Inner Ear Stimulation for Parkinson's Disease

(VEST Trial)

Overseen By Jaimie Barr, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Meniere disease, Stroke, Pregnancy, 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: Unknown

Duration: 1 week

64 Participants Needed

What You Need to Know Before You Apply

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.

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

Is inner ear stimulation for Parkinson's disease safe?

Non-invasive brain stimulation techniques like transcranial electrical stimulation (tES), including tDCS and tACS, are generally considered safe when responsibly manufactured and legally marketed. Studies have shown that these devices, which are used for various conditions, have output levels well below those of many FDA-cleared devices, suggesting they do not introduce significant risk. In clinical trials, no severe adverse events were noted, although slight skin redness under the electrodes can occur. ^{1 2 3 4 5}

How does the inner ear stimulation treatment for Parkinson's disease differ from other treatments?

The inner ear stimulation treatment for Parkinson's disease is unique because it uses a non-invasive neuromodulation device that applies electrical currents to the brain, unlike deep brain stimulation which involves surgical implantation. This method is portable, cost-effective, and aims to modulate brain networks without the need for surgery, potentially offering a safer and more accessible option for patients. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Inner Ear Stimulation for Parkinson's Disease?

Research shows that non-invasive brain stimulation techniques like transcranial direct current stimulation (tDCS) have shown promising results in improving nonmotor symptoms such as depression and cognitive dysfunctions in Parkinson's disease. These techniques are also being explored for their potential to improve movement disorders by modulating brain networks. ^{5 6 7 10 11}

Who Is on the Research Team?

Chatkaew Pongmala, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

Subjects limited by participation in research procedures involving ionizing radiation

Pregnancy (test within 48 hours of each PET session) or breastfeeding

I do not have conditions like PSP, MSA, or others that mimic Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational treatment stimulation pattern 1 or 2

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive neuromodulation device

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational Treatment 2 Experimental Treatment 1 Intervention

Investigational treatment stimulation pattern 2

Group II: Investigational Treatment 1 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

Transcranial noninvasive brain stimulation techniques, including rTMS and tDCS, show promising potential for treating nonmotor symptoms of Parkinson's disease, particularly depressive symptoms and cognitive dysfunctions.

Current studies are preliminary, highlighting the need for more rigorously controlled trials with larger, well-defined participant groups to better assess the efficacy and safety of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Brain Stimulation and Implications for Nonmotor Symptoms in Parkinson's Disease. Rektorová, I., Anderková, Ľ.[2018]

Transcranial direct current stimulation (tDCS) showed very low quality evidence for improving motor symptoms in patients with idiopathic Parkinson's disease (IPD), specifically reducing scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part III, but no significant effects on overall impairment or health-related quality of life were found.

The review included six trials with 137 participants, and while tDCS did not lead to higher dropout rates or adverse events compared to control, the overall evidence was insufficient to support its use as an effective treatment for IPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. Elsner, B., Kugler, J., Pohl, M., et al.[2022]

Non-invasive brain stimulation techniques, particularly transcranial electrical stimulation (tES), show promise in modifying brain network dysfunction associated with movement disorders like Parkinson's disease and dystonia, offering a cost-effective treatment option.

While techniques like transcranial direct current stimulation and transcranial alternating current stimulation have been studied, there is still a need for more research on newer methods like transcranial pulsed current stimulation and transcranial random noise stimulation to fully understand their therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Transcranial Electrical Stimulation in Movement Disorders. Ganguly, J., Murgai, A., Sharma, S., et al.[2020]

Transcranial direct current stimulation (tDCS) significantly reduced depression scores in HIV patients co-diagnosed with Major Depressive Disorder (MDD) after a 2-week treatment, indicating its potential as an effective intervention.

The treatment was found to be safe, with no serious adverse events reported, and participants expressed high satisfaction with the protocol, suggesting good acceptability for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Transcranial Direct Current Stimulation to Treat Depression in HIV-Infected Persons: The Outcomes of a Feasibility Study. Knotkova, H., Rosedale, M., Strauss, SM., et al.[2021]

Transcranial electrical stimulation (tACS) is a non-invasive method that can modulate brain activity by delivering electric currents through the scalp, but it faces challenges due to weak intracranial field strengths and potential transcutaneous effects.

Recent advancements in tACS techniques, such as high-frequency protocols and innovative current distribution methods, aim to improve the effectiveness of brain stimulation while minimizing unwanted effects from the scalp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current challenges: the ups and downs of tACS. Bland, NS., Sale, MV.[2020]

Limited output transcranial electrical stimulation (tES) devices, such as tDCS, tACS, and tPCS, have been shown to have electrical output levels significantly lower than many FDA-cleared devices, suggesting they pose minimal risk when responsibly manufactured and marketed.

The paper establishes a comprehensive framework for the regulation and manufacturing standards of low-power tES devices, promoting safety and innovation while ensuring public access to these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bikson, M., Paneri, B., Mourdoukoutas, A., et al.[2018]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

A novel high-definition transcranial burst electrostimulation device was developed and tested for safety, showing compliance with all safety requirements and accurate output parameters for clinical use.

In a pilot study with six chronic stroke patients, those receiving active stimulation combined with occupational therapy showed significant improvements in upper extremity motor function and coordination compared to the sham group, with no severe adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. Wang, SS., Huang, YJ., Chen, JJ., et al.[2022]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Non-invasive stimulation of the cerebellum shows promise for modulating brain activity and could be beneficial in treating major brain disorders, due to the cerebellum's unique anatomical position and responsiveness to stimuli.

The review emphasizes the need for more large-scale, sham-controlled studies to fully explore the therapeutic potential of cerebellar neuromodulation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar Cortex as a Therapeutic Target for Neurostimulation. van Dun, K., Mitoma, H., Manto, M.[2022]

Deep brain stimulation (DBS) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

Citations

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

Noninvasive Brain Stimulation and Implications for Nonmotor Symptoms in Parkinson's Disease. [2018]

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

Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Non-invasive Transcranial Electrical Stimulation in Movement Disorders. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Using Transcranial Direct Current Stimulation to Treat Depression in HIV-Infected Persons: The Outcomes of a Feasibility Study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Current challenges: the ups and downs of tACS. [2020]

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

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]

7. England pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. [2007]

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

Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. [2022]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

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

Cerebellar Cortex as a Therapeutic Target for Neurostimulation. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]