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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) will induce long-lasting effects in improving cognitive function and reducing cognitive fatigue and fatigability in PD 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 data supports the idea that Electrical Brain Stimulation for Parkinson's Disease is an effective treatment?

The available research shows that Electrical Brain Stimulation, specifically transcranial direct current stimulation (tDCS), can improve symptoms in people with Parkinson's Disease. For example, one study found that tDCS improved postural control, which is important for balance and movement. Another study showed that tDCS reduced involuntary movements caused by medication in Parkinson's patients. These findings suggest that tDCS can help manage both motor and non-motor symptoms of Parkinson's Disease, making it a promising treatment option. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for Parkinson's disease?

Research shows that transcranial direct current stimulation (tDCS) can improve motor and cognitive symptoms in Parkinson's disease, including reducing levodopa-induced dyskinesias (involuntary movements caused by medication). It also helps with postural control, although individual responses may vary based on baseline characteristics. ^{1 2 3 4 5}

What safety data exists for electrical brain stimulation in Parkinson's treatment?

The safety of transcranial direct current stimulation (tDCS) has been extensively reviewed. A 2016 evidence-based update found no reports of serious adverse effects or irreversible injury across over 33,200 sessions and 1,000 subjects, including vulnerable populations. Conventional tDCS protocols (≤40 min, ≤4 mA, ≤7.2 Coulombs) are considered safe. Other reviews confirm that adverse events are low and transient, with no severe complications reported at intensities of 4 mA or less for up to 60 minutes per day. Animal studies suggest the electrical dose used in tDCS is significantly below levels that could cause brain injury. ^{1 6 7 8 9}

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

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans, with no serious adverse effects reported in over 33,200 sessions across various populations, including potentially vulnerable groups. The amount of electricity used in tDCS is much lower than levels that could cause brain injury, ensuring safety when used at standard intensities and durations. ^{1 6 7 8 9}

Is Transcranial Direct Current Stimulation (tDCS) a promising treatment for Parkinson's Disease?

Yes, Transcranial Direct Current Stimulation (tDCS) is a promising treatment for Parkinson's Disease. It has been shown to improve motor function, reduce movement problems caused by medication, and enhance postural control in patients. ^{1 2 3 4 10}

How does transcranial direct current stimulation (tDCS) differ from other treatments for Parkinson's disease?

Transcranial direct current stimulation (tDCS) is a non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, which can improve motor and cognitive symptoms in Parkinson's disease. Unlike deep brain stimulation, which requires surgery, tDCS is applied externally and is considered simple and safe, offering a potential alternative for patients with movement disorders. ^{1 2 3 4 10}

Research Team

Jau-Shin Lou, MD

Principal Investigator

Sanford Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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) 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]

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 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 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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The effect of single and repeated tDCS sessions on motor symptoms in Parkinson's disease: a systematic review. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of acute transcranial direct current stimulation on non-motor and motor symptoms in Parkinson's disease. [2019]

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

Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

tDCS application for postural control in Parkinson's disease: Effects are associated with baseline characteristics. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Tolerability and Blinding of Transcranial Direct Current Stimulation in People with Parkinson's Disease: A Critical Review. [2020]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

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

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

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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

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

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

Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. [2022]