Neuro Device for Aphasia
Recruiting in Palo Alto (17 mi)
+1 other location
ME
Overseen byMiguel Escalon, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neuro Device S.A
Must not be taking: Seizure medications
Disqualifiers: Severe cognitive impairment, Epilepsy, Pacemaker, others
No Placebo Group
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.12345
Is transcranial alternating current stimulation (tACS) safe for humans?
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.511121314
Research Team
ME
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.
See 5 more
Exclusion Criteria
History of speech, language, hearing, or intellectual disability during childhood
Pregnancy (based on declarations)
You have a serious untreated mental health condition.
See 8 more
Trial 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 (Neurostimulation Device)
Trial OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: Real tACSActive Control1 Intervention
tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode.
Group II: Sham tACSPlacebo Group1 Intervention
tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Abilities Research CenterNew York, NY
Abilities Research Center at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Neuro Device S.A
Lead Sponsor
Trials
1
Patients Recruited
60+
Neuro Device Group S.A.
Lead Sponsor
Trials
1
Patients Recruited
60+
Icahn School of Medicine at Mount Sinai
Collaborator
Trials
933
Patients 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]
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]
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]
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]
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety of 5 kHz tACS.Chaieb, L., Antal, A., Pisoni, A., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse events of tDCS and tACS: A review.Matsumoto, H., Ugawa, Y.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy.Duncan, ES., Nakkawita, SG.[2022]
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]
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]
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
No effects of anodal transcranial direct stimulation on language abilities in early rehabilitation of post-stroke aphasic patients. [2019]
Effects of dual transcranial direct current stimulation for aphasia in chronic stroke patients. [2021]
Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. [2023]
The Factors Associated with Good Responses to Speech Therapy Combined with Transcranial Direct Current Stimulation in Post-stroke Aphasic Patients. [2021]
Translational treatment of aphasia combining neuromodulation and behavioral intervention for lexical retrieval: implications from a single case study. [2020]
Safety of 5 kHz tACS. [2022]
Adverse events of tDCS and tACS: A review. [2020]
Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. [2022]
Transcranial direct current stimulation (tDCS) for improving aphasia after stroke: a systematic review with network meta-analysis of randomized controlled trials. [2020]
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]
Effect of Anodic Transcranial Direct Current Stimulation Combined With Speech Language Therapy on Nonfluent Poststroke Aphasia. [2022]
Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial. [2021]
Spinal or cortical direct current stimulation: Which is the best? Evidence from apraxia of speech in post-stroke aphasia. [2021]
Improved picture naming in aphasia patients treated with cathodal tDCS to inhibit the right Broca's homologue area. [2021]