Electrical Brain Stimulation for Parkinson's Disease

(tDCS Trial)

Overseen By Jessica Keller, B.S.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Sanford Health

Disqualifiers: Dementia, Psychosis, Stroke, Epilepsy, 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: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special type of electrical brain stimulation, known as Transcranial Direct Current Stimulation (tDCS), can help people with Parkinson's disease think more clearly and feel less mentally tired. Participants will receive either the actual treatment, involving a mild electrical current to the brain, or a placebo version for comparison. The trial targets individuals with Parkinson's who experience symptoms like tremors or stiffness and struggle with mild cognitive issues.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance cognitive function in Parkinson's patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using deep brain stimulation (DBS) for Parkinson's Disease, you cannot participate in the trial.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, it excludes those using deep brain stimulation for Parkinson's treatment.

What prior data suggests that this method is safe for Parkinson's Disease patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally well-tolerated. In one study, about 33% of participants experienced side effects, mostly tingling sensations under the electrodes. While some might feel mild discomfort, serious side effects are rare.

tDCS has also been studied for its potential to aid thinking and memory in people with Parkinson’s disease. Although it doesn't significantly improve movement or balance on its own, it is considered safe for most individuals.

Overall, tDCS appears to be a low-risk treatment option that could address cognitive issues related to Parkinson’s disease without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for Parkinson's disease because it offers a non-invasive way to potentially improve symptoms. Unlike standard treatments like Levodopa or deep brain stimulation, which involve medication or surgery, tDCS uses mild electrical currents to stimulate specific brain areas. This approach could lead to fewer side effects and be more accessible to patients who might not be candidates for surgical options. Additionally, tDCS could provide quicker symptom relief, as it is administered daily over just five days.

What evidence suggests that transcranial direct current stimulation is effective for improving cognitive function in Parkinson's disease?

Research has shown that transcranial direct current stimulation (tDCS), a treatment that participants in this trial may receive, can improve thinking skills in people with Parkinson's disease. Studies have found that tDCS can enhance memory and attention. Some research also suggests it might aid balance and walking. These findings indicate that tDCS could reduce mental fatigue and ease daily life for those with Parkinson's. However, not all studies agree, so results can vary. Participants in the sham group of this trial will receive a placebo version of tDCS, involving no active stimulation after the initial ramp-up period. ^{3 6 7 8 9}

Who Is on the Research Team?

Jau-Shin Lou, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

This trial is for Parkinson's patients with mild cognitive impairment (MOCA scores between 21 and 26) who exhibit at least two of the main symptoms: tremor, rigidity, bradykinesia, or postural instability. Participants must be able to give consent and speak English fluently. Those with severe lung, heart, kidney diseases, dementia, deep brain stimulation treatment for PD, psychosis, multiple sclerosis, stroke history or epilepsy cannot join.

Inclusion Criteria

Meets criteria for MCI (21 ≤ MOCA scores ≤ 26)

Must be able to consent

I have Parkinson's disease with symptoms like tremor or stiffness.

Exclusion Criteria

Patients with dementia (MOCA < 21)

I am receiving or have received DBS for Parkinson's disease.

I have been diagnosed with epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for cognitive function and fatigue improvements after treatment

2 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sham (for Transcranial Direct Current Stimulation)
• Transcranial Direct Current Stimulation

Trial Overview The study tests if a non-invasive brain stimulation technique called anodal transcranial direct current stimulation (atDCS), applied to the left dorsolateral prefrontal cortex can improve cognition and reduce fatigue in Parkinson's patients compared to a sham (fake) procedure.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

The experimental group will receive 2 milliamps of anodal transcranial direct current stimulation for 20 minutes daily for 5 days.

Group II: Sham group Placebo Group 1 Intervention

The sham group will be connected to the anodal transcranial direct current stimulation device daily for 5 days. During the 20 minute sessions, the participant will only receive stimulation for a 30-second ramp up period, at which point the stimulation will be discontinued for the remainder of the time.

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

Published Research Related to This Trial

In a study involving nine patients with Parkinson's disease, five consecutive days of anodal transcranial direct current stimulation (tDCS) over the motor cortex and cerebellum significantly improved levodopa-induced dyskinesias, as measured by the UPDRS IV scale (p < 0.001).

While the study showed promising results for reducing dyskinesias, other motor and cognitive symptoms did not show significant changes with either tDCS or sham treatment, indicating that tDCS may specifically target dyskinesias in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease. Ferrucci, R., Cortese, F., Bianchi, M., et al.[2019]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Transcranial direct current stimulation (tDCS) shows promise in improving motor dysfunction in Parkinson's disease, with significant improvements noted in mobility, balance, and gait velocity across 29 studies involving a total of 550 patients.

Multi-target stimulation with tDCS was more effective than mono-target stimulation, indicating that optimizing stimulation protocols could enhance therapeutic outcomes, although fully optimized protocols are still not established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of single and repeated tDCS sessions on motor symptoms in Parkinson's disease: a systematic review. Orrù, G., Baroni, M., Cesari, V., et al.[2020]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Anodal transcranial direct current stimulation (tDCS) of the primary motor cortex (M1) significantly improved motor function in Parkinson's disease patients, as measured by the Unified Parkinson's Disease Rating Scale and simple reaction time, compared to sham stimulation.

This study also found that anodal stimulation increased motor-evoked potential (MEP) amplitude and area, suggesting a mechanism by which tDCS enhances motor function, while cathodal stimulation had the opposite effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Fregni, F., Boggio, PS., Santos, MC., et al.[2022]

In a study of 24 patients with Parkinson's disease, those with poorer baseline postural control showed greater improvements in postural responses after receiving active transcranial direct current stimulation (tDCS), indicating that tDCS can be particularly beneficial for individuals with more severe postural issues.

The study found no significant correlations between clinical or cognitive characteristics and the effectiveness of tDCS, suggesting that the baseline level of postural control is a more critical factor in determining the response to this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS application for postural control in Parkinson's disease: Effects are associated with baseline characteristics. Beretta, VS., Orcioli-Silva, D., Conceição, NR., et al.[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]

A single session of transcranial direct current stimulation (tDCS) applied to the dorsolateral prefrontal cortex (DLPFC) showed significant improvements in cognitive performance, particularly in the Verbal Fluency test and reaction times on the Stroop test, in individuals with Parkinson's disease.

The study involved 20 participants in a double-blind, randomized, sham-controlled design, indicating that real tDCS can enhance cognitive function in PD patients, while sham stimulation did not yield the same benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of acute transcranial direct current stimulation on non-motor and motor symptoms in Parkinson's disease. Bueno, MEB., do Nascimento Neto, LI., Terra, MB., et al.[2019]

Transcranial direct current stimulation (tDCS) is generally well-tolerated in people with Parkinson's disease, but the unique sensory effects of the disease may influence how tolerability and blinding are reported compared to other groups.

The review highlighted a lack of quantitative data on tDCS tolerability and blinding in Parkinson's patients, suggesting that future studies should standardize reporting practices to better assess the true effects of tDCS and account for potential placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Blinding of Transcranial Direct Current Stimulation in People with Parkinson's Disease: A Critical Review. Workman, CD., Fietsam, AC., Rudroff, T.[2020]

Citations

1. nature.com nature.com/articles/s41531-024-00821-z

Transcranial direct current stimulation for Parkinson's disease One study (33%) found significant improvements after stimulating the sensorimotor cortex, whereas the other two studies (66%) detected no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12491758/

Transcranial Direct Current Stimulation in Parkinson's Disease ... TDCS has been shown to relieve pain and improve psychophysical pain measures in chronic pain populations [15, 16]. Previous work has ...

3. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2025.1495492/full

Efficacy of transcranial direct current stimulation on ... Conclusion: tDCS demonstrated substantial efficacy in enhancing overall cognition in patients with PD. The efficacy of tDCS was obvious in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40046783/

Efficacy of transcranial direct current stimulation on ... Conclusion: tDCS demonstrated substantial efficacy in enhancing overall cognition in patients with PD. The efficacy of tDCS was obvious in ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01311-2

Effects of transcranial direct current stimulation alone and in ... Our results indicated that tDCS is significantly associated with gait and balance improvements among individuals with PD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880240/

Efficacy of transcranial direct current stimulation on ... The improvement of overall cognition in patients with Parkinson's disease with tDCS was the primary outcome indicator. The improvement of ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210533615300125?via%3Dihub

Transcranial direct current stimulation as treatment for ... This brief review focuses on available data regarding the effects of tDCS on motor ability and cognition in people with movement disorders. Findings indicate ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.794784/full

Transcranial Direct Current Stimulation on Parkinson's ... There was no significant tDCS alone short-term effect on motor function, balance, gait, dyskinesias or motor fluctuations in Parkinson's disease.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2590109523000447

Feasibility and Safety of Sequential Transcranial ... Together, 2 out of 6 (33.3%) participants reported some type of side effects across their stimulation sessions. Sensations under electrodes were reported in ...