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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population. Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity. The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point. Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface.

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 Cerebellar tDCS for stroke?

Research shows that cerebellar tDCS can improve standing balance in stroke patients, suggesting it may help with motor recovery. Additionally, it has shown promise in improving symptoms in other conditions like depression and cerebellar ataxias, indicating its potential as a therapeutic option. ^{1 2 3 4 5}

Is cerebellar transcranial direct current stimulation (tDCS) safe for humans?

Cerebellar tDCS is considered a simple and safe technique, with no reports of serious adverse effects or irreversible injury in human trials, even among potentially vulnerable populations like those with stroke. ^{1 4 5 6 7}

How does cerebellar tDCS treatment for stroke differ from other treatments?

Cerebellar tDCS is unique because it is a non-invasive technique that uses electrical currents to stimulate the cerebellum, which can help improve motor functions and balance in stroke patients. Unlike traditional therapies, it specifically targets the cerebellum to modulate its activity, potentially enhancing rehabilitation outcomes. ^{1 2 4 5 6}

Research Team

Sharyl Samargia-Grivette

Principal Investigator

University of Minnesota

Eligibility Criteria

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

I have a history of seizures.

History of documented learning disabilities and/or ADHD

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cerebellar tDCS: how to do it. [2022]

2. United States 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. [2018]

3. Switzerland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long term clinical and neurophysiological effects of cerebellar transcranial direct current stimulation in patients with neurodegenerative ataxia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Cerebellar Transcranial Direct Current Stimulation in Patients with Stroke: a Systematic Review. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Interindividual differences in posterior fossa morphometry affect cerebellar tDCS-induced electric field strength. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]