Transcranial Direct Current 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, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcranial direct current stimulation (tDCS) to determine if it can improve movement and reduce fatigue in people with Parkinson's disease. Researchers believe that sending small electrical currents to a specific part of the brain might enhance motor function and lessen fatigue. The trial includes two groups: one will receive the real treatment, and the other will receive a sham treatment. Individuals with Parkinson's disease who experience symptoms like tremors or stiffness might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

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

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 transcranial direct current stimulation is safe for Parkinson's disease patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In one study, 33.3% of participants experienced minor side effects during their sessions, with tingling at the contact site being the most common. These effects were mild and brief.

Although tDCS has not been proven to improve movement or balance in people with Parkinson's disease, it remains safe. Its use in other conditions suggests it is well-tolerated. Prospective participants should consult a healthcare provider for personal advice before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Parkinson’s disease, which often involve medications like levodopa and dopamine agonists, transcranial direct current stimulation (tDCS) offers a non-invasive approach that targets brain activity directly. Researchers are excited about tDCS because it uses mild electrical currents to potentially enhance neural connectivity and improve motor function. This method is unique because it may provide benefits without the side effects commonly associated with long-term medication use. Moreover, tDCS can be administered quickly and may show results in just a few days, offering a promising alternative or complement to existing therapies.

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

Research has shown that transcranial direct current stimulation (tDCS) can aid people with Parkinson's disease (PD) by enhancing movement and reducing fatigue. Some studies found that tDCS improves walking and balance, common issues for those with PD. It may also enhance cognitive skills, making daily tasks easier. Although results can vary, these findings suggest that tDCS might be a useful option for managing PD symptoms. In this trial, participants in the experimental group will receive 2mA of anodal tDCS for 20 minutes daily over 5 consecutive days, while the sham group will receive brief stimulation during each session. ^{1 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 individuals with Parkinson's Disease who experience motor function difficulties and fatigue. Participants must be eligible based on specific criteria set by the researchers, which are not detailed here.

Inclusion Criteria

Must be able to consent

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

Exclusion Criteria

I have been diagnosed with congestive heart failure.

Patients with dementia (MOCA < 21)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 2mA of anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests if a non-invasive brain stimulation technique called anodal transcranial direct current stimulation (atDCS) can improve movement and reduce tiredness in Parkinson's patients compared to no treatment.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

The experimental group will receive 2mA of anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 consecutive 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.

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

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 demonstrated hypoalgesic effects on Parkinson's disease (PD)‐related pain applied in the On state but not in the Off state.

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. 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.

7. 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 ...

8. 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 ...

9. 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 ...