Trial Summary
What is the purpose of this trial?This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.
Is the treatment using a non-invasive neuromodulation device promising for Parkinson's disease?Yes, the treatment using a non-invasive neuromodulation device shows promise for Parkinson's disease. It is a portable and cost-effective method that can help improve symptoms like depression and cognitive issues. Studies suggest it could be a useful tool for treating movement disorders, including Parkinson's disease.2581011
What data supports the idea that Inner Ear Stimulation for Parkinson's Disease is an effective treatment?The available research shows that Inner Ear Stimulation, specifically using techniques like transcranial direct current stimulation (tDCS), has shown some promise in treating Parkinson's Disease. Studies have indicated that tDCS can help improve nonmotor symptoms such as depression and cognitive issues in Parkinson's patients. While the results are preliminary, they suggest that this treatment could be a useful addition to current rehabilitation methods, which often have limited effectiveness. However, more research is needed to confirm these findings and to explore the full potential of this treatment.345910
What safety data is available for inner ear stimulation in Parkinson's treatment?The safety data for inner ear stimulation, which may be evaluated under various names like tDCS, tACS, and others, indicates that these non-invasive neuromodulation techniques are generally regarded as safe and well-tolerated. A pilot study on a novel HD transcranial burst electrostimulation device showed no severe adverse events, with only slight skin redness observed. Additionally, the output characteristics of tDCS, tACS, and tPCS are well below those of most FDA-cleared devices, suggesting low risk when responsibly manufactured and marketed. However, more specific safety data for Parkinson's treatment would require further clinical trials.167911
Do I need to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Eligibility Criteria
This trial is for people who have had Parkinson's Disease for at least 5 years and are experiencing balance issues. They should be in the Hoehn & Yahr stages 1.5-4, which measures disease progression. Those with other conditions that mimic PD or ear problems like Meniere's disease cannot join, nor can those with brain lesions on MRI, metal implants that affect MRI safety, severe claustrophobia, exposure to too much radiation recently, pregnant or breastfeeding women, or active mood disorders.Inclusion Criteria
I have had Parkinson's disease for 5+ years or my condition is moderately severe.
Exclusion Criteria
I currently have an ear infection or a perforated eardrum.
I have a stable mood and do not suffer from severe anxiety.
I have a history of Meniere's disease or recent balance issues.
Treatment Details
The study is testing two patterns of non-invasive neuromodulation devices designed to stimulate the inner ear to see if they can improve balance and gait in Parkinson's patients. Participants will undergo clinical tests and brain imaging alongside using these treatment devices.
2Treatment groups
Experimental Treatment
Group I: Investigational Treatment 2Experimental Treatment1 Intervention
Investigational treatment stimulation pattern 2
Group II: Investigational Treatment 1Experimental Treatment1 Intervention
Investigational treatment stimulation pattern 1
Non-invasive neuromodulation device is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Non-invasive neuromodulation device for:
- Parkinson's disease symptoms including gait disturbances, imbalance, and motor symptoms
🇪🇺 Approved in European Union as Non-invasive neuromodulation device for:
- Parkinson's disease symptoms including gait disturbances, imbalance, and motor symptoms
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who is running the clinical trial?
University of MichiganLead Sponsor
US Department of Veterans AffairsCollaborator
References
Safety considerations for deep brain stimulation: review and analysis. [2007]Deep brain stimulation has emerged rapidly as an effective therapy for movement disorders. Deep brain stimulation includes an implanted brain electrode and a pacemaker-like implanted pulse generator. The clinical application of deep brain stimulation proceeded in the absence of clear understandings of its mechanisms of action or extensive preclinical studies of safety and efficacy. Post mortem studies suggest that there is a loss of neurons in proximity to the active electrode, but the resulting lesions are not sufficient to treat the disorder and efficacy requires continued stimulation. Overall complication rates can exceed 25%, and permanent neurologic sequelae result in 4-6% of cases. As the application of deep brain stimulation expands, it is critical to understand the origin of adverse events and the delivery of nondamaging stimulation.
Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. Several deep brain nuclei have been stimulated, producing a wide range of effects on the motor and non-motor symptoms of Parkinson's disease. Long-term, high-quality evidence is available for stimulation of the subthalamic nucleus and globus pallidus internus, both of which uniformly improve motor features, and for stimulation of the thalamic ventralis intermedius, which improves tremor. Short-term data are available for stimulation of other deep brain targets, such as the pedunculopontine nucleus and the centremedian/parafascicular thalamic complex. Some non-motor symptoms improve after DBS, partly because of motor benefit or reduction of drug treatment, and partly as a direct effect of stimulation. More evidence on the effects of DBS on non-motor symptoms is needed and specifically designed studies are warranted.
Using Transcranial Direct Current Stimulation to Treat Depression in HIV-Infected Persons: The Outcomes of a Feasibility Study. [2021]Transcranial direct current stimulation (tDCS) is a novel non-invasive neuromodulatory method that influences neuronal firing rates and excitability of neuronal circuits in the brain. tDCS has been shown to relieve Major Depressive Disorder (MDD) in the general population, suggesting its potential for other vulnerable populations with high MDD prevalence.
Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. [2022]Idiopathic Parkinson's disease (IPD) is a neurodegenerative disorder, with the severity of the disability usually increasing with disease duration. IPD affects patients' health-related quality of life, disability, and impairment. Current rehabilitation approaches have limited effectiveness in improving outcomes in patients with IPD, but a possible adjunct to rehabilitation might be non-invasive brain stimulation by transcranial direct current stimulation (tDCS) to modulate cortical excitability, and hence to improve these outcomes in IPD.
Noninvasive Brain Stimulation and Implications for Nonmotor Symptoms in Parkinson's Disease. [2018]Transcranial noninvasive brain stimulation includes both repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). TMS uses a rapidly changing magnetic field to induce currents and action potentials in underlying brain tissue, whereas tDCS involves the application of weak electrical currents to modulate neuronal membrane potential. In this chapter, we provide a literature review with a focus on the therapeutic potential of both techniques in the treatment of nonmotor symptoms of Parkinson's disease (PD). On the whole, the results of studies are rather preliminary but promising as they show some positive effects of rTMS and tDCS particularly on depressive symptoms and cognitive dysfunctions in PD. More carefully controlled trials with standardized methodology, adequately sized and well-characterized samples, and the inclusion of multimodal approaches are warranted in the future.
Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. [2018]We present device standards for low-power non-invasive electrical brain stimulation devices classified as limited output transcranial electrical stimulation (tES). Emerging applications of limited output tES to modulate brain function span techniques to stimulate brain or nerve structures, including transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial pulsed current stimulation (tPCS), have engendered discussion on how access to technology should be regulated. In regards to legal regulations and manufacturing standards for comparable technologies, a comprehensive framework already exists, including quality systems (QS), risk management, and (inter)national electrotechnical standards (IEC). In Part 1, relevant statutes are described for medical and wellness application. While agencies overseeing medical devices have broad jurisdiction, enforcement typically focuses on those devices with medical claims or posing significant risk. Consumer protections regarding responsible marketing and manufacture apply regardless. In Part 2 of this paper, we classify the electrical output performance of devices cleared by the United States Food and Drug Administration (FDA) including over-the-counter (OTC) and prescription electrostimulation devices, devices available for therapeutic or cosmetic purposes, and devices indicated for stimulation of the body or head. Examples include iontophoresis devices, powered muscle stimulators (PMS), cranial electrotherapy stimulation (CES), and transcutaneous electrical nerve stimulation (TENS) devices. Spanning over 13 FDA product codes, more than 1200 electrical stimulators have been cleared for marketing since 1977. The output characteristics of conventional tDCS, tACS, and tPCS techniques are well below those of most FDA cleared devices, including devices that are available OTC and those intended for stimulation on the head. This engineering analysis demonstrates that with regard to output performance and standing regulation, the availability of tDCS, tACS, or tPCS to the public would not introduce risk, provided such devices are responsibly manufactured and legally marketed. In Part 3, we develop voluntary manufacturer guidance for limited output tES that is aligned with current regulatory standards. Based on established medical engineering and scientific principles, we outline a robust and transparent technical framework for ensuring limited output tES devices are designed to minimize risks, while also supporting access and innovation. Alongside applicable medical and government activities, this voluntary industry standard (LOTES-2017) further serves an important role in supporting informed decisions by the public.
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]Transcranial direct current stimulation (tDCS) is an in-demand form of neuromodulation generally regarded as safe and well tolerated. However, few studies have examined the safety, tolerability, or blinding of High Definition (HD-) tDCS, especially in older adults and at stimulation intensities of 2 milliamps (mA) or greater.
Cerebellar Cortex as a Therapeutic Target for Neurostimulation. [2022]Non-invasive stimulation of the cerebellum is growingly applied both in the clinic and in research settings to modulate the activities of cerebello-cerebral loops. The anatomical location of the cerebellum, the high responsiveness of the cerebellar cortex to magnetic/electrical stimuli, and the implication of the cerebellum in numerous cerebello-cerebral networks make the cerebellum an ideal target for investigations and therapeutic purposes. In this mini-review, we discuss the potentials of cerebellar neuromodulation in major brain disorders in order to encourage large-scale sham-controlled research and explore this therapeutic aid further.
Current challenges: the ups and downs of tACS. [2020]The non-invasive delivery of electric currents through the scalp (transcranial electrical stimulation) is a popular tool for neuromodulation, mostly due to its highly adaptable nature (waveform, montage) and tolerability at low intensities (
Non-invasive Transcranial Electrical Stimulation in Movement Disorders. [2020]Dysfunction within large-scale brain networks as the basis for movement disorders is an accepted hypothesis. The treatment options for restoring network function are limited. Non-invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation are now being studied to modify the network. Transcranial electrical stimulation (tES) is also a portable, cost-effective, and non-invasive way of network modulation. Transcranial direct current stimulation and transcranial alternating current stimulation have been studied in Parkinson's disease, dystonia, tremor, and ataxia. Transcranial pulsed current stimulation and transcranial random noise stimulation are not yet studied enough. The literature in the use of these techniques is intriguing, yet many unanswered questions remain. In this review, we highlight the studies using these four potential tES techniques and their electrophysiological basis and consider the therapeutic implication in the field of movement disorders. The objectives are to consolidate the current literature, demonstrate that these methods are feasible, and encourage the application of such techniques in the near future.
Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. [2022]Objective.Non-invasive brain stimulation has been promoted to facilitate neuromodulation in treating neurological diseases. Recently, high-definition (HD) transcranial electrical stimulation and a novel electrical waveform combining a direct current (DC) and theta burst stimulation (TBS)-like protocol were proposed and demonstrated high potential to enhance neuroplastic effects in a more-efficient manner. In this study, we designed a novel HD transcranial burst electrostimulation device and to preliminarily examined its therapeutic potential in neurorehabilitation.Approach.A prototype of the transcranial burst electrostimulation device was developed, which can flexibly output a waveform that combined a DC and TBS-like protocol and can equally distribute the current into 4 × 1 HD electrical stimulation by automatic impedance adjustments. The safety and accuracy of the device were then validated in a series ofin vitroexperiments. Finally, a pilot clinical trial was conducted to assess its clinical safety and therapeutic potential on upper-extremity rehabilitation in six patients with chronic stroke, where patients received either active or sham HD transcranial burst electrostimulation combined with occupational therapy three times per week for four weeks.Main results.The prototype was tested, and it was found to comply with all safety requirements. The output parameters were accurate and met the clinical study needs. The pilot clinical study demonstrated that the active HD transcranial burst electrostimulation group had greater improvement in voluntary motor function and coordination of the upper extremity than the sham control group. Additionally, no severe adverse events were noted, but slight skin redness under the stimulus electrode immediately after stimulation was seen.Conclusions.The results demonstrated the feasibility of incorporating the HD electrical DC and TBS-like protocol in our device; and the novel neuromodulatory device produced positive neurorehabilitation outcomes in a safe fashion, which could be the basis for the future clinical implementation for treating neurological diseases.Trial registration:ClinicalTrials.gov Identifier: NCT04278105. Registered on 20 February 2020.