Cerebellar tDCS + Language Therapy for Aphasia
(CeSAR Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Seizure threshold reducers, NMDA antagonists
Disqualifiers: Right cerebellum lesion, Seizures, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The optimal site of neuromodulation for post-stroke aphasia has yet to be established. This study will investigate whether multiple sessions of cerebellar transcranial direct current stimulation (tDCS) boosts language therapy in helping people recover from aphasia as well as predict who is likely to respond to cerebellar tDCS.
Do I need to stop taking my current medications for the trial?
You may need to stop taking certain medications, especially those that lower the seizure threshold or NMDA antagonists, as they are listed in the exclusion criteria.
What data supports the effectiveness of the treatment Cathodal Cerebellar tDCS for aphasia?
Research shows that cathodal tDCS can improve language abilities in post-stroke aphasic patients, such as enhancing picture naming accuracy by 33.6%. Additionally, tDCS has been found to augment language outcomes in aphasia, suggesting it may be a useful tool when combined with language therapy.
12345Is cathodal cerebellar tDCS safe for humans?
Research on cathodal tDCS, including studies on post-stroke aphasia, suggests it is generally safe, with no serious adverse events reported during treatment sessions.
12467How does the cerebellar tDCS + language therapy treatment for aphasia differ from other treatments?
Cerebellar tDCS (transcranial direct current stimulation) combined with language therapy is unique because it targets the cerebellum, a part of the brain not traditionally associated with language, to enhance language recovery in aphasia patients. This approach is novel as it uses electrical stimulation to potentially improve language skills more effectively than standard language therapy alone, especially for untrained language tasks.
128910Eligibility Criteria
This trial is for English-speaking adults over 18 who had a stroke in the left hemisphere of their brain at least 6 months ago, resulting in aphasia and difficulty naming things. They must have been right-handed before the stroke. People with cerebellum damage, other neurological or psychiatric disorders, recent seizures, severe sensory loss, certain medication use, high baseline naming test scores, metal in their head or body implants are excluded.Inclusion Criteria
Fluent speaker of English by self-report
I had a stroke in the left side of my brain.
I am 18 years old or older.
+2 more
Exclusion Criteria
I have had brain surgery or have metal in my head.
Individuals with severe claustrophobia, cardiac pacemakers or ferromagnetic implants, and pregnant women will be excluded from the MRI portion of the study.
I am taking medication that could increase my risk of seizures.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 15 sessions of cerebellar tDCS combined with Semantic Feature Analysis (SFA) over 3-5 weeks
3-5 weeks
15 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Follow-up assessments at 1 week, 1 month, 3 months, and 6 months post-treatment
Participant Groups
The study tests if cerebellar tDCS—a non-invasive brain stimulation—combined with language therapy (Semantic Feature Analysis) helps people recover from post-stroke aphasia better than sham (fake) treatment. It also aims to identify which patients might benefit most from this approach.
2Treatment groups
Active Control
Placebo Group
Group I: Cathodal Cerebellar tDCS and SFAActive Control2 Interventions
Cathodal cerebellar tDCS, 2 milliamp (mA) plus Semantic Feature Analysis (SFA) naming treatment for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes. SFA will be delivered by a Speech and Language Pathologist to improve naming
Group II: Sham Cerebellar tDCS and SFAPlacebo Group2 Interventions
Sham cerebellar tDCS plus SFA for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SFA will be delivered by a Speech and Language Pathologist to improve naming.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
Johns Hopkins HospitalBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
Connectivity between right inferior frontal gyrus and supplementary motor area predicts after-effects of right frontal cathodal tDCS on picture naming speed. [2016]Cathodal transcranial direct current stimulation (tDCS) of the right frontal cortex improves language abilities in post-stroke aphasic patients. Yet little is known about the effects of right frontal cathodal tDCS on normal language function.
Case report: the effects of cerebellar tDCS in bilingual post-stroke aphasia. [2023]Transcranial Direct Current Stimulation may be a useful neuromodulation tool for enhancing the effects of speech and language therapy in people with aphasia, but research so far has focused on monolinguals. We present the effects of 9 sessions of anodal cerebellar tDCS (ctDCS) coupled with language therapy in a bilingual patient with chronic post-stroke aphasia caused by left frontal ischemia, in a double-blind, sham-controlled within-subject design. Language therapy was provided in his second language (L2). Both sham and anodal treatment improved trained picture naming in the treated language (L2), while anodal ctDCS in addition improved picture naming of untrained items in L2 and his first language, L1. Picture description improved in L2 and L1 after anodal ctDCS, but not after sham.
Transcranial direct current stimulation in post stroke aphasia and primary progressive aphasia: Current knowledge and future clinical applications. [2019]The application of transcranial direct current stimulation (tDCS) in chronic post stroke aphasia is documented in a substantial literature, and there is some new evidence that tDCS can augment favorable language outcomes in primary progressive aphasia. Anodal tDCS is most often applied to the left hemisphere language areas to increase cortical excitability (increase the threshold of activation) and cathodal tDCS is most often applied to the right hemisphere homotopic areas to inhibit over activation in contralesional right homologues of language areas. Outcomes usually are based on neuropsychological and language test performance, following a medical model which emphasizes impairment of function, rather than a model which emphasizes functional communication.
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%).
Combining Voxel-based Lesion-symptom Mapping (VLSM) With A-tDCS Language Treatment: Predicting Outcome of Recovery in Nonfluent Chronic Aphasia. [2019]Most of transcranial direct current stimulation (tDCS) studies in aphasia have already shown that significant changes in language performance could be improved by increased monitoring of the perilesional cortex in the left lesioned hemisphere with excitatory anodal tDCS (A-tDCS). However, no report to date has investigated which areas may be less predictable or may play a major role in the recovery from language impairment after brain stimulation.
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.
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.
Cerebellar neuromodulation improves naming in post-stroke aphasia. [2023]Transcranial direct current stimulation has been shown to increase the efficiency of language therapy in chronic aphasia; however, to date, an optimal stimulation site has not been identified. We investigated whether neuromodulation of the right cerebellum can improve naming skills in chronic aphasia. Using a randomized, double-blind, sham-controlled, within-subject crossover study design, participants received anodal cerebellar stimulation (n = 12) or cathodal cerebellar stimulation (n = 12) + computerized aphasia therapy then sham + computerized aphasia therapy, or the opposite order. There was no significant effect of treatment (cerebellar stimulation versus sham) for trained naming. However, there was a significant order x treatment interaction, indicating that cerebellar stimulation was more effective than sham immediately post-treatment for participants who received cerebellar stimulation in the first phase. There was a significant effect of treatment (cerebellar stimulation versus sham) for untrained naming immediately post-treatment and the significant improvement in untrained naming was maintained at two months post-treatment. Greater gains in naming (relative to sham) were noted for participants receiving cathodal stimulation for both trained and untrained items. Thus, our study provides evidence that repetitive cerebellar transcranial direct stimulation combined with computerized aphasia treatment can improve picture naming in chronic post-stroke aphasia. These findings suggest that the right cerebellum might be an optimal stimulation site for aphasia rehabilitation and this could be an answer to handle heterogeneous participants who vary in their size and site of left hemisphere lesions.
Transcranial Cerebellar Direct Current Stimulation Enhances Verb Generation but Not Verb Naming in Poststroke Aphasia. [2018]Although the role of the cerebellum in motor function is well recognized, its involvement in the lexical domain remains to be further elucidated. Indeed, it has not yet been clarified whether the cerebellum is a language structure per se or whether it contributes to language processing when other cognitive components (e.g., cognitive effort, working memory) are required by the language task. Neuromodulation studies on healthy participants have suggested that cerebellar transcranial direct current stimulation (tDCS) is a valuable tool to modulate cognitive functions. However, so far, only a single case study has investigated whether cerebellar stimulation enhances language recovery in aphasic individuals. In a randomized, crossover, double-blind design, we explored the effect of cerebellar tDCS coupled with language treatment for verb improvement in 12 aphasic individuals. Each participant received cerebellar tDCS (20 min, 2 mA) in four experimental conditions: (1) right cathodal and (2) sham stimulation during a verb generation task and (3) right cathodal and (4) sham stimulation during a verb naming task. Each experimental condition was run in five consecutive daily sessions over 4 weeks. At the end of treatment, a significant improvement was found after cathodal stimulation only in the verb generation task. No significant differences were present for verb naming among the two conditions. We hypothesize that cerebellar tDCS is a viable tool for recovery from aphasia but only when the language task, such as verb generation, also demands the activation of nonlinguistic strategies.
Cerebellar tDCS: A Novel Approach to Augment Language Treatment Post-stroke. [2023]People with post-stroke aphasia may have some degree of chronic deficit for which current rehabilitative treatments are variably effective. Accumulating evidence suggests that transcranial direct current stimulation (tDCS) may be useful for enhancing the effects of behavioral aphasia treatment. However, it remains unclear which brain regions should be stimulated to optimize effects on language recovery. Here, we report on the therapeutic potential of right cerebellar tDCS in augmenting language recovery in SMY, who sustained bilateral MCA infarct resulting in aphasia and anarthria. We investigated the effects of 15 sessions of anodal cerebellar tDCS coupled with spelling therapy using a randomized, double-blind, sham controlled within-subject crossover trial. We also investigated changes in functional connectivity using resting state functional magnetic resonance imaging before and 2 months post-treatment. Both anodal and sham treatments resulted in improved spelling to dictation for trained and untrained words immediately after and 2 months post-treatment. However, there was greater improvement with tDCS than with sham, especially for untrained words. Further, generalization to written picture naming was only noted during tDCS but not with sham. The resting state functional connectivity data indicate that improvement in spelling was accompanied by an increase in cerebro-cerebellar network connectivity. These results highlight the therapeutic potential of right cerebellar tDCS to augment spelling therapy in an individual with large bilateral chronic strokes.