For the 10 million patients living with Parkinson’s disease worldwide, the disease’s symptoms become all-consuming, affecting patients’ quality of life on a daily basis.
Neuromodulation devices for Parkinson’s disease aim to offer a more personalised approach to symptom management. And since their introduction in the early 2000s, neuromodulation treatment modalities for alleviating symptoms of the disease, such as deep-brain stimulation (DBS), have been improving, providing more targeted treatment with fewer side effects.
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According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation approaching of over $13bn in 2035, up from around $6.8bn in 2025.
Despite neuromodulation being a well-established treatment for Parkinson’s disease symptoms, research indicates that factors including geographic barriers and low socioeconomic status are associated with the underutilisation of treatments such as DBS.
Observers highlight that innovation in the Parkinson’s disease field is currently hindered by factors including funding barriers and outdated clinical trial approaches. However, the neuromodulation market’s ongoing growth holds the potential to improve access to neuromodulation therapies, bring down the high patient costs associated with therapies such as DBS, and drive continued innovation in the space given neuromodulation therapies’ demonstrable efficacy in Parkinson’s disease symptom management.
Unmet needs in Parkinson’s disease
The lack of any disease-modifying therapies (DMT) for Parkinson’s disease remains the field’s most significant unmet need. As a result, patients living with the condition must navigate the ongoing challenge of monitoring and managing daily behaviours such as sleep quality and diet in an effort to alleviate disease symptoms like tremors and uncontrollable muscle movements (dyskinesia).
Levodopa has been the gold standard pharmaceutical approach to Parkinson’s disease management since its US Food and Drug Administration (FDA) approval in 1975. However, according to the American Parkinson’s Disease Association (APDA), it is most effective at treating Parkinson’s symptoms such as slowness, stiffness, and tremor, while certain motor symptoms, particularly balance difficulties, tend to respond less well.
And although levodopa often results in improved symptom management, it is not effective for all Parkinson’s disease patients, and can result in diminishing returns regarding symptom management over time – imbuing patients with an “on-off” affect, where they cycle from being readily able to move to being immobile.
Meanwhile, the underlying causes of Parkinson’s disease comorbidities such as dementia and psychosis are often difficult to pinpoint and remain challenging to treat.
Neuromodulation enters the treatment pathway
For Parkinson’s disease, neuromodulation therapies and related technologies have a growing role in the management of the disease’s symptoms for patients who have not responded well or are experiencing diminishing returns with their medications. In the absence of DMTs, the standard of care at this time remains focused on disease symptom management.
As patients’ disease symptoms worsen over time, medications such as levodopa and combination therapies often get titrated up. According to Deanna Harshbarger, CEO of Cala Health, this means that for some patients, the side effects of medication can become “as big of a problem as patients’ current symptoms”, a factor that makes neuromodulation treatments a viable adjunct to symptom relief.
The leading neuromodulation approaches for managing Parkinson’s disease symptoms are deep-brain stimulation (DBS) and transcutaneous afferent patterned stimulation (TAPS) therapy.
These neuromodulation therapies have been demonstrated to improve patients’ quality of life. However, for DBS, research indicates that symptom relief for the likes of speech, balance and gait issues typically do not improve to the same extent as symptoms such as tremor, with this same reality true of TAPS therapy.
Meanwhile, Medtronic’s BrainSense, an adaptive DBS system that adjusts therapy in real time, became the first system of its kind to receive FDA approval in February 2025. Other emerging treatment modalities that also target the ventral intermediate nucleus of the thalamus (Vim), a brain region that plays a critical role in the tremor-related network of Parkinson’s disease, include focused ultrasound (FUS).
The key difference among these options for Parkinson’s disease symptom relief are their degrees of invasiveness.
“Most patients considered for DBS have already explored various pharmaceutical options, with DBS considered as a next step for patients whose symptoms are no longer adequately managed by medication alone,” explains Rebecca Wilkins, divisional vice president, R&D neuromodulation at Abbott.
Abbott’s DBS offerings for Parkinson’s disease symptom management include Liberta RC. “While DBS can and does often work alongside medication, its primary goal is to provide better symptom control,” says Wilkins, and to mitigate medication-induced side effects like dyskinesia, and to “ultimately reduce patients’ reliance on a strict medication regimen”.
While efficacious, DBS as an adjunct to medication requires Parkinson’s patients to have electrodes implanted into their brain, with the treatment modality representing a more invasive and costly approach to attaining symptom relief.
Harshbarger notes that DBS may also not be suitable for all patients. While DBS has a strong safety profile, the potential for post-operative side effects such as confusion, delirium, and cognitive decline may dissuade some patients from “going for that level of surgery” to realise reduced symptoms, she says.
For this reason, Cala has developed a TAPS therapy approach for treating Parkinson’s disease symptoms via the delivery of neuromodulation via a wearable wristband. Harshbarger points out that TAPS therapy affects the Vim “utilised to treat patients with DBS – but non-invasively”.
Harshbarger says: “The thought process around why you would treat a patient with TAPS therapy versus DBS comes down to the fact that you have a patient that has a neurodegenerative disease that changes over time, and so along that pathway, there are different times for different treatments for patients”, with DBS typically more suitable for those at the more advanced stages of Parkinson’s disease.
“We feel the Cala’s TAPS therapy more readily fits into that pathway because a lot of patients just won’t go to DBS,” Harshbarger adds.
Closing the care gap with continuous patient data
As with any chronic disease, Parkinson’s patients live with the disease’s impact every day, at varying degrees of intensity.
The collection of data, while not a panacea for Parkinson’s disease, may represent an opportunity to advance therapeutic development and tailor treatment interventions depending on individual patient needs. However, achieving this degree of insight can be a challenge, given that healthcare systems have traditionally been developed under an episodic care model.
To create more seamless, consistent experiences for patients and providers across all care settings that could help improve Parkinson’s disease care, Abbott is currently focused on further enhancing connected care technologies.
“As part of this, we’re investigating how we can leverage our extensive datasets to explore how machine learning and AI might identify patterns in the body to support more personalised insights for care,” says Wilkins.
Rune Labs’ approach to account for this episodic care gap comes in the form of StrivePD Guardian. Launched this April, coinciding with Parkinson’s Disease Awareness Month, the artificial intelligence (AI)-based tool is designed to help Parkinson’s patients track their symptoms and metrics including sleep quality against a 20,000-plus patient dataset. The tool’s rationale is to “more accurately translate” the day-to-day reality of living with the disease back to clinicians and centres on “passive data collection”, although patients can also input data if they wish to, explains Rune Labs CEO Amy Franzen.
StrivePD is not positioned as a replacement to primary care, Franzen says, but as a way to amplify what clinicians can do based on the data that StrivePD collects.
Franzen explains: “When patients compare themselves to a cohort of other people with Parkinson’s disease, they can better gauge what, for example, their sleep patterns mean within the context of the disease.”
StrivePD’s launch comes at a time when, according to Franzen, Parkinson’s patients are beginning to advocate for more clinician input for their care while also taking care into their own hands. And the company’s app is primarily intended to help patients arrive at their episodic clinical appointments with questions and context that would be “impossible to understand without these objective measures”, according to Franzen.
From symptom management to disease modification
“DMTs are the north star that neuromodulation therapies for Parkinson’s disease have been aiming towards,” says Harshbarger.
In essential tremor, a condition with comparable symptoms to that of Parkinson’s disease, Cala’s PROSPECT study found that when patient consistently utilised their stimulation for one- to two-times per day, there was a statistically significant reduction in their underlying tremor after three months.
“For us to see that TAPS therapy was getting this reduction in underlying tremor suggests there is the ability to access these circuitries within the brain and to potentially rewire regions of the brain that have plasticity, and so I think there is potential for DMTs for Parkinson’s with the application of neuromodulation,” Harshbarger says.
With the current absence of DMTs for Parkinson’s disease, Franzen notes that symptom management is critical, and shares that Rune Labs thinks a lot about how the move towards Parkinson’s disease modification can be realised.
Franzen is convinced that one of the “most critical unlocks” for the development of successful DMTs is large datasets.
Other data collection initiatives for Parkinson’s disease are underway. Germany biotech Centogene’s approach with its ROPAD study, however, is focused more on characterising the genetics of PD to establish a better understanding of the disease progression, diagnosis, and treatment rather than the day-to-day symptoms of the disease.
Franzen says: “Large language models (LLMs) have made the ability to parse data the easy part. Collecting data is the hard part, and that’s where I get most excited about the success that Rune has had in getting patients into, and keeping them engaged, with our system.”
Over time, Franzen is convinced that Rune’s provision of insights to data will help shift the treatment landscape for Parkinson’s to disease modification. “And that then becomes the single most valuable thing that we can serve back to patients,” she concludes.
The undeniable reality of Parkinson’s disease is that R&D initiatives appear to have a dominant focus on the disease’s management opposed to DMTs. The initiatives being undertaken by companies within the field may hinge on data collection to gain new insights into how DMTs can be reached, yet the picture remains uncertain. Adaptive DBS remains a relatively new technology for Parkinson’s disease symptom management, and achieving DMTs may hinge on the further development of this technology, to which the ongoing growth of the neurological devices market shows promising signs, in confluence with revised clinical trial approaches that could result in new pharmaceutical candidates beyond the existing standard of care of levodopa.