Transcranial Direct Current Stimulation for Parkinson's Disease

(Home-PD-tDCS Trial)

Overseen By Leila Montaser Kouhsari, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Depression, Cranial implants, Pacemaker, Epilepsy, others

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

Compensation: Varies

Number of Visits: 3

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether home-based transcranial direct current stimulation (tDCS) is safe and practical for people aged 40 to 70 years with Parkinson's Disease. The study aims to find out if participants can use the tDCS device at home without serious side effects and whether it is easy for them to use on their own. Participants will first attend an in-person visit to learn how to use the tDCS device. They will then use the device at home once a day for 20 minutes over seven consecutive days. Video calls on days 2 and 3 will provide support and supervision. After each session, participants will complete brief online questionnaires about any side effects and how easy the device was to use. The study will also check if using tDCS at home improves motor symptoms in Parkinson's Disease by using a standard movement assessment.

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 is best to discuss this with the trial coordinators or your doctor.

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

Research shows that tDCS is generally safe for humans, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various populations, including potentially vulnerable groups like children and the elderly. ^{1 2 3 4 5}

How does the treatment tDCS differ from other treatments for Parkinson's disease?

Transcranial direct current stimulation (tDCS) is unique because it is a non-invasive technique that uses electrical currents to stimulate specific areas of the brain, potentially improving motor and cognitive symptoms in Parkinson's disease. Unlike traditional drug treatments, tDCS does not involve medication and can be applied directly to the motor cortex and cerebellum to reduce symptoms like levodopa-induced dyskinesias. ^{3 6 7 8 9}

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

Research shows that transcranial direct current stimulation (tDCS) can improve motor function and postural control in people with Parkinson's disease. It works by modulating brain activity, which may help with movement and learning difficulties associated with the condition. ^{3 6 8 10 11}

Who Is on the Research Team?

Michael D Fox, MD, PhD

Principal Investigator

Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital, Boston, MA

Are You a Good Fit for This Trial?

This trial is for people aged 40 to 70 with Parkinson's Disease who can use a tDCS device at home. They should be able to attend an in-person training, handle daily sessions for a week, and complete online questionnaires. Specific eligibility criteria were not provided.

Inclusion Criteria

I am between 40 and 70 years old with Parkinson's disease and agree to participate.

Patients should have access to a computer system for video calls and completing the questionnaires, and they must be able to use it

Exclusion Criteria

Substance abuse

I have had a stroke.

Cranial metal implants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training

Participants attend an in-person visit to learn how to use the tDCS device

1 day

1 visit (in-person)

Home-based tDCS Treatment

Participants use the tDCS device at home once a day for 20 minutes over seven consecutive days with video call support on days 2 and 3

7 days

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests the safety and feasibility of using transcranial direct current stimulation (tDCS) at home by patients with Parkinson's Disease. It involves daily 20-minute sessions over one week, with remote supervision on days two and three.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Subjects receiving active tDCS

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

Bilateral anodal transcranial direct current stimulation (tDCS) is a safe treatment that significantly improves motor functions in patients with Parkinson's disease, as indicated by a decrease in the MDS-UPDRS-III total score after ten sessions.

The treatment also led to a significant increase in BDNF serum levels, although this increase did not correlate with the observed improvements in motor function, suggesting that other mechanisms may be involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dopamine, BDNF and motor function postbilateral anodal transcranial direct current stimulation in Parkinson's disease. Hadoush, H., Banihani, SA., Khalil, H., 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 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]

Transcranial direct current stimulation (tDCS) over the left sensorimotor area significantly improved motor symptoms in ten patients with Parkinson's disease, indicating its potential as a therapeutic intervention.

Neurophysiological analysis revealed that tDCS enhanced cortical activity and synchronization specifically during fine motor tasks, suggesting that the effects of tDCS are task-dependent and may help in motor integration for PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal tDCS modulates cortical activity and synchronization in Parkinson's disease depending on motor processing. Schoellmann, A., Scholten, M., Wasserka, B., 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]

Transcranial direct current stimulation (tDCS) is a safe intervention for pediatric motor disorders, with no significant difference in dropout rates between active and sham groups, and only mild adverse effects reported, such as tingling and discomfort.

In children with cerebral palsy, tDCS significantly improved gait velocity, stride length, and cadence, suggesting it may enhance certain motor functions, although its effectiveness on balance and upper extremity function remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. Saleem, GT., Crasta, JE., Slomine, BS., et al.[2021]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Dopamine, BDNF and motor function postbilateral anodal transcranial direct current stimulation in Parkinson's disease. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Anodal tDCS modulates cortical activity and synchronization in Parkinson's disease depending on motor processing. [2020]

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

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. 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]

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

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

11. Ireland pubmed.ncbi.nlm.nih.gov

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