Brain Stimulation for Speech Disorders

Overseen By Jill Ritter, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Implanted device, Skull defects, Pregnant, Arrhythmia, Epileptic seizures, 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: 12

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a gentle electrical treatment called transcranial direct current stimulation (tDCS) can assist individuals with speech and language problems caused by conditions like primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). Researchers will apply tDCS to specific brain areas to enhance speech and other cognitive functions. Two treatment paths exist: one targets the brain's pre-supplementary motor area, and the other focuses on the left inferior frontal gyrus. Individuals diagnosed with PPA or PAOS who are not currently receiving speech-language therapy might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for speech and language challenges.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for improving speech and language difficulties?

Research shows that transcranial direct current stimulation (tDCS) safely and non-invasively aids brain function. It gently sends a small electrical current to specific brain areas. Studies have found that tDCS can improve language skills in individuals with conditions like primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS).

In past studies, patients generally tolerated tDCS well. Most people experienced only mild side effects, such as slight tingling on the scalp where electrodes are placed. Rare cases of headaches or skin irritation occurred, but these effects usually didn't last long. The treatment doesn't involve surgery or medications, reducing the risk of serious side effects.

Overall, tDCS is considered a low-risk treatment option. Researchers continue to study its full potential, but current evidence supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about transcranial direct current stimulation (tDCS) for speech disorders like primary progressive aphasia and progressive apraxia of speech because it offers a novel approach compared to traditional speech therapy. Unlike standard treatments that rely on behavioral therapy to improve speech, tDCS uses a mild electrical current to stimulate specific brain areas involved in speech production. This technology is non-invasive and can potentially enhance brain plasticity, leading to improved speech output and verbal fluency. The treatment targets either the pre-supplementary motor area or the left inferior frontal gyrus, which are critical brain regions for speech and language, possibly offering faster and more effective results.

What evidence suggests that transcranial direct current stimulation could be effective for speech disorders?

Research has shown that transcranial Direct Current Stimulation (tDCS) may help treat speech and language problems in conditions like primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). In this trial, participants will receive one of two active tDCS treatments. The Active Pre-SMA tDCS treatment stimulates the pre-supplementary motor area, while the Active LIFG tDCS treatment targets the left inferior frontal gyrus. Studies have found that tDCS can improve language skills in people with PPA, and early evidence suggests it might enhance the effects of speech therapy for apraxia of speech. This treatment uses a gentle electrical current to stimulate specific brain areas involved in language. Overall, tDCS is becoming a promising option for improving language abilities in these conditions. ^{3 6 7 8 9}

Who Is on the Research Team?

John Hart, MD

Principal Investigator

University of Texas at Dallas

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with primary progressive aphasia or apraxia of speech, who can consent to participate. It's not suitable for those currently in speech therapy, with implanted devices like pacemakers, skull defects, non-native English speakers, a history of seizures or arrhythmias, or if pregnant.

Inclusion Criteria

I have been diagnosed with a specific type of speech disorder.

I understand the study and can sign the consent myself, or I have a caregiver who can help.

Exclusion Criteria

Pregnant

Has an implanted device, such as a pacemaker, metallic cranial implant, or a neurostimulator

English is not my first language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 milliamp transcranial direct current stimulation (tDCS) applied to pre-supplementary motor area or left inferior frontal gyrus for 20 minutes over 10 sessions

2 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments immediately after and 8 weeks post-treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial direct current stimulation

Trial Overview The study tests if transcranial direct current stimulation (tDCS) on the brain area linked to memory can help improve speech and language issues in patients with aphasia and apraxia of speech. Speech/language functions are primarily measured alongside other cognitive abilities and EEG readings.

How Is the Trial Designed?

Group I: Active Pre-SMA tDCS treatment Experimental Treatment 1 Intervention

This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

Group II: Active LIFG tDCS treatment Experimental Treatment 1 Intervention

This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

Transcranial direct current stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in European Union as tDCS for:

• Major depressive disorder
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in Canada as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Published Research Related to This Trial

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]

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]

In a study involving 60 healthy young participants, transcranial direct current stimulation (tDCS) did not significantly improve performance on a complex speech motor learning task (repetition of tongue twisters) compared to sham stimulation, suggesting limited efficacy in this context.

Motor excitability in the speech motor cortex showed a small decrease across all stimulation groups, but this change was not significantly different among the groups and did not correlate with task performance, indicating that tDCS may not effectively modulate cortical excitability in young, healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of tDCS to modulate motor excitability and speech motor learning. Wiltshire, CEE., Watkins, KE.[2022]

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]

Transcranial direct current stimulation (tDCS) over the left inferior frontal gyrus (IFG) significantly improved sound duration in patients with apraxia of speech (AOS) symptoms associated with non-fluent primary progressive aphasia (nfvPPA), showing benefits even two months after treatment.

The study involved eight patients receiving either active or sham tDCS alongside speech therapy, and the results indicated that tDCS not only enhanced speech production during therapy but also generalized to untrained words, suggesting it may enhance the effectiveness of speech therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tDCS on Sound Duration in Patients with Apraxia of Speech in Primary Progressive Aphasia. Themistocleous, C., Webster, K., Tsapkini, K.[2022]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

This study presents the first case of safely administering electroconvulsive therapy (ECT) to a patient with deep brain stimulation (DBS) by temporarily interrupting DBS only during the ECT sessions.

Previous reports indicated no adverse events when DBS was withheld for the entire ECT course, but this case suggests that short interruptions during ECT may be a safe approach, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary interruption of deep brain stimulation for Parkinson's disease during outpatient electroconvulsive therapy for major depression: a novel treatment strategy. Ducharme, S., Flaherty, AW., Seiner, SJ., et al.[2011]

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) significantly improved motor symptoms in a 44-year-old woman with Parkinson's disease, but also caused uncontrollable laughter, highlighting the potential for neurobehavioral side effects.

The use of directional electrodes allowed for more precise stimulation, which helped to minimize undesirable side effects while optimizing motor improvement, suggesting that careful programming and electrode placement are crucial for effective DBS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. Alonso-Frech, F., Fernandez-Garcia, C., Gómez-Mayordomo, V., et al.[2022]

A review of 21 cases and a new case study at the University of Maryland Medical Center suggest that electroconvulsive therapy (ECT) can be safely administered to patients with implanted deep brain stimulators when proper precautions are taken.

No adverse events related to the deep brain stimulation device were reported in the literature, indicating that ECT does not pose a safety risk for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Electroconvulsive Therapy in Patients With Implanted Deep Brain Stimulators: A Review of the Literature and Case Report. Peroski, MS., Chu, MM., Doddi, SR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8530184/

A Systematic Review of Transcranial Direct Current ... We found that studies of tDCS in PPA have clinical and methodological and heterogeneity regarding patient populations, stimulation protocols and study design.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8000042/

Effects of tDCS on Sound Duration in Patients with Apraxia of ... The results provide preliminary evidence that tDCS may maximize efficacy of speech therapy in patients with nfvPPA/AOS. Keywords: apraxia of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0149763425002659

Linguistic effects of transcranial Direct Current Stimulation ... Transcranial Direct Current Stimulation (tDCS) has shown promising language improvements in patients with primary progressive aphasia (PPA).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05386394

NCT05386394 | Transcranial Direct Current Stimulation in ... Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges.

5. mdpi.com mdpi.com/2076-3425/15/8/839

Efficacy of Transcranial Magnetic Stimulation and ... Conclusions: rTMS and tDCS applied with or without concomitant language treatment appear to be promising interventions for enhancing language abilities in PPA, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05386394

Transcranial Direct Current Stimulation in the Treatment of ... Each treatment period will last 3 weeks, with 5 language therapy sessions/week, for 15 sessions in total, and a 3-month (stimulation-free) wash-out time between ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12484069/

High-definition brain stimulation targeting separate regions ... A systematic review of transcranial direct current stimulation in primary progressive aphasia: methodological considerations. Front Aging ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03887481

Study Details | NCT03887481 | Targeting Language- ... Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2213158218301682

The effect of tDCS on functional connectivity in primary ... Transcranial direct current stimulation (tDCS) is an innovative technique recently shown to improve language outcomes even in neurodegenerative conditions ...