the best? Evidence from apraxia of speech in post-stroke aphasia. [2021]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Improved picture naming in aphasia patients treated with cathodal tDCS to inhibit the right Broca's homologue area. [2021]