tDCS for Speech Impairment After Stroke

Recruiting at 1 trial location

Overseen By Buchwald Lab

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Laryngeal voice disorder, Dysarthria, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining behavioral treatment with a gentle brain stimulation method, transcranial direct current stimulation (tDCS), can improve speech problems caused by a stroke. Participants will receive both real and sham brain stimulation to determine which is more effective. The trial is suitable for right-handed, English-speaking individuals who have experienced a single left-brain stroke, are at least six months post-stroke, and have been diagnosed with apraxia of speech (difficulty coordinating speech movements). As an unphased trial, it offers a unique opportunity to contribute to innovative research that may lead to new treatment options for speech recovery after a 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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for speech impairment after stroke?

Research shows that transcranial direct current stimulation (tDCS) is a safe and well-tolerated treatment. It uses a gentle electrical current to stimulate the brain. Studies have found that side effects are usually mild and temporary, such as slight skin irritation, meaning most people don't experience serious issues.

In stroke recovery, tDCS has been used successfully to improve arm movement without major risks. Medical research supports its safety, endorsing its use in various rehabilitation settings. While researchers continue to study tDCS for speech improvement, its success in other treatments suggests it is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Soterix 1x1 line tDCS stimulator because it offers a novel approach to treating speech impairment after a stroke. Unlike traditional speech therapy, which primarily relies on behavioral interventions, tDCS uses a low-intensity electrical current to directly stimulate specific areas of the brain, potentially enhancing neural plasticity and recovery. This non-invasive method can be applied alongside conventional therapy, potentially accelerating and amplifying patient outcomes. The crossover design, comparing active and sham stimulation, allows researchers to precisely evaluate the effectiveness of this innovative treatment.

What evidence suggests that tDCS is effective for speech impairment after stroke?

Research has shown that combining transcranial direct current stimulation (tDCS) with speech therapy can aid individuals with post-stroke aphasia. In this trial, participants will receive both active tDCS and sham stimulation in a crossover design to assess improvement differences based on treatment condition. tDCS is a safe, non-invasive method that uses a small electrical current to stimulate the brain. This technique has already demonstrated benefits in movement recovery, such as enhancing arm movement after a stroke. For speech difficulties, early research suggests that tDCS can enhance the effects of regular speech therapy. The treatment is generally safe and well-tolerated, offering a promising option for improving speech after a stroke. ^{1 2 4 6 7}

Who Is on the Research Team?

Adam Buchwald, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking individuals who have had a stroke at least six months ago and now have apraxia of speech. They must not have any voice disorders, other speech impairments from before the stroke, or risk factors that make tDCS unsafe like skin damage where the device goes, implants affected by electricity or magnets, metal inside their body, or a family history of epilepsy.

Inclusion Criteria

Monolingual (English)

I have been diagnosed with apraxia of speech.

You can hear and understand speech normally.

Exclusion Criteria

I have had seizures or unexplained fainting spells.

I have been diagnosed with a voice disorder affecting my larynx.

I have damaged skin where the stimulation device would be placed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral treatment combined with tDCS, including both active and sham stimulation in a crossover design

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham
• Soterix 1x1 line tDCS low-intensity stimulator

Trial Overview The study tests if adding brain stimulation with a Soterix low-intensity stimulator to regular speech therapy helps recovery in people with speech issues after a stroke. Some participants will get real stimulation (tDCS), while others receive sham treatment as a comparison; this is decided randomly.

How Is the Trial Designed?

Group I: Active Stimulation Experimental Treatment 2 Interventions

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

Group II: Sham Stimulation Placebo Group 2 Interventions

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

Soterix 1x1 line tDCS low-intensity stimulator is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as tDCS for:

• Stroke rehabilitation
• Motor disorders
• Aphasia

Approved in United States as tDCS for:

• Stroke rehabilitation
• Motor disorders
• Aphasia

Approved in Canada as tDCS for:

• Stroke rehabilitation
• Motor disorders
• Aphasia

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

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]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Transcranial direct current stimulation (tDCS) applied to Broca's area showed significant improvements in speech recovery for three patients with stroke-induced aphasia over a 2-week period, particularly during intensive language training sessions.

All subjects demonstrated better performance in articulatory tasks with anodic tDCS compared to sham stimulation, and these improvements were maintained at follow-up assessments, indicating potential long-term benefits of tDCS in speech recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation over the left inferior frontal gyrus (IFG) determines long-term effects in the recovery of speech apraxia in three chronic aphasics. Marangolo, P., Marinelli, CV., Bonifazi, S., et al.[2011]

In a study involving 14 adults who stutter, high-definition transcranial direct current stimulation (HD-tDCS) was tested to see if it could improve speech fluency during synchronized reading, but no significant differences were found between active and sham stimulation.

However, the results indicated that for individuals with more severe stuttering, active stimulation reduced the abnormal brain activity associated with their condition, suggesting that HD-tDCS may have potential for enhancing fluency in stuttering and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stuttering Severity Modulates Effects of Non-invasive Brain Stimulation in Adults Who Stutter. Garnett, EO., Chow, HM., Choo, AL., et al.[2020]

In a study involving 10 patients with poststroke aphasia, bihemispheric transcranial direct current stimulation (tDCS) combined with speech-language therapy did not significantly improve spontaneous speech, as measured by the number of different nouns used in responses.

Despite the lack of improvement in spontaneous speech or other cognitive functions, the study reported no adverse events, suggesting that bihemispheric tDCS is safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Combined Transcranial Direct Current Stimulation and Speech-language Therapy on Spontaneous Speech in Aphasia: A Randomized Controlled Double-blind Study. Guillouët, E., Cogné, M., Saverot, E., et al.[2021]

The study involving 26 healthy subjects found that five sessions of anodal transcranial direct current stimulation (tDCS) delivered over 24 hours were safe, with no serious adverse events reported, although mild side effects occurred in 27% of participants.

While 50% of subjects showed a significant increase in motor cortex excitability (as measured by motor evoked potential amplitudes), the response varied among individuals, indicating that not everyone benefits equally from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects on motor cortex excitability of five anodal transcranial direct current stimulation sessions in 24hours. Zappasodi, F., Musumeci, G., Navarra, R., et al.[2019]

Transcranial direct current stimulation (tDCS) shows promise as an adjuvant treatment for improving speech production in chronic stroke patients with aphasia, based on preliminary evidence.

Further research is needed to fully understand how tDCS works, its optimal application in language rehabilitation, and how it interacts with existing therapies to enhance long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can tDCS enhance treatment of aphasia after stroke? Holland, R., Crinion, J.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

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) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

A case study involving a child with cerebral palsy showed that combining transcranial direct current stimulation (tDCS) with integrative speech therapy led to significant improvements in speech, including an increase in the percentage of correct consonants and the ability to produce two- and three-syllable words.

The therapy involved two phases of tDCS targeting different brain areas, resulting in a notable increase in phoneme production, suggesting that tDCS can enhance the effectiveness of speech rehabilitation in children with speech impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation: A combined-therapy protocol for speech rehabilitation in a child with cerebral palsy. Lima, VLCC., Cosmo, C., Lima, KB., et al.[2022]

Non-invasive brain stimulation techniques, particularly low-frequency rTMS and cathodal tDCS, can significantly improve naming accuracy in patients with post-stroke aphasia, as shown in a meta-analysis of nine trials with 215 participants, yielding a moderate effect size of 0.51.

The application of these techniques to the non-language dominant hemisphere may promote neural reorganization and reduce competition between brain hemispheres, suggesting a promising adjunct to conventional speech and language therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory non-invasive brain stimulation to homologous language regions as an adjunct to speech and language therapy in post-stroke aphasia: a meta-analysis. Otal, B., Olma, MC., Flöel, A., et al.[2022]

A study involving 18 stroke patients found that a single session of transcranial direct current stimulation (tDCS) at currents up to 4 mA is safe and well-tolerated, with no major safety concerns reported.

While 50% of patients experienced mild, transient skin redness, there were no significant changes in skin temperature or body resistance, indicating that higher currents do not compromise skin integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Chhatbar, PY., Chen, R., Deardorff, R., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03452202

Using tDCS in Speech-based Stroke Rehabilitation The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral ...

2. soterixmedical.com soterixmedical.com/research/newsroom/clinicaltrials

Soterix Medical Clinical Trials This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol ...

3. soterixmedical.com soterixmedical.com/research/1x1/tdcs/device

1x1 tDCS Device – Transcranial Direct Current Stimulation The Soterix Medical 1x1 tDCS is the standard for precise and reproducible tDCS. Current intensity from 0.1 to 5 mA, and current duration from 5 to 40 minutes.

4. withpower.com withpower.com/trial/phase-apraxias-2019-d52fe

tDCS for Speech Impairment After Stroke Research shows that combining transcranial direct current stimulation (tDCS) with speech-language therapy can improve speech in people with post-stroke aphasia, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9521558/

Remotely monitored transcranial direct current stimulation in ... Remotely monitored tDCS, as an adjuvant intervention to rehabilitation, may improve quality of life for children with cerebral palsy (CP) ...

6. soterixmedical.com soterixmedical.com/research/1x1/tdcs/device/specs

1x1 tDCS Tech Specs Battery life (Fully charged batteries): 6 hrs ; Maximum Output Current: 5000 µA DC± 1% ; Maximum Output Voltage: 40V ± 5% ; Connector type: shielded banana.

7. soterixmedical.com soterixmedical.com/research/1x1/tdcs

tDCS Overview – Transcranial Direct Current Stimulation tDCS safety is supported by medical literature to have common side effects limited to mild and reversible skin irritation when using standard tDCS protocols and ...