Transcranial Direct Current Stimulation for Parkinson's Disease
Recruiting in Palo Alto (17 mi)
Overseen byKelly Mills, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Benzodiazepines, Anticonvulsants, others
Disqualifiers: Bipolar, PTSD, Psychotic disorders, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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 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.
12345What 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.
26789Is 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.
123410Eligibility Criteria
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
+2 more
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)
+9 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA
Group II: Sham tDCSPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins Hospital / Johns Hopkins UniversityBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
References
Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. [2019]Recent research has highlighted the potential of transcranial direct current stimulation (tDCS) to complement rehabilitation effects in the elderly and in patients with neurological diseases, including Parkinson's disease (PD). TDCS can modulate cortical excitability and enhance neurophysiological mechanisms that compensate for impaired learning in PD. The objective of this systematic review is to provide an overview of the effects of tDCS on neurophysiological and behavioral outcome measures in PD patients, both as a stand-alone and as an adjunctive therapy. We systematically reviewed the literature published throughout the last 10 years. Ten studies were included, most of which were sham controlled. Results confirmed that tDCS applied to the motor cortex had significant results on motor function and to a lesser extent on cognitive tests. However, the physiological mechanism underlying the long-term effects of tDCS on cortical excitability in the PD brain are still unclear and need to be clarified in order to apply this technique optimally to a wider population in the different disease stages and with different medication profiles.
The effect of single and repeated tDCS sessions on motor symptoms in Parkinson's disease: a systematic review. [2020]to update understanding of the effectiveness of transcranial direct current stimulation (tDCS) on motor dysfunction in Parkinson's disease, since the last review was published in 2016.
Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease. [2019]Transcranial direct current stimulation (tDCS) is a non-invasive technique for inducing prolonged functional changes in the human cerebral cortex. This simple and safe neurostimulation technique for modulating motor functions in Parkinson's disease could extend treatment option for patients with movement disorders. We assessed whether tDCS applied daily over the cerebellum (cerebellar tDCS) and motor cortex (M1-tDCS) improves motor and cognitive symptoms and levodopa-induced dyskinesias in patients with Parkinson's disease (PD). Nine patients (aged 60-85 years; four women; Hoehn & Yahr scale score 2-3) diagnosed as having idiopathic PD were recruited. To evaluate how tDCS (cerebellar tDCS or M1-tDCS) affects motor and cognitive function in PD, we delivered bilateral anodal (2 mA, 20 min, five consecutive days) and sham tDCS, in random order, in three separate experimental sessions held at least 1 month apart. In each session, as outcome variables, patients underwent the Unified Parkinson's Disease Rating Scale (UPDRS III and IV) and cognitive testing before treatment (baseline), when treatment ended on day 5 (T1), 1 week later (T2), and then 4 weeks later (T3), at the same time each day. After patients received anodal cerebellar tDCS and M1-tDCS for five days, the UPDRS IV (dyskinesias section) improved (p 0.05). Despite the small sample size, our preliminary results show that anodal tDCS applied for five consecutive days over the motor cortical areas and cerebellum improves parkinsonian patients' levodopa-induced dyskinesias.
Effectiveness of acute transcranial direct current stimulation on non-motor and motor symptoms in Parkinson's disease. [2019]Transcranial direct current stimulation (tDCS) is an appropriate treatment for Parkinson's disease (PD). It offers promising results and is known to improve symptoms. Nevertheless, consistent parameters need to be established for research purposes.
tDCS application for postural control in Parkinson's disease: Effects are associated with baseline characteristics. [2022]Transcranial direct current stimulation (tDCS) improves postural response to perturbation in patients with Parkinson's disease (PwPD). However, the influence of baseline characteristics such as clinical/cognitive and postural performance on the response to tDCS remains unclear.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson's disease. [2020]Transcranial direct current stimulation (tDCS) is a modality of non-invasive brain stimulation involving the application of low amplitude direct current via surface electrodes on the scalp. tDCS has been studied in healthy populations and in multiple brain disorders and has the potential to be a treatment for several neuropsychiatric conditions by virtue of its capability of influencing cognitive, motor and behavioral processes. tDCS is a generally safe technique when performed within standardized protocols in research or clinical settings. Furthermore, tDCS portability, high acceptability and user-friendly interface makes it highly appealing for telemedicine practices. The term "telemedicine" refers to the procedures, educational strategies, and care services that are remotely administered by means of different communication technologies, with the final goal of increasing access to care for individuals and for improving public health. The use of telemedicine combined with tDCS protocols is increasing, although the safety of this approach in different clinical settings awaits further assessment. While "do-it-yourself" tDCS should be discouraged due to the unknown risk of adverse events, the implementation of tele-monitored tDCS (tele-tDCS) within standardized frameworks ensuring safety, tolerability, and reproducibility may allow this technology to reach larger clinical populations and bypass some of the common barriers preventing access to health services and clinical trials. This review will discuss the current evidence supporting the feasibility of tele-tDCS paradigms and their therapeutic potential, with particular emphasis on the implications for patients with Parkinson's disease.
Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]Transcranial direct current stimulation (tDCS) has strong potential for outpatient clinical use, but feasibility and safety of tDCS has only been evaluated in laboratory and inpatient clinical settings. The objective of this study was to assess feasibility and safety of tDCS for stroke in an outpatient clinical setting. Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions. Feasibility was assessed with screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS. Acute changes in fatigue and self-reported function and pre-post changes in fatigue were also assessed. Safety was assessed as adverse events and side effects. In total, 85 individuals were screened, and 10 were enrolled. Most exclusions were unrelated to clinical feasibility. In total, 3 participants withdrew, so 7 participants completed 2 sessions/week for 5-6 weeks with 100% adherence. In total, 71% reported positive impressions of tDCS. tDCS setup decreased to 5-7 min at end of study. There was one adverse event unrelated to tDCS. Mild to moderate side effects (tingling, itching, pinching, and fatigue) were experienced. In total, 86% of participants recounted benefits of tDCS. There were acute improvements in function and energy. Results support the feasibility and safety of tDCS in an outpatient clinical setting.
Bilateral anodal transcranial direct current stimulation effect on balance and fearing of fall in patient with Parkinson's disease. [2018]A number of studies have examined the therapeutic effects of transcranial direct current stimulation (tDCS) stimulation in patients with Parkinson's disease (PD) using unilateral anodal stimulation applied either on the left or right brain hemisphere. However, PD involves the dysfunctions of both brain hemispheres.