Stigma, Hope, and Access Across the Neuromodulation Spectrum: Converging Lessons from Established and Investigational Surgical Therapies for Mental Health
DOI: Pending DOI
Synopsis
Two parallel mixed-methods studies examined stakeholder perceptions of vagus nerve stimulation and prefrontal cortical stimulation for treatment-resistant depression, finding that stigma, insurance inequity, and access barriers constrain both an established and an investigational surgical therapy alike, underscoring the need to address these obstacles before, not after, clinical approval.
Background
Despite FDA approval for treatment-resistant depression (TRD) nearly two decades ago, vagus nerve stimulation (VNS) has been implanted in fewer than 5,000 depression patients compared to over 125,000 epilepsy patients. Prefrontal cortical stimulation (PCS), currently in first-in-human trials for TRD, has no established access pathway at all. Two parallel mixed-methods studies of VNS and PCS, examined whether the same barriers that constrain an established therapy also emerge before a new one reaches clinical practice.
Methods
Both studies combined validated questionnaires with semi-structured interviews using purposive sampling. The VNS-focused study (n=26) enrolled patients with TRD and epilepsy, clinicians, and support persons across two phases. The PCS-focused study (n=22) enrolled PCS-interested TRD patients, TRD patients not pursuing PCS, and members of the general public. Both assessed knowledge, attitudes, stigma, and barriers using overlapping instruments, with qualitative analysis in Dedoose and quantitative analysis in RStudio and SPSS.
Results
The same three barrier domains emerged independently across both studies. In the VNS-focused study, stigma was rooted in disease identity rather than the device: depression participants reported significantly greater experiences of shame and social rejection than epilepsy participants (p=0.001), clinicians and patients prioritized barriers differently (p=0.003), and depression patients waited an average of 27 years before VNS was offered compared to 5 years for epilepsy. In the PCS-focused study, objective PCS knowledge was comparable across groups (mean 78%, p=0.732) but self-rated confidence told a strikingly different story; PCS-interested participants rated themselves significantly higher in confidence about the treatment than the general public. Participants with prior neuromodulation experience reported higher levels of perceived community stigma (p=0.034), and insurance and cost emerged as dominant qualitative barriers even before the therapy is available. Hope was a defining theme: for patients with TRD, surgical neuromodulation represented the possibility of a life worth living after years of failed treatments. However, caution about invasiveness and the unknown was also a consistent theme.
Discussion
These findings demonstrate that barriers to surgical neuromodulation for mental health are structural and attitudinal, not technology-specific. They appear before a therapy reaches practice and persist decades after approval. For clinicians, researchers, and policymakers, this signals a clear imperative: addressing stigma and insurance inequity cannot wait until after approval. By then, the barriers are already ingrained.
Disclosures
The authors report no competing financial interests. This work was supported by the National Institutes of Health National Center for Advancing Translational Sciences (grants UM1TR004405 and 3U54AT012307-01S1). The content is solely the responsibility of the authors and does not reflect the official views of the NIH.