tDCS + SLT for Post-Stroke Aphasia
Recruiting in Palo Alto (17 mi)
Overseen byDana Moser, PhD, CCC-SLP
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arkansas
Disqualifiers: Neurological disease, Major mental illness, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose this study is to test the utility of pairing external neuromodulation with behavioral language treatment to boost therapy outcomes and to investigate the mechanisms associated with recovery. Because all PWA have word retrieval deficits, this project will test if greater language gains can be achieved by supplementing anomia intervention with excitatory brain stimulation to the left hemisphere and will evaluate associated functional brain changes to aid the optimization of neural reorganization to facilitate language processing.
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 data supports the effectiveness of the treatment tDCS + SLT for Post-Stroke Aphasia?
Research shows that combining transcranial direct current stimulation (tDCS) with speech language therapy (SLT) can help improve language skills in people who have trouble speaking after a stroke. Studies suggest that tDCS can enhance the effects of SLT, making it a promising approach for treating aphasia (language impairment) in stroke patients.
12345Is tDCS combined with SLT safe for humans?
Research indicates that transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) is generally safe for humans, with no serious adverse events reported in studies involving stroke survivors with aphasia.
35678How is the tDCS + SLT treatment for post-stroke aphasia different from other treatments?
The tDCS + SLT treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with speech and language therapy (SLT) to enhance language recovery in stroke survivors with aphasia. Unlike standard treatments, this approach targets the brain's language areas directly and has shown potential for greater language improvement when used over an extended period.
12369Eligibility Criteria
This trial is for individuals aged 18-80 who have had a stroke on the left side of their brain at least 6 months ago, resulting in aphasia. They must speak English natively and have good hearing and vision. People with severe comprehension deficits, other neurological diseases or major mental illnesses, conditions not suitable for MRI or tDCS (like seizures), or pregnant women cannot participate.Inclusion Criteria
I had a stroke that affected the left side of my brain.
I can see and hear well enough to do tasks.
It has been over 6 months since my stroke.
+3 more
Exclusion Criteria
If you are a woman, you are pregnant.
You have a history of serious mental health conditions like schizophrenia, drug addiction, or bipolar disorder.
I have a history of a brain-related condition or injury.
+3 more
Trial Timeline
Baseline Assessment
Participants complete the Neuropsychological Testing Battery and the first round of outcome measures as pre-testing before starting SLT
1 week
1 visit (in-person)
Intervention Phase 1
Participants receive 2 weeks of Speech-Language Therapy (SLT) with either active tDCS or sham tDCS
2 weeks
Multiple visits (in-person)
Outcome Testing 1
Participants complete post-testing for the 1st SLT phase and pre-testing for the 2nd SLT phase
1 week
1 visit (in-person)
Intervention Phase 2
Participants receive another 2 weeks of SLT with the other tDCS condition
2 weeks
Multiple visits (in-person)
Outcome Testing 2
Participants complete post-testing for the 2nd SLT phase
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
10 weeks
1 visit (in-person)
Participant Groups
The study is examining if using Transcranial Direct Current Stimulation (tDCS) alongside Speech-Language Therapy (SLT) can improve language skills better than SLT alone in people with aphasia after a stroke. It also looks at how the brain changes functionally during this process.
2Treatment groups
Active Control
Placebo Group
Group I: Active tDCS (with Speech-Language Treatment)Active Control1 Intervention
tDCS Stimulation Dose: 1.5 mA for 20-mins
Group II: Sham tDCS (with Speech-Language Treatment)Placebo Group1 Intervention
No tDCS stimulation
Active Transcranial Direct Current Stimulation with SLT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as tDCS for:
- Post-stroke aphasia rehabilitation
🇺🇸 Approved in United States as tDCS for:
- Post-stroke aphasia rehabilitation
🇨🇦 Approved in Canada as tDCS for:
- Post-stroke aphasia rehabilitation
🇯🇵 Approved in Japan as tDCS for:
- Post-stroke aphasia rehabilitation
🇨🇳 Approved in China as tDCS for:
- Post-stroke aphasia rehabilitation
🇨🇭 Approved in Switzerland as tDCS for:
- Post-stroke aphasia rehabilitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Arkansas for Medical SciencesLittle Rock, AR
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Who Is Running the Clinical Trial?
University of ArkansasLead Sponsor
References
The Factors Associated with Good Responses to Speech Therapy Combined with Transcranial Direct Current Stimulation in Post-stroke Aphasic Patients. [2021]To determine factors associated with good responses to speech therapy combined with transcranial direct current stimulation (tDCS) in aphasic patients after stroke.
Effects of dual transcranial direct current stimulation for aphasia in chronic stroke patients. [2021]To investigate any additional effect of dual transcranial direct current stimulation (tDCS) compared with single tDCS in chronic stroke patients with aphasia.
Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. [2023]Transcranial direct-current stimulation (tDCS) is a promising adjunct to therapy for chronic aphasia.
Effect of Anodic Transcranial Direct Current Stimulation Combined With Speech Language Therapy on Nonfluent Poststroke Aphasia. [2022]Transcranial direct current stimulation (tDCS) facilitates or inhibits spontaneous neuronal activity by low-intensity current. In this study, we evaluated the effects of tDCS and sham stimulation combined with speech language therapy (SLT) on nonfluent poststroke aphasia (PSA) patients.
Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial. [2021]Transcranial direct-current stimulation (tDCS) has been used to modulate and induce changes in brain function and excitability. tDCS is a promising tool for the treatment of aphasia.
Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial. [2021]Transcranial direct current stimulation (tDCS) may enhance speech and language treatment (SLT) for stroke survivors with aphasia; however, to date, there is no standard protocol for the application of tDCS in post-stroke aphasia. We explored the safety and efficacy of fMRI-guided tDCS on functional language and cortical activity when delivered to the lesioned left hemisphere concurrently with SLT across an extended, six-week treatment period. Twelve persons with chronic, nonfluent aphasia following a single left-hemisphere stroke participated in the three-arm (anodal vs. cathodal vs. sham) single-blind, parallel, pilot trial. No serious adverse events occurred during 30 treatment sessions or in the following six weeks. All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham. Evidence declaring one polarity as superior for inducing language recovery was mixed. However, cathodal stimulation to the lesioned left hemisphere, expected to have a down-regulating effect, resulted in increased areas of cortical activation across both hemispheres, and specifically perilesionally. Generalization of these preliminary findings is limited; however, results are nevertheless compelling that tDCS combined with SLT can be safely applied across extended durations, with the potential to enhance functional language and cortical activation for persons with aphasia.
Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. [2022]Transcranial direct current stimulation (tDCS) is a safe, portable, and inexpensive form of noninvasive brain stimulation that appears to augment the effects of concurrent therapy. However, several methodological issues in existing studies distance tDCS from current clinical practice. In this study, we offered (and administered) tDCS to individuals seeking typical behavioral aphasia therapy on an outpatient basis.
Transcranial direct current stimulation (tDCS) for improving aphasia after stroke: a systematic review with network meta-analysis of randomized controlled trials. [2020]Transcranial Direct Current Stimulation (tDCS) is an emerging approach for improving aphasia after stroke. However, it remains unclear what type of tDCS stimulation is most effective. Our aim was to give an overview of the evidence network regarding the efficacy and safety of tDCS and to estimate the effectiveness of the different stimulation types.
Improved naming after transcranial direct current stimulation in aphasia. [2022]Transcranial direct current stimulation (tDCS) has been proposed as an adjuvant technique to improve functional recovery after ischaemic stroke. This study evaluated the effect of tDCS over the left frontotemporal areas in eight chronic non-fluent post-stroke aphasic patients. The protocol consisted of the assessment of picture naming (accuracy and response time) before and immediately after anodal or cathodal tDCS (2 mA, 10 minutes) and sham stimulation. Whereas anodal tDCS and sham tDCS failed to induce any changes, cathodal tDCS significantly improved the accuracy of the picture naming task by a mean of 33.6% (SEM 13.8%).