TDCS + Phonomotor Therapy for Aphasia

Not yet recruiting at 1 trial location

Overseen By Olga Boukrina, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Blindness, Alzheimer's, Parkinson's, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist people with aphasia, a condition that often impairs speaking and understanding language after a stroke. It combines Phono-Motor Treatment (PMT), a language therapy, with transcranial direct current stimulation (tDCS), a gentle brain stimulation that may enhance learning. The trial aims to determine if adding tDCS to PMT improves reading skills more effectively than PMT alone. Individuals who had a stroke over six months ago, have been diagnosed with aphasia, and struggle with reading aloud may be suitable for this study. As an unphased study, this trial provides a unique opportunity to explore innovative treatments for aphasia.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this approach is safe for individuals with aphasia?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for stroke patients with language difficulties. In a review of studies, only 11.62% reported any side effects, most of which were mild, such as itching (70%) and a burning sensation. Another study confirmed that this brain stimulation method is noninvasive, safe, and painless. It uses a small electrical current that may enhance language skills when combined with speech therapy. Overall, tDCS appears promising, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Direct Current Stimulation (tDCS) combined with Phonomotor Therapy (PMT) for aphasia because it offers a non-invasive approach to enhance brain function. Unlike traditional speech and language therapies that focus solely on exercises, tDCS uses a mild electrical current to stimulate specific brain areas, potentially speeding up recovery. The trial explores different combinations: Early tDCS starts with active stimulation, Late tDCS introduces it after initial sham sessions, and Interleaved tDCS alternates active and sham sessions. This variety seeks to determine the most effective timing and combination, aiming for faster and more significant improvements in communication skills.

What evidence suggests that this trial's treatments could be effective for aphasia?

Research has shown that a gentle electrical brain stimulation technique called transcranial direct current stimulation (tDCS), when combined with language therapy, can help people with aphasia improve their language skills. In this trial, participants will join different groups to receive various combinations of tDCS and phonomotor therapy (PMT). Studies suggest that tDCS can enhance speech and communication, especially when paired with speech and language therapy. Evidence indicates that tDCS helps people with long-term aphasia name things more effectively than therapy alone. This suggests that adding tDCS to regular language therapy might lead to better reading and language recovery for those who have aphasia due to a stroke. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have aphasia, a language disorder often caused by stroke. Participants should struggle with reading due to their condition and are looking to improve their abilities through therapy.

Inclusion Criteria

I had a stroke in the left side of my brain over 6 months ago.

Deficits in reading aloud

I have been diagnosed with aphasia.

Exclusion Criteria

Contraindications of tDCS or MRI: Skin condition affecting the skull (e.g., psoriasis) or open wounds at the stimulation site, Presence of metallic implants (e.g., cardiac stimulators or pacemakers, cochlear implants), History of ongoing/unmanaged seizures, Pregnancy, Claustrophobia, Inability to lie flat on the back

I do not have severe speech issues or cognitive problems that prevent me from participating.

I do not have brain disorders like Alzheimer's, Dementia, or Parkinson's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different combinations of PMT and tDCS over six weeks, with assessments before, during, and after treatment

6 weeks

Multiple visits at two sites: Kessler Foundation and MCW

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests the effectiveness of combining Phono-Motor Treatment (PMT), a specialized language therapy for reading improvement, with transcranial direct current stimulation (tDCS), which uses mild electrical currents to potentially enhance learning.

How Is the Trial Designed?

Group I: Early tDCS Experimental Treatment 1 Intervention

This group will undergo Active tDCS + PMT for weeks 1-3 and Sham tDCS + PMT for weeks 4-6.

Group II: Interleaved tDCS Active Control 1 Intervention

This group will receive PMT + Active/Sham tDCS on alternate days for 6 weeks.

Group III: Late tDCS Placebo Group 1 Intervention

This group will undergo Sham tDCS + PMT for weeks 1-3 and Active tDCS + PMT for weeks 4-6.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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 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]

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 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]

In a study involving eight chronic non-fluent post-stroke aphasic patients, cathodal transcranial direct current stimulation (tDCS) significantly improved picture naming accuracy by an average of 33.6%.

Anodal and sham tDCS did not produce any noticeable changes in performance, suggesting that cathodal tDCS may be a promising technique for enhancing language recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved naming after transcranial direct current stimulation in aphasia. Monti, A., Cogiamanian, F., Marceglia, S., et al.[2022]

Transcranial direct current stimulation (tDCS) combined with speech and language treatment (SLT) is safe for stroke survivors with aphasia, showing no serious adverse events during a six-week treatment involving 30 sessions.

Participants receiving active tDCS exhibited greater improvements in functional language compared to those receiving sham treatment, suggesting that tDCS may enhance the effectiveness of SLT, although the superiority of one stimulation polarity over another remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial. Cherney, LR., Babbitt, EM., Wang, X., 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 involving a bilingual patient with chronic post-stroke aphasia, 9 sessions of anodal cerebellar transcranial direct current stimulation (ctDCS) combined with language therapy led to improvements in picture naming in both the patient's second language (L2) and first language (L1).

While both anodal ctDCS and sham treatment improved trained picture naming in L2, only the anodal ctDCS resulted in enhanced naming of untrained items and improved picture description in both languages, suggesting its potential as an effective tool for language rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: the effects of cerebellar tDCS in bilingual post-stroke aphasia. Coemans, S., Struys, E., Tsapkini, K., et al.[2023]

In a study of 14 individuals with post-stroke aphasia, transcranial direct current stimulation (tDCS) showed significant improvement in naming tasks, particularly in the Boston test, indicating its potential efficacy in language rehabilitation.

The study suggests that the placement of electrodes over specific brain areas can enhance recovery in patients with anomic and Broca's aphasia, highlighting the importance of considering language strategies in treatment assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: a study on naming performance in aphasic individuals. Silva, FRD., Mac-Kay, APMG., Chao, JC., et al.[2022]

Citations

1. 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319389/

Transcranial direct current stimulation to treat aphasia A number of studies have suggested that active transcranial direct current stimulation (A-tDCS) may improve treatment outcomes when coupled with behavioral ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-23-00312

Effectiveness of Transcranial Direct Current Stimulation as ... The weight of the evidence suggests that tDCS paired with SLT improves noun-naming outcomes in chronic aphasia beyond the effects of SLT alone.

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.01089/full

Transcranial Direct Current Stimulation to Enhance ... In summary, preliminary data suggest that anodal-tDCS can benefit naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.041557

Transcranial Direct-Current Stimulation in Subacute Aphasia This single-center, randomized, double-blind, sham-controlled efficacy trial tested the hypothesis that anodal tDCS augments language therapy in subacute ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ... Only 11.62% of published papers reported the occurrence of tDCS adverse effects in stroke patients. The most common was itching (70%), followed by burning ...

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-020-00708-z

Transcranial direct current stimulation (tDCS) for improving ... tDCS is an emerging approach for improving aphasia after stroke. However, it remains unclear what type of tDCS stimulation is most effective.

8. journals.lww.com journals.lww.com/md-journal/fulltext/2024/01120/the_effectiveness_and_safety_of_noninvasive_brain.53.aspx

The effectiveness and safety of noninvasive brain... The NIBS technique combined with speech training can effectively improve the recovery of language function in PSA patients with minimal adverse effects.