My Experience With a ‘Vagus Nerve Stimulator’ Clinical Trial for Depression
Any medical information included is based on a personal experience. For questions or concerns regarding health, please consult a doctor or medical professional.
I wanted to hurl the tablet in my hands across the windowless room. I’d been answering questions about my severe depression for over three hours at the baseline visit for a research study. I was in the home stretch, fending off fatigue and migraine when a question on the screen broke me. It asked, “How many hours of work did you miss this week because of your depression (eg leaving work early)?” I’ve been too sick to hold down a job in years, but “does not apply” wasn’t an option. I felt a wave of self-doubt about whether my volunteer projects counted as work, then anger about living in a society where productivity is constantly used as a measure of wellness.
Trying to get into this study had forced me to confront a barrage of painful realities. Marinating in feelings of worthlessness after becoming disabled in my early 30s. Filling out forms that try to assign tidy “scores” to a messy, volatile condition. Jumping through endless hoops to get the care I need. My brain was like a shaken bottle of champagne, and this question abruptly popped the cork, releasing a chaotic stream of anger, grief, and despair.
My face felt hot and my grip on the tablet tightened. I whimpered as tears trickled down my cheeks, but the study coordinator didn’t look up from her computer.
“I have no idea how to answer this question,” I said. I tried to keep my tone level so I wouldn’t antagonize a key member of the research team.
“Just take your best guess, and try to be consistent in how you answer the question next time,” she replied in a distracted tone. To soothe myself, I thought the words I wished she was saying. You’re almost done. You’ve got this.
I was exhausted. Part of me wanted to get up and leave. But this study was my Hail Mary, my best chance of getting lasting relief from the intense sadness that made me wish I was dead. So I took a deep breath, chose an arbitrary number, and hit next.
This wasn’t the first time my treatment decisions had been affected by forces outside my control, usually insurance coverage, but this was a new level of powerlessness.
It had been a long road to this stuffy office full of infuriating, inflexible questionnaires. I was first diagnosed with depression during college, back when I thought it was something I could just treat with some pills and then get on with my life. I had some periods where my depression was in remission, but relief proved elusive after I became unable to work at the age of 33 due to multiple sclerosis and other chronic health conditions. I’d had big dreams for what I might accomplish with my two master’s degrees, and figuring out my new purpose continues to be an ongoing challenge.
My psychiatrist first mentioned the clinical trial in the winter of 2020. I was intrigued despite my aversion to implants after rocky experiences with a port and PICC line. It didn’t feel like a viable option in the short term, though, because I lived too far away from the study site to be eligible. There are 18 visits in the first year of the study, so the review committee wanted participants close enough that snowy roads or other travel delays wouldn’t be a concern. Considering we were still in the throes of a pandemic and I was in a high-risk group, relocating didn’t feel realistic.
Things changed after my depression became severe enough to require hospitalization, followed by a lack of response to 18 treatments of electroconvulsive therapy (ECT). Four days after my final ECT, I flew to the city where my psychiatrist is located to access a broader range of treatment options. The clinical trial still wasn’t my first choice, though. I’d confronted a lot of anxieties around invasive treatment with ECT, but felt an aversion to becoming a cyborg.
The study requires the surgical implantation of a battery-powered device called a vagus nerve stimulator (VNS). It’s like a pacemaker for the nervous system, sending electrical pulses at regular intervals. The FDA approved VNS for the treatment of depression way back in 2005, but the evidence of effectiveness wasn’t robust enough to persuade insurers to cover such an expensive option. The goal of this five-year study is to prove it’s worth the investment so coverage expands and VNS becomes accessible to more folks.
I went back and forth for over six months about whether I wanted to join the study. In the meantime, I tried transcranial magnetic stimulation, ketamine-assisted psychotherapy, and an antidepressant that made me constantly hungry. My depression didn’t budge, though, and eventually, I decided to pursue VNS. The first step was a phone screening to review my clinical history, which felt similar to a job interview. One of the main goals was to assess whether I met the eligibility requirement of having at least four “failed treatments” in my current episode of depression. Those treatments also had to meet requirements related to dose and duration. The amount of detail the study coordinator requested often felt overwhelming, both mentally and emotionally, but was only a preview of the difficult days ahead. In the wretched baseline visit that included the triggering question about work, the study coordinator also asked for details about my last four episodes of depression, and every medication I’ve tried for depression in my entire life. Remembering the dosages of medications taken over the span of nearly two decades would be hard for most people, and my MS brain fog plus severe depression made it even harder.
It often felt surreal to dig up painful memories in the hopes of proving I’d struggled long and hard enough to secure a spot in the study. There was the added challenge of worrying that I would overshoot, and be rejected for being too sad. My psychiatrist had mentioned the study didn’t accept people deemed to be too high of a suicide risk, because if a participant kills themself the researchers have to pause the study to reassess safety protocols. My mood had deteriorated in the months leading up to the baseline visit, but I couldn’t adjust my medications without delaying VNS because the study required at least 30 days of stable treatment. Due to an outbreak of COVID in the research team, I ended up having a period of almost two months where I couldn’t make any medication changes. I’d been stuck in a holding pattern, hoping I wasn’t crossing an invisible line that would exclude me from the study. During my baseline interviews, I felt plagued by anxiety that I wasn’t the “right” level of depressed in this high-stakes Goldilocks situation.
Most of the questions were challenging, some of them were infuriating, and a few felt downright silly. During one phone interview, the most baffling line of questioning kicked off with, “In the past seven days, how often would you say you looked sad?” When I said I didn’t know, she asked, “Well, how often did other people tell you that you looked sad?” I didn’t (and still don’t) understand the clinical relevance of other peoples’ superficial assessments of my internal experience, but muddled through a response. I thought it was a one-off question by an out-of-touch research clinician, but found out later this person was using a script. Just like “does not apply” wasn’t an option for that question about work, the protocol likely forced her to not only ask the question exactly as worded, but also choose an answer between 0 and 7. My psychiatrist had openly mocked some of the convoluted, often bordering on incoherent, questions she had to ask in the baseline interview. These moments of validation helped me cope with the frustrating fact that we’re all being forced to use rigid, sometimes flawed assessment tools selected by the study design board.
After my second visit, I waited for the decision. The study coordinator had told me I’d probably get an answer in three days, but no guarantees. I struggled to distract myself because it felt like someone had run my attention span through a shredder. For weeks, I’d been forgetting entire conversations and getting sidetracked when trying to complete tasks. I’d also graduated from night owl to vampire-level insomnia, which meant a lot of time alone with my thoughts.
After spending months psyching myself up about VNS, I worried I’d only set myself up for disappointment. I worried I wouldn’t be able to muster the energy to try something else if I was rejected from the study. This wasn’t the first time my treatment decisions had been affected by forces outside my control, usually insurance coverage, but this was a new level of powerlessness. Even if I was accepted, I was still subject to the whims of randomness because half of study participants are randomized into a control group, which means the device isn’t actually turned on for the first year. When I told my psychiatrist that was making me hesitant about the study, she said, “Yeah, but there’s a 100% chance it will be turned on in a year.” I tried to explain that wasn’t comforting, because I was struggling so much that a year felt like an eternity. In later visits, she reminded me that the study was the only way I could get a VNS. This only made me feel worse because it implied I was being ungrateful, a hostage to my circumstances, or both.
I got the email on Valentine’s Day. The subject line said “Approval!” I appreciated its directness, but the exclamation point implied an excitement I did not share. I only read the first line: “You officially qualify for the study.” Less than a month later, the VNS was implanted after a stressful rush to the finish line. Yet another quirk of the study was that if implantation didn’t occur within six weeks of the first baseline visit, I had to start the whole process again. This ended up meaning my surgical consult happened only three days before placement, leaving little time to digest a lot of new information. For example, I learned (for the first time) I needed to avoid lifting anything more than 25 pounds for six weeks after implantation.
I used to be a long-distance runner, and getting the VNS implanted felt like crossing the finish line. Recovery from surgery was physically painful, but I had the peace of mind that the darn thing was in me. Part of my anxious brain had expected a call or email telling me the study gods had changed their mind and I wasn’t actually going to get a VNS. Since the study is blind, I don’t know if my VNS was actually turned on, and the visits are often exhausting. But I was able to discontinue my antidepressant, and am feeling a little calmer about my future.
Participating in the clinical trial has been a difficult experience so far, and I won’t be finished answering these darn questionnaires for almost five more years. I only hope that when I look back on this experience, I feel like it was worth it.
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