Transcranial Direct Current Stimulation for Parkinson's Disease

Overseen By Kelly Mills, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Benzodiazepines, Anticonvulsants, others

Disqualifiers: Bipolar, PTSD, Psychotic disorders, 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: 10

Duration: 2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.

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

Yes, you may need to stop taking certain medications like benzodiazepines, anticonvulsants, dextromethorphan, and pseudoephedrine, as they can affect the treatment.

What safety data exists for Transcranial Direct Current Stimulation (tDCS)?

The safety of tDCS has been extensively studied, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations. Adverse events are generally low and transient. tDCS is considered safe when performed within standardized protocols, though caution is advised against 'do-it-yourself' applications. Mild side effects like tingling and itching have been reported, but overall, tDCS is deemed feasible and safe in both clinical and outpatient settings. ^{1 2 3 4 5}

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

Yes, Transcranial Direct Current Stimulation (tDCS) is a promising treatment for Parkinson's Disease. It has shown potential in improving motor and non-motor symptoms, enhancing balance, and reducing movement issues caused by medication. It can also support rehabilitation and improve learning in patients. ^{1 6 7 8 9}

What data supports the idea that Transcranial Direct Current Stimulation for Parkinson's Disease is an effective treatment?

The available research shows that Transcranial Direct Current Stimulation (tDCS) can improve symptoms in Parkinson's Disease. One study found that tDCS applied over the motor cortex and cerebellum for five days improved movement issues caused by medication. Another study highlighted that tDCS helps with balance and posture in patients. Overall, tDCS shows promise in enhancing motor functions and could be a useful addition to existing treatments for Parkinson's Disease. ^{1 6 8 9 10}

Who Is on the Research Team?

Kelly Mills, M.D.

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-95 with Parkinson's disease who experience depressive or neuropsychiatric symptoms. They must understand the study, speak English, and not have brain diseases, skull defects, metal implants, certain psychiatric diagnoses, recent substance abuse or suicidal attempts.

Inclusion Criteria

Meeting Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease

I have severe depression or mental health issues.

Able to provide written informed consent obtained in the English language

Exclusion Criteria

I am not pregnant nor planning to become pregnant during the study.

I have been diagnosed with Bipolar, PTSD, Psychotic Disorder, or another non-unipolar depressive disorder in the last 6 months.

Scoring less than 22 on the Montreal Cognitive Assessment (MoCA)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham transcranial direct current stimulation (tDCS) for 30 minutes over 10 treatment sessions

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests if transcranial direct current stimulation (tDCS) can help with depression and cognitive issues in Parkinson's patients. Participants will be randomly assigned to receive either real tDCS or a sham treatment over ten sessions lasting 30 minutes each.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA

Group II: Sham tDCS Placebo Group 1 Intervention

Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA

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?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) has shown significant improvements in motor function for patients with Parkinson's disease (PD), based on a systematic review of 10 studies conducted over the last decade.

While tDCS appears to enhance neurophysiological mechanisms in the PD brain, the exact physiological processes behind its long-term effects on cortical excitability remain unclear, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Broeder, S., Nackaerts, E., Heremans, E., et al.[2019]

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]

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]

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 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 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) is a safe and non-invasive brain stimulation technique that can influence cognitive and behavioral processes, making it a potential treatment for various neuropsychiatric conditions.

The combination of tDCS with telemedicine (tele-tDCS) could enhance access to treatment for patients, particularly those with Parkinson's disease, although further research is needed to ensure safety in different clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson's disease. Cucca, A., Sharma, K., Agarwal, S., et al.[2020]

Transcranial direct current stimulation (tDCS) was found to be feasible and safe for use in outpatient therapy for stroke patients, with 100% adherence among the 7 participants who completed the study over 5-6 weeks.

Most participants (71%) reported positive impressions of tDCS, experiencing acute improvements in function and energy, with only one adverse event unrelated to the treatment and mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Cleland, BT., Galick, M., Huckstep, A., et al.[2020]

Bilateral anodal transcranial direct current stimulation (tDCS) significantly improved balance and reduced fear of falling in 18 patients with Parkinson's disease after 10 sessions over 2 weeks, as measured by the Berg Balance Scale and Falls Efficacy Scale-International.

The study demonstrated that bilateral tDCS is a safe and effective rehabilitation method for addressing balance issues in Parkinson's patients, with statistically significant improvements observed in balance and walking tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral anodal transcranial direct current stimulation effect on balance and fearing of fall in patient with Parkinson's disease. Hadoush, H., Al-Jarrah, M., Khalil, H., et al.[2018]

Citations

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

Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. [2019]

2. 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]

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

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

4. Ireland pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

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

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson's disease. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Bilateral anodal transcranial direct current stimulation effect on balance and fearing of fall in patient with Parkinson's disease. [2018]