130 Participants NeededMy employer runs this trial

tDCS for Expressive Aphasia

(STARS Trial)

Recruiting at 2 trial locations
LB
JF
Overseen ByJulius Fridriksson
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, can enhance language recovery in individuals with Broca's aphasia, which impairs speech after a stroke. The study compares two different tDCS intensities and a placebo version to determine the most effective option alongside traditional speech therapy. It targets those who experienced a stroke over six months ago and have Broca's aphasia, affecting their speech and language comprehension. Participants must have used English as their primary language for over 15 years.

As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. It offers participants a chance to contribute to potentially groundbreaking advancements in stroke recovery therapies.

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 study team or your doctor.

What prior data suggests that transcranial Direct Current Stimulation (tDCS) is safe for treating expressive aphasia?

Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe. This non-invasive treatment uses gentle electrical currents to stimulate the brain and is usually well-tolerated. Specifically, tDCS has been safely used to improve language skills in people with aphasia.

Studies suggest that 1 mA and 2 mA tDCS treatments are painless and have only minor side effects when used properly. These side effects might include slight tingling or skin redness, which are usually temporary. Both levels of stimulation have shown promise in enhancing language recovery when combined with speech therapy.

Overall, evidence suggests that tDCS is a safe option for those considering clinical trials aimed at improving language function in aphasia.12345

Why are researchers excited about this trial's treatments for aphasia?

Researchers are excited about transcranial Direct Current Stimulation (tDCS) for expressive aphasia because it offers a unique, non-invasive approach to enhancing language recovery. Unlike traditional speech therapy, which relies solely on behavioral techniques, tDCS involves applying a mild electrical current to specific brain regions to potentially boost neural activity and connectivity. This method could complement existing therapies by directly targeting the brain's language centers, potentially accelerating recovery and improving outcomes for patients struggling with speech production.

What evidence suggests that transcranial Direct Current Stimulation (tDCS) is effective for Broca's aphasia?

This trial will compare different approaches to using transcranial Direct Current Stimulation (tDCS) for expressive aphasia. Studies have shown that combining tDCS with speech therapy can significantly enhance language skills in individuals with aphasia, a condition affecting speaking and understanding language. One study reported a 32.6% improvement in speaking, understanding, and reading when tDCS was added to therapy. This suggests that tDCS may enhance the effectiveness of traditional speech therapy. However, some research indicates that not everyone fully recovers, and some language difficulties may persist. Overall, the results are promising and suggest that tDCS could be a valuable addition for helping individuals with aphasia regain language skills.24678

Are You a Good Fit for This Trial?

This trial is for adults who have Broca's aphasia (difficulty speaking after a stroke). Participants should be able to take part in speech therapy and not have conditions that would make brain stimulation unsafe, such as certain metal implants or seizures.

Inclusion Criteria

Be greater than 6 months post-stroke
I am between 25 and 80 years old.
Be willing and able to give informed consent
See 5 more

Exclusion Criteria

Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test)
I have skin problems like rash or wounds near where electrodes would be placed.
I have had seizures in the past 12 months.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase II Treatment

Participants receive auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) to determine the optimal dose (1 mA versus 2 mA) and provide a go/no-go decision for Phase III

4 weeks

Phase III Treatment

Participants receive the definitive treatment with the optimal dose of adjuvant A-tDCS coupled with speech therapy to test superiority over sham tDCS

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of aphasia severity, functional communication, quality of life, and communication confidence

4 weeks

Extended Follow-up

Participants are monitored for naming improvements at 24-weeks post treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • transcranial Direct Current Stimulation (tDCS)

Trial Overview

The study compares two groups: one receives both tDCS (a gentle electrical brain stimulation) and speech therapy, while the other gets only speech therapy. The goal is to see if adding tDCS helps improve language recovery more than speech therapy alone.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: 1 mA A-tDCSActive Control1 Intervention
Group II: 2 mA A-tDCSActive Control1 Intervention
Group III: S-tDCSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials
233
Recruited
122,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

tDCS and Speech Therapy in Aphasia Treatment - PMC - NIH

Group III showed the greatest gains in verbal expression, comprehension, and reading (32.6% improvement in FAST scores), significantly outperforming Group I ( ...

Transcranial Direct-Current Stimulation and Behavioral ...

tDCS has led to promising results in rehabilitating patients with acquired aphasia, especially if combined with different language and communication therapies.

Effects of Transcranial Direct Current Stimulation (tDCS) on ...

several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits

tDCS and Speech Therapy in Aphasia Treatment: A ...

Group III showed the greatest gains in verbal expression, comprehension, and reading (32.6% improvement in FAST scores), significantly ...

Cerebellar transcranial direct current stimulation improves ...

In healthy participants, cerebellar tDCS has led to improvements in verbal fluency16 and verb generation26. Similarly, in post-stroke aphasia, ...

Timing of transcranial direct current stimulation (tDCS ... - PMC

Recent research suggests that language recovery in individuals with aphasia can be boosted by pairing SLT with a non-invasive, safe, and low-cost form of brain ...

Transcranial Direct-Current Stimulation in Subacute Aphasia

tDCS is a safe, noninvasive, nonpainful electrical stimulation of the brain, patients with chronic aphasia. 20 to 30 seconds.

tDCS to Recover Language in Aphasia

tDCS offers a non-invasive and safe method to stimulate specific brain regions associated with language processing, such as Broca's area and Wernicke's area.