- For more than a decade, Howard Eisenberg, MD, has been a cornerstone of the focused ultrasound program at the University of Maryland.
- His work primarily involves treating movement disorders – like essential tremor and Parkinson’s disease – and pain.
- The Maryland team offers focused ultrasound both in clinical trials and commercial treatments.
For more than a decade, Howard Eisenberg, MD, has been a cornerstone of the focused ultrasound program at the University of Maryland (UMD). As the Raymond K. Thompson, MD, Professor of Neurosurgery, he primarily uses focused ultrasound to treat movement disorders – like essential tremor and Parkinson’s disease – and pain.
We interviewed Dr. Eisenberg to learn about how he has built an experienced team with a patient-first mentality by offering focused ultrasound both in clinical trials and commercial treatments.
When and how did you get interested in focused ultrasound?
I first heard about focused ultrasound about 15 years ago from my good friend, Neal Kassell, MD, the founder of the Focused Ultrasound Foundation. I participated in one of the first large meetings the Foundation hosted, and it piqued my interest in how this technology could change patient care. However, at that time, the technology wasn’t available at UMD.
Then, when Elias Melhem, MD, came on board as Chair of Diagnostic Radiology and Nuclear Medicine, he had some prior knowledge and interest in focused ultrasound. That was when the university decided to invest in the equipment, and we began to explore the potential of focused ultrasound.
What are your areas of interest?
I primarily use focused ultrasound for ablation. I treat movement disorders like essential tremor (ET) and Parkinson’s disease (PD), as well as neuropathic pain. Our department also has some ongoing studies using focused ultrasound to open the blood-brain barrier (BBB), and I have helped with those treatments, but the bulk of my patients are ablation cases.
What kinds of patients do you treat at UMD?
Currently about half of the patients we treat are enrolled in clinical trials, and the other half are commercial patients.
We have clinical trials ongoing for bilateral PD, BBB opening for gliomas – see NCT03551249 and NCT04417088 – and trigeminal neuralgia. We also recently finished a clinical trial of focused ultrasound for neuropathic pain, and the results will be published in the near future.
We offer commercial focused ultrasound therapy for ET and the symptoms of tremor-dominant Parkinson’s disease (TDPD). That means that these indications are approved by the FDA and patients can opt for treatment as they would any other procedure.
Clinical Offerings for Commercial Patients
Are you currently treating patients commercially?
Yes, we offer focused ultrasound commercially to treat ET and TDPD. We are eager to treat additional PD patients following the recent FDA ruling, but there are reimbursement hurdles to overcome before we can do so.
What has your experience been with the reimbursement process?
We learned a lot about how the Centers for Medicare and Medicaid (CMS) coverage works through our experience with the treatments for ET. There are 12 regional Medicare Administrative Contractors (MACs) that are tasked with administering local Medicare plans, and unfortunately ours was one of the last to approve coverage for the treatment. In essence, we ended up at the back of the line for commercial ET treatments. But hopefully, the precedent set by the ET and TDPD rulings will help speed along decisions for other Parkinson’s patients.
How do you attract patients to your practice?
Most of our patients come to us from physician referrals or by patients finding us online. We don’t actively market the treatments.
Who coordinates your patient care and how do patients reach that person?
Shanell Watson is our first point of contact for patients. She can be reached at 410-328-3514.
Can you describe the patient intake process?
Ms. Watson speaks with patients first and gathers information about their diagnosis, medical history, and symptoms. Then, she and I will talk to the patient about focused ultrasound and any other relevant treatment options to determine the best treatment.
If we all decide to move forward in pursuing focused ultrasound, the next step is to have a consultation with a neurologist, which is generally Dr. Paul Fishman. Then, we request a CT scan for skull density and an MR scan and, if those results confirm candidacy, we will schedule the treatment.
Describe the treatment day protocol. How many follow-up appointments are required?
On the day of the focused ultrasound treatment, patients will first meet with a nurse and myself to discuss what will happen during treatment. I feel very strongly that patients be reminded of all their treatment options at this point as well to ensure that focused ultrasound is the direction they want to go.
Then, they will have their head shaved. Ultrasound does not travel through air, and hair creates air pockets that interfere with the treatment. Once the head is shaved, we attach the stereotactic frame to their skull. Local anesthetic is injected where the four bolts are tightened to ease discomfort, but patients do feel a sense of pressure that generally resolves quickly.
Once the frame is secure, we position the patient on the stretcher and attach the frame to the focused ultrasound helmet-like device. This step is essential to ensure that there is no movement of the head during treatment.
Patients are awake for the entire treatment because it is important for us to monitor their symptoms in real time. However, we do administer medication through an IV to maintain a low blood pressure. We can also offer anti-nausea medication – as sometimes patients experience slight nausea in the MR – and mild sedation to calm nerves.
Next, the patient goes into the MR machine, and we begin with some initial low-power sonications to ensure that we are targeting the correct location in the brain. These initial sonications do not cause tissue damage, but they allow for us to assess their symptoms and look for any off-target effects. During this time, we slide the patient in and out of the MR machine often for assessments.
Once the target is confirmed, we turn up the power and create lesions – or ablations – by heating a tiny area of brain tissue. We continue to perform assessments to monitor symptom changes during this time. It is important to note that patients do not feel the heat, and this method of brain lesioning has been done for many years through other methods like radiofrequency ablation.
After the treatment is complete, the patient comes out of the MR machine and the frame is removed. We examine their symptoms post-treatment, and they are asked to wait for a period of time. Patients return home the same day, though we always insist they don’t drive themselves.
We ask patients to return the next day for a follow-up MR scan, and any other follow-up appointments are conducted with the neurologist. These can be virtual or in-person based on the case and preference.
How do commercial patients go about securing reimbursement for the procedure? Does your office help with that?
We have dedicated billing personnel that handle the reimbursement requests for patients. Generally, the procedure is covered by Medicare, but sometimes secondary insurance refuses coverage. The patient is made aware of the cost before treatment.
What would you like patients to know about your site?
We have a lot of focused ultrasound experience, and we pride ourselves on being accommodating for patients. We also treat patients from all over the world and do our best to be expeditious when it comes to their time. Our wait time to schedule a procedure is generally only about a month.
Focused Ultrasound Research
Who are your team members?
Paul Fishman, MD, PhD, is the neurologist who I work closely with on all focused ultrasound cases. He assists with screening patients and completes treatment follow-up.
Dheeraj Gandhi, MD, is the head of the department of neuroradiology. He is leading the current clinical trials of focused ultrasound for trigeminal neuralgia and neuropathic pain. Dr. Gandhi and Timothy Miller, MD, a fellow neuroradiologist, also complete the tractography – or treatment location targeting – based on the pre-treatment MR prior to treatment.
Graeme Woodworth, MD, is a neurosurgeon and Director of the Brain Tumor Treatment & Research Center. He is interested in how focused ultrasound can disrupt the BBB, and he is currently leading clinical trials of BBB opening for glioblastoma.
Caitlin Henry is our research coordinator, and Shanell Watson helps with patient inquiries. We are also hoping to hire additional staff in the new year.
Who are your internal and external collaborators?
Our main external collaborators are the physicians at other sites participating in our clinical trials. This includes, but isn’t limited to, Michael Kaplitt, MD, PhD, at Weill Cornell Medicine, Rees Cosgrove, MD, at Brigham and Women’s Hospital, Vibhor Krishna, MD, at the University of North Carolina School of Medicine, Jeff Elias, MD, at the University of Virginia, Gordon Baltuch, MD, PhD, at Columbia University, Alon Mogilner, MD, from New York University Langone, and Vivek Buch, MD, at Stanford University.
What are your funding sources?
Our main funders for research have been the Focused Ultrasound Foundation and Insightec, the manufacturer of the Exablate focused ultrasound device. The University of Maryland Medical Center is also very supportive in providing the supplies and equipment necessary.
How many patients have you treated and for which indications?
We have treated more than 250 patients to date using focused ultrasound at UMD. I would estimate that half of those were for research in clinical trials, and the other half were commercial patients.
What has been your greatest achievement?
Our greatest achievement is the program itself. We started from ground zero, and we have – through the expertise of all involved – grown it to a very successful program treating patients across a range of conditions. Offering a noninvasive option to patients with an expanding list of diseases is the utmost achievement. It has also become a marquee program of sorts for the School of Medicine, and we are fortunate to have their support.
What is your research wish list?
We are always looking to grow the program. We have a bilateral PD clinical trial underway now, and I think success in that area will be a boon for focused ultrasound. For these movement disorders that affect both sides of the body, successful bilateral treatments will be necessary to establish focused ultrasound as a viable treatment option for patients.
There is also interest in exploring focused ultrasound–induced BBB opening for Alzheimer’s disease. The idea here is that the focused ultrasound can temporarily disrupt the BBB to allow a drug to reach the brain in high enough concentrations to increase efficacy. Those are the two main things that are within the pipeline now.
Did the Foundation play a role in your work?
The Foundation has supported our work immensely. In 2016, we became the Foundation’s fifth Center of Excellence, which recognized the program and spurred more projects. I am also encouraged by all of the Foundation’s efforts to galvanize the field.
Parkinson’s Dyskinesia Pilot Study Results Published December 2020
Investigator Profile: Dheeraj Gandhi, MD October 2018