Transcranial Direct Current Stimulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether transcranial Direct Current Stimulation (tDCS) can help people with Parkinson's disease improve their thinking and movement abilities. The focus is on enhancing verbal skills and sensorimotor control, which often challenge those with Parkinson’s. Participants will receive either the real tDCS treatment or a placebo version to compare effects. Ideal candidates have Parkinson's with difficulties in verbal fluency and can communicate in English. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for Parkinson's disease.
What prior data suggests that transcranial direct current stimulation is safe for individuals with Parkinson's disease?
Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe and easy to tolerate. In one study where participants used tDCS devices at home, no harmful effects were reported, and most sessions proceeded smoothly. This suggests that the treatment is practical and accepted by users.
Some patients with Parkinson's disease who received tDCS noticed improvements in memory and hand movement, indicating potential benefits without major safety concerns. Although tDCS does not seem to help with short-term movement problems in Parkinson's disease, it remains a safe option for addressing other symptoms.
Overall, the evidence supports the safety of tDCS, making it a potentially good choice for those considering participation in clinical trials.12345Why 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 approach that directly targets brain activity. Unlike traditional medications that often focus on managing symptoms through dopamine replacement, tDCS works by applying a small electrical current to specific areas of the brain, potentially modifying neural activity and improving motor function without the side effects of drugs. Additionally, the use of a high-definition transcranial direct current stimulator allows for precise stimulation, which could lead to more targeted and effective treatment outcomes. This innovative method could complement existing therapies, providing patients with a new option that enhances their quality of life.
What evidence suggests that transcranial direct current stimulation is effective for Parkinson's disease?
Transcranial Direct Current Stimulation (tDCS) uses gentle electrical currents to stimulate specific brain areas without surgery. This trial compares the effects of active tDCS with a sham version to evaluate its effectiveness. While research is ongoing, early studies have suggested that tDCS might enhance cognitive skills such as memory and attention. For individuals with Parkinson's disease, this could improve speaking abilities and movement. Although further research is necessary, the potential for tDCS to alleviate these symptoms appears promising. Early indications show that tDCS could be a valuable tool in managing Parkinson's disease symptoms.678910
Who Is on the Research Team?
John Hart, MD
Principal Investigator
Callier Clinical Research Center, The University of Texas at Dallas
Saul A Frankford, PhD
Principal Investigator
Callier Clinical Research Center, The University of Texas at Dallas
Are You a Good Fit for This Trial?
This trial is for people aged 50 to 90 who have Parkinson's disease with problems in verbal fluency. Participants must be able to understand and sign consent forms, and speak and read English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high definition transcranial direct current stimulation (HD tDCS) targeting the pre-supplementary motor area (preSMA) to improve verbal retrieval, speech, and motor abilities.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments on phonemic fluency and speaking rate.
What Are the Treatments Tested in This Trial?
Interventions
- transcranial direct current stimulation
Trial Overview
The study tests whether high definition transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, can improve thinking, speaking, and movement abilities in people with Parkinson's disease compared to a sham (inactive) treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas at Dallas
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborator
Citations
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Protocol for evaluating the effects of tDCS and tACS on brain ...
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Transcranial Direct Current Stimulation (tDCS) and ...
In addition, some patients with Parkinson's disease (PD) experience improvement in memory and report better use of the hand after tDCS.
Research Applications
We have completed a 17-patient study under an open FDA IDE demonstrating median seizure reduction of 41% in these patients, and expect to start a pivotal study ...
tDCS at home with Starstim
Participants reported no adverse events and 97% of sessions were fully completed without interruption. feasible, safe, and well-accepted by ...
Transcranial Direct Current Stimulation on Parkinson's ...
Our results demonstrated that there was no significant effect of tDCS on short-term motor symptoms of PD, regardless of brain area, number of stimulated nominal ...
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