Brain Device Research and the Underappreciated Role of Care Partners before, during, and Post-Trial

The number of clinical trials for experimental brain implants continues to grow, and with this growth comes an increased reliance upon patients with treatment-refractory conditions to volunteer as participants in these studies. Sankary et al. (2022) provided insight into participants’ experiences exiting brain device trials, a topic of great interest in neuroethics (Fins 2009; Lázaro-Muñoz et al. 2018, 2022). However, the burdens associated with trial participation trials are not limited solely to participants. The demands of device trials and severity of the conditions being treated often require that participants have dedicated care partners—typically a family member or close friend—who assist with research-related decision-making and adherence to study protocols, while also providing day-to-day care and support to participants. Despite their important role in research efforts, little is known about care partner perspectives and experiences before, during, and after brain device trials. Sankary et al. (2022) provided data from interviews conducted with participants as well as a care partner; however, they did not differentiate between the views of participants¹ (n = 15) from those of the care partner (n = 1) included in the study. In contrast, Fins and Wright (2022) have identified differential perceptions of risk by subjects and care partners. Beyond these preliminary studies, it is essential to actively engage care partners and gain insight into their perspectives for three reasons.

CARE PARTNER-PARTICIPANT RELATIONSHIP

First, the relationship between care partners and participants with treatment-refractory conditions plays a critical role in the decision-making and care of participants during and after the trial. This is even more pronounced when participants lack decision-making capacity. Care partners endure strain associated with a loved one experiencing a severe treatment-resistant condition along with the stress that comes with the risks and efforts of participation (e.g., time-consuming data collection, neurosurgery or novel application of a device). This strain can have a meaningful impact on care partners’ psychological well-being, which may also impact their ability to support participants during and after the trial. Even for approved neurosurgical interventions, such as deep brain stimulation (DBS) for Parkinson’s disease (PD) and other common, even if not fully FDA-approved, indications such as childhood dystonia, clinicians heavily weigh the availability of social support and the availability of a dedicated care partner in determinations about patient candidacy because they believe this support is critical to positive patient outcomes (Kubu and Ford 2017; Torgerson et al. 2022). This raises the question of equity for those who do not have care partners and underscores the importance of examining care partner perspectives and their support needs to ensure they are well-positioned to assist recipients of these devices.

Care partners often report feelings of anxiety, depression, and apathy related to the stressors involved in caring for a loved one with a treatment-refractory condition. A recent systematic review of the literature found that even after successful DBS for PD, care partners continue to experience similar levels of psychiatric distress (van Hienen et al. 2020). Further, reported levels of care partner burden often remain unchanged after DBS, suggesting that while the patient may benefit from the device, there are on-going burdens that care partners continue to experience. Recent work has revealed that care partner burden can worsen following DBS for PD, with one study reporting increased burden two years post-operatively (Jackowiak et al. 2020). There are likely additional unique burdens associated with caring for an individual who is participating in an experimental device trial for new indications, where benefits and burdens exist in equipoise; however, to our knowledge, there is no extant literature that speaks directly to these burdens. It is critical to better understand the perspectives of care partners to identify these burdens and ascertain ways to lighten their load, recognizing their unheralded efforts in support of successful study outcomes.

CARE PARTNER-RESEARCHER RELATIONSHIP

Second, the care partner-researcher relationship, care partners are key intermediaries between the participant and clinical research team during the trial. Care partners generally have longstanding relationships with participants and possess expert knowledge about their level of functioning and typical behaviors. This expertise makes them an invaluable source of information regarding treatment response and the effects of the technology on the participant. A study of healthcare providers’ experiences related to the social and relational aspects of DBS highlighted the importance of collateral information in determining whether or not patients experience unwanted neuropsychiatric side effects or cognitive and behavioral disturbances as a result of stimulation (Bell et al. 2011). For brain device trials involving participants who may have limited insight into their cognitive, affective, or behavioral symptoms (e.g., DBS trials for Alzheimer’s disease or TBI), care partner reports may be one of the primary outcome measures to assess efficacy and adverse effects experienced by the participants. Gaining care partners’ perspectives surrounding their experiences during and after a trial could help clinical research teams identify unmet needs and gaps in support of the participant and the research.

LOSS OR CHANGE OF RELATIONSHIPS

Finally, the loss or change of these relationships when a device trial ends could have a profound impact on the care partner as they adjust to the loss or transformation of these roles. The research team often becomes a source of support for the care partner. Given the variable response to experimental devices, many participants may not experience alleviation of symptoms. If the participant doesn’t experience symptom relief or the device is explanted, care partners may face increased psychological distress as they navigate the loss of support from the research team. After the conclusion of a trial, participants may continue to live with their chronic and debilitating conditions and care partners may be faced with continued care responsibilities that may be complicated by a failed intervention.

Care partners may experience guilt if they supported their loved one’s decision to participate and the trial was either ineffective or led to adverse effects (Fins and Wright 2022). Further, in situations where the device improved the participant’s symptoms, care partners may be faced with challenges associated with reestablishing their own relationships, careers, hobbies, and life beyond their role as a care partner. This notion needs to be studied more comprehensively but qualitative evidence of care partner burden in DBS for PD revealed that it persisted post-operatively. This included being rejected by more independent patients who no longer need the care partner’s support (Gülke and Pötter-Nerger 2022).

Care partners also expressed experiencing communication issues with their loved ones post-DBS, as patients felt they were completely healthy and care partners maintained there were some lingering, or worsening symptoms (Gülke and Pötter-Nerger 2022). The opposite was also true, with patients reporting that they were failing to meet care partners’ expectations of their level of functioning after surgery (e.g., failure of patient to return to work or engage in social activities), which led to increased conflict (Gülke and Pötter-Nerger 2022). Overall, these findings from the DBS for PD literature illustrate the relational complexity experienced by care partners after a patient receives an implantable device and the need for more research surrounding care partners supporting participants in experimental device trials (Fins, Wright, et al. in press).

CONSIDERATIONS FOR FUTURE TRIALS

Understanding care partners’ perspectives and identifying ways to increase support will be an essential part of reciprocating care partners’ efforts for the success of these trials. One suggestion made by Sankary et al. (2022) was to connect clinical trial participants to resources for psychological support. We contend that these offerings of psychological support should also be expanded to include care partners, especially in light of findings from DBS studies showing the impact implantable devices can have on the relationships between patients and care partners (Fins, Wright, et al. in press). Initial findings from a recent pilot study utilizing a brief cognitive behavioral therapy (CBT) for care partners of patients who underwent DBS for PD demonstrated it was an effective intervention and a sustainable benefit at three-month follow-up appointments (Mosley et al. 2021).

Given the known efficacy of cognitive behavioral therapy (CBT) for many psychological conditions and its ability to be administered in both individual and groups settings, CBT may be a feasible and effective addition to the exit protocols of experimental device trials. Participants and their designated primary care partners could be given the opportunity to attend a brief series of group and/or individual CBT sessions in which a clinician with expertise in CBT as well as experience with device trials could facilitate sessions to assist with specific challenges associated with transitioning from a device trial. Sessions could foster effective communication between participants and care partners to promote long-term positive outcomes and this intervention could itself be subject to study. However, in order to design interventions or supports specific to the needs of care partners involved in experimental device trials, we must first determine what those needs are, which can only be done by engaging care partners in conversation. This exploration may also yield alternate mechanisms of support strategies to increase equity of access to invasive neurological trials for participants who do not have care partners.