tDCS for Stroke

Overseen By Sharyl Samargia-Grivette

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Seizures, Neurologic injury, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to aid stroke survivors using cerebellar tDCS (transcranial direct current stimulation), which sends a small electrical current to the brain. The main goal is to determine the duration of the treatment's effects and its impact on brain activity, thinking, language, and movement. Researchers will divide participants into three groups to receive different types of stimulation or a sham (inactive) treatment. The trial seeks healthy adults who can see and hear well, read, and use a keyboard. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in stroke recovery.

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 prior data suggests that cerebellar tDCS is safe for individuals with unilateral cortical stroke?

Research has shown that cerebellar transcranial direct current stimulation (tDCS) is generally safe. This technique sends a small electrical current to the brain and has improved movement in stroke patients. The treatment is usually well-tolerated, with only mild side effects. Some individuals have experienced minor issues such as headaches, tiredness, a burning sensation under the electrodes, or dizziness. Importantly, no serious side effects have been linked to cerebellar tDCS, suggesting it is a safe option for those considering participation in a clinical trial with this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke treatments that typically rely on medications or physical therapy, cerebellar transcranial Direct Current Stimulation (tDCS) offers a novel approach by using electrical currents to stimulate the brain. Researchers are excited about this technique because it targets the cerebellum, a part of the brain crucial for motor control and coordination, potentially enhancing recovery in ways standard therapies don't. This non-invasive method is unique because it can be precisely controlled and targeted, providing a customizable treatment experience that might enhance neuroplasticity and accelerate rehabilitation.

What evidence suggests that cerebellar tDCS could be effective for stroke recovery?

Research shows that cerebellar transcranial direct current stimulation (tDCS) can help stroke patients improve movement and speech. In this trial, participants will be randomized into groups to receive either real anodal tDCS, real cathodal tDCS, or a sham treatment. Previous studies have shown that anodal tDCS on the cerebellum, combined with speech therapy, enhanced language skills. Another study found that cathodal tDCS with speech therapy improved language abilities in individuals with post-stroke speech difficulties. Additionally, tDCS has aided in the recovery of arm and hand movements, crucial for everyday tasks. These findings suggest that cerebellar tDCS may benefit stroke recovery. ^{1 4 6 7 8}

Who Is on the Research Team?

Sharyl Samargia-Grivette

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke. Participants need good vision to see a computer screen, fine motor skills to use a keyboard, and hearing to follow directions. They must be able to read and understand English fluently.

Inclusion Criteria

Participants must be able to read words and phrases

Participants must be fluent in English

Participants must have adequate vision to see a computer screen from 12-18 inches, fine motor skills to press a key on a computer keyboard, and hearing to hear directions and questions provided by the researcher

Exclusion Criteria

Pregnancy

History of documented learning disabilities and/or ADHD

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive cerebellar tDCS and are assessed for cortical excitability, cognitive, language, and motor performance at baseline, 15, 45, and 75 minutes post-tDCS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects of tDCS and safety

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cerebellar tDCS

Trial Overview The study tests how cerebellar transcranial direct current stimulation (tDCS) affects brain activity over time in stroke survivors. It measures changes immediately after tDCS and at intervals up to 75 minutes later using cognitive, language, and motor tasks.

How Is the Trial Designed?

Group I: Real cathodal tDCS group (REAL-C) Experimental Treatment 1 Intervention

Participants randomized to REAL-C

Group II: Real anodal tDCS group (REAL-A) Experimental Treatment 1 Intervention

Participants randomized to REAL-A

Group III: Sham group (SHAM) Placebo Group 1 Intervention

Participants randomized to SHAM group

Cerebellar tDCS is already approved in United States, European Union for the following indications:

Approved in United States as Cerebellar tDCS for:

• Stroke rehabilitation
• Aphasia treatment
• Motor function recovery

Approved in European Union as Cerebellar tDCS for:

• Stroke rehabilitation
• Aphasia treatment
• Motor function recovery

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a pilot study involving 12 patients with treatment-resistant depression, combining bilateral cerebellar tDCS with traditional bifrontal stimulation resulted in a 30% reduction in depressive symptoms after just 10 sessions over five days.

The study suggests that targeting the cerebellum may enhance the effectiveness of tDCS for younger patients, while the safety profile remains similar to conventional tDCS methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Bilateral Frontal and Bilateral Cerebellar Transcranial Direct Current Stimulation in Treatment-Resistant Depression-Clinical Effects and Electrical Field Modelling of a Novel Electrodes Montage. D'Urso, G., Dini, M., Bonato, M., et al.[2022]

Cerebellar transcranial direct current stimulation (tDCS) is a safe and non-invasive method that can induce lasting changes in cerebellar function, affecting both motor and non-motor skills in healthy individuals.

Preliminary evidence suggests that cerebellar tDCS may also be a promising therapeutic option for patients with cerebellar disorders, as recent modeling studies indicate that the technique effectively targets cerebellar neurons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar tDCS: how to do it. Ferrucci, R., Cortese, F., Priori, A.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Cerebellar transcranial direct current stimulation (ctDCS) shows potential in improving post-stroke language and motor dysfunction, particularly in gait, based on a systematic review of 11 studies involving 169 stroke patients.

While cathodal ctDCS stimulation led to significant improvements in verb generation tasks compared to sham treatment, the overall evidence is limited and of low quality, indicating a need for more rigorous studies with larger sample sizes to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cerebellar Transcranial Direct Current Stimulation in Patients with Stroke: a Systematic Review. Hong-Yu, L., Zhi-Jie, Z., Juan, L., et al.[2023]

The study found that individual anatomical differences, such as skin-cerebellum distance and specific angles of the posterior fossa, significantly influence the strength of electric fields generated by cerebellar transcranial direct current stimulation (tDCS), which can affect its clinical and neurophysiological outcomes.

Using different electrode configurations, the research showed that cephalic montages produced stronger electric fields in the cerebellum compared to extracephalic montages, which resulted in a more focused field, suggesting that electrode placement is crucial for optimizing tDCS effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interindividual differences in posterior fossa morphometry affect cerebellar tDCS-induced electric field strength. Maas, RPPWM., Faber, J., van de Warrenburg, BPC., et al.[2023]

A two-week treatment with cerebellar anodal transcranial direct current stimulation (tDCS) significantly improved symptoms in patients with neurodegenerative cerebellar ataxia, as shown by better performance on various clinical assessments.

The treatment not only enhanced motor performance but also restored normal cerebellar brain inhibition pathways, suggesting that cerebellar tDCS could be a promising therapeutic option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term clinical and neurophysiological effects of cerebellar transcranial direct current stimulation in patients with neurodegenerative ataxia. Benussi, A., Dell'Era, V., Cotelli, MS., et al.[2022]

In a study involving 15 chronic stroke patients, transcranial direct current stimulation (tDCS) applied to the contra-lesional cerebellum significantly improved standing balance performance, as indicated by a decrease in the composite score during tandem standing tasks.

The results suggest that contra-lesional cerebellar tDCS may be a promising adjunct therapy for enhancing balance in stroke rehabilitation, although further research is needed to optimize treatment parameters and understand the relationship between balance improvements and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Effects of Cerebellar tDCS on Standing Balance Performance in Patients with Chronic Stroke and Healthy Age-Matched Elderly. Zandvliet, SB., Meskers, CGM., Kwakkel, G., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6724454/

The effect of cerebellar transcranial direct current ... We hypothesize that: patients receiving VR-PFT+cb_tDCS will show a clinically meaningful improvement of 6 points or more on the Berg Balance Scale (BBS) at 15 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10060824/

Effects of cerebellar transcranial direct current stimulation on ... This study aimed to explore whether cerebellar transcranial direct current stimulation (tDCS) therapy could promote the recovery of upper limb motor function

3. nature.com nature.com/articles/s41598-025-90927-y

Cerebellar transcranial direct current stimulation improves ... This study investigated the efficacy of anodal tDCS over the right cerebellum paired with speech and language therapy in enhancing language functions and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2467981X25000563

Efficacy of cerebellar cathodal transcranial direct current ... Cerebellar cathodal tDCS combined with speech therapy improved language scores in post-stroke aphasia. •. fNIRS showed decreased right and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025001534

Effects of cerebellar repetitive transcranial magnetic ... Existing evidence suggests that cerebellar rTMS holds promise in mitigating post-stroke swallowing dysfunction and motor dysfunction.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37006504/

Effects of cerebellar transcranial direct current stimulation ... Conclusion: Cerebellar tDCS can be used as an effective and safe treatment to promote recovery of upper limb motor function in stroke patients.

7. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.30043

Cerebellar Transcranial Direct Current Stimulation in the ... Cerebellar tDCS was well tolerated and no serious adverse events related to the intervention occurred. No significant tDCS effect was found on ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923010814

Cerebellar Transcranial Direct Current Stimulation in ... In general, cerebellar tDCS was safe and well-tolerated. Mild headache, transient tiredness, a burning feeling underneath the electrodes, and dizziness for ...