Patient- and Technician-oriented Attitudes toward Transcranial Magnetic Stimulation Devices

Abstract

Introduction

Four Transcranial Magnetic Stimulation (TMS) devices are currently approved for use in treatment-resistant depression. We present the first data-driven study examining the patient- and technician-experience using three of these devices.

Methods

The study utilized a retrospective survey design with both patient and technician arms. The study population included patients who received TMS for treatment-resistant depression at the BACNBS for the first time between 2013 and 2016 and technicians who worked in the program from 2009 to the 2017. Statistical analysis included t-tests and ANOVAs to assess differences between and across the multiple groups, respectively.

Results

Patients treated on the Neurostar device reported greater confidence that the treatment was being performed correctly than those treated with Magstim (p<0.05). Conversely, with regard to tolerability, patients treated with the Magstim device reported less pain in the last week (p<0.05) and less pain on average (p<0.05) than those treated with the Neurostar device. On average, technicians reported feeling that both Magstim and Neurostar were significantly easier to use than Deep TMS (p<0.001). Additionally, they found the former two devices to be more reliable (p<0.001) and better tolerated (p<0.001). Furthermore, the technicians reported greater confidence in Magstim and Neurostar than in Deep TMS (p<0.01) and reported that they would be more likely to recommend the two former devices to other treatment centers (p<0.001).

Discussion

This study provides the first evidence-based investigation of patient and technician attitudes toward distinct TMS devices used in the treatment of depression.

Introduction

Transcranial Magnetic Stimulation (TMS) offers a meaningful treatment option for patients with medication-refractory major depressive disorder.^1,2,3 The FDA has cleared four distinct TMS devices for treatment-resistant depression: the NeuroStar TMS Therapy System from Neuronetics Inc. in 2008⁴, the Deep TMS H System from Brainsway Ltd in 2013⁵, the Magstim Rapid² Therapy System from Magstim Company Ltd in 2015⁶, and the Magvita TMS Therapy device from Magventure in 2015⁷. The first three devices have been in use in recent years as clinical treatment options at the Berenson Allen Center for Noninvasive Brain Stimulation (BACNBS) at Beth Israel Deaconess Medical Center in Boston, MA.

Across devices, the underlying principles of noninvasive brain stimulation are broadly overlapping; however, each machine utilizes a unique approach to achieve preferential stimulation over the dorsolateral prefrontal cortex. While the Magstim⁶ and the Magvita⁸ devices both feature what is known as a “Figure of 8” coil,” the Neurostar⁴ machine uses a proprietary variation on this design with some differences in shape and function. The Brainsway Deep TMS⁵ device features yet another variation, utilizing an H-coil that incorporates multiple coil loops for synergistic magnetic field creation.

Little is known about how these devices compare with regard to patient and technician experience. The aim of this study was to obtain quantitative data regarding these experiences with each distinct device. We hypothesized that while no device has demonstrated an advantage in efficacy, there would be notable differences in perception of tolerability and usability across several domains of interest.

Methods

The study utilized a retrospective survey design with both patient and technician arms. It was approved under exempt status by the Institutional Review Board at Beth Israel Deaconess Medical Center and adhered to ethical standards set forth by the institution including all participants providing informed consent. The study population included patients who received TMS for treatment-resistant depression at the BACNBS for the first time between 2013 and 2016. One hundred fifty-seven patients were contacted and 67 (43%) were reached and agreed to participate. They provided informed consent and completed a phone survey consisting of 10 likert-type quantitative items regarding their treatment experience. Only five patients who received treatment with the Deep TMS device were enrolled in the study. Given the low number of participants, the patient-data from this device was excluded from the comparative analysis. However, descriptive findings are provided in Table 1. The technician arm involved a similar survey consisting of 5 likert-type quantitative items pertaining to each device. This questionnaire was sent to all technicians who had worked at the center between 2009 and 2016. Of those solicited, all ten completed the survey. 2009 was chosen as the start date as it was the first year that multiple devices were used clinically in the center.

Table 1.

Average patient ratings from 1–5 ranging from “None” to “Severe” and “Strongly Disagree” to “Strongly Agree”

	Neurostar	Magstim	Deep TMS
Pain in 1st Week	2.54	2.18	2.41
Pain in Last Week	1.74*	1.25*	1.38
Noise	2.56	2.88	2.69
Would Choose Same Device Again	3.61	3.46	3.47
Felt Safe	4.74	4.83	4.8
Anxiety (Avg first and last week)	1.75	2.07	1.98
Confidence in Device	4.54*	4.07*	4.34
Felt Tired After Treatment	1.74	2.26	1.92
HAMD % Change	46.9	44.9	18.5
BDI % Change	52.3	43.0	35.3

^*represents statistically significant difference

Statistical analysis (performed using JMP) included t-tests and ANOVAs to assess differences between and across the multiple groups respectively. Statistical significance was defined in these analyses as p<0.05, but trends where p<0.1 are also reported.

Results

Patient Experience

Among the 62 patients who received treatment with either the Magstim (n=31) or the Neurostar device (n=31), 38 (61%) were female and 24 (39%) were male. All patients completed their treatment course. Forty-four patients (71%) received a 10 Hz left-sided treatment protocol, 11 (18%) received a 20 Hz left-sided protocol, and 7 (11%) received a 1 Hz right-sided protocol. The portion of patients receiving 1 Hz, 10Hz, and 20 Hz protocols on each device were approximately equal with no significant differences. Any patients receiving Deep TMS (not included in analyses) were treated using the standard 18 Hz protocol for that device.

The two device groups did not differ significantly with regard to clinical outcome, with overall clinical response rate of 48% as defined by a 50% pre-to-post drop in their Beck Depression Inventory-II (BDI) score and 22.5% full remission rates.

Patients treated on the Neurostar device, however, reported greater confidence that the treatment was being performed correctly than those treated with Magstim (p<0.05). Conversely, with regard to tolerability, patients treated with the Magstim device reported less pain in the last week (p<0.05) and less pain on average (p<0.05) than those treated with the Neurostar device. Magstim patients also reported feeling more tired on average than their Neurostar counterparts, although this difference was not statistically significant (p=0.063). A Cohen’s d was calculated to be 0.40, indicating a medium effect size of this finding.

Among the different protocols, the patients assigned to the 20 Hz protocol reported significantly more anxiety (ANOVA, p<0.05) and endorsed feeling less safe (ANOVA, p<0.05) in comparison to the 1 and 10 Hz protocols.

Technician Experience

Due to the timing of its acquisition, BACNBS utilized the Deep TMS device for fewer than 500 sessions versus the >2500 performed on each of the other two devices offered during the pertinent period of data generation.

On average over that incongruent sample, technicians did report feeling that both Magstim and Neurostar were significantly easier to use than Deep TMS (p<0.001). Additionally, they found the former two devices to be more reliable (p<0.001) and better tolerated (p<0.001). Furthermore, the technicians reported greater confidence in Magstim and Neurostar than in Deep TMS (p<0.01) and reported that they would be more likely to recommend the two former devices to other treatment centers (p<0.001).

Technicians’ reported no significant differences between the Magstim and Neurostar devices in the aforementioned areas (Table 2).

Table 2.

Average technician ratings from 1–5 from “Strongly Disagree” to “Strongly Agree”

	Neurostar	Magstim	Deep TMS
Easy to Use	4.3	4.6	2.6
Well Tolerated by Patients	4.4	4.4	2.29
Reliable	4.2	4.4	2.71
Confident in Device Efficacy	4.7	4.4	2.57
Would Recommend to Other Providers	4.6	4.6	2.14

^*In each item, Deep TMS was significantly different than Neurostar and Magstim, which were not significantly different from each other.

Discussion

This study provides the first evidence-based investigation of patient and technician attitudes toward distinct TMS devices used in the treatment of depression. Each device utilizes distinct approaches to clinical applications of TMS and each manufacturer has approached the clinical market in distinct ways; thus, it is valuable for the field to better understand patient and technician experiences as they relate to the distinct devices. Our analysis is uncorrected for multiple comparisons and, as such, should be considered exploratory.

While there were notable areas of overlap and functional equivalence, including overall efficacy between at least two of the devices, there were also respective strengths and weaknesses across devices. One meaningful finding was that patients on the Neurostar machine were more confident that the treatment was performed correctly, despite technicians reporting no differences between confidence using this device and the Magstim device. The Neurostar device notably features a proprietary medical chair and functional head-rest that are necessary components of the treatment while the Magstim features more versatility and is capable of being used as a hand-held device or with any number of company-endorsed accessories (e.g. chair, coil-stand). It is difficult to assess if this finding of greater patient-confidence in Neurostar relates to the device’s appearance, functionality, or actual technician skill, but the resulting perception is nevertheless experienced by patients in a manner that may in fact enhance their clinical experience.

In contrast, with regard to tolerability the patients treated with the Magstim device reported less pain than their counterparts treated with the Neurostar. It is worth speculating about a plausible connection between this finding and the previously discussed increased patient-confidence in the Neurostar device as it is possible that patients’ perception of pain on the Neurostar device in some way contributed to their confidence that the device was working. Notably, however, none of these perceptions seemingly affected likelihood of choosing the same device again, as there were no differences between groups on that item.

The data also sheds some light on patient-experience with distinct frequency protocols used in depression treatment. Though no longer a first-line approach for most patients, the 20 Hz protocol has been used extensively in the past in our center and elsewhere, and seems to be associated with negative patient experiences of increased anxiety and feelings of being unsafe during treatment. We did not obtain qualitative data that could illuminate why they felt that way, and it is worth noting the many factors that could be different between these groups (including length of depression) but one could speculate that the intensity of the sound or more rapidly repetitive sensations of discomfort, even in a shorter protocol, could have played a role.

The Brainsway Deep TMS device is perhaps the most distinctive as a result of its H-coil design; however, due to the low number of patients enrolled during the inclusion period, the available results could not be used in the patient attitudes analysis. We were able to analyze technician-attitudes toward this device, however, because of a 100% response rate among our technicians over the last several years but this data must be observed with caution as its clinical use with very highly limited as compared to the other two. Acknowledging that limitation, our technicians consistently found the Deep TMS device wanting in the areas of ease of use, tolerability, reliability efficacy, as well as in terms of their likelihood to recommend to other providers. However, we feel that it would be premature to make meaningful conclusions about these findings as the data obtained featured a sample from just one clinical and research center where device familiarity and the center’s academic and research culture may have skewed the results.

Adding validity to this concern, inquired with another local TMS center at McLean Hospital, where the Brainsway Deep TMS device has been used extensively alongside the Neurostar device. According to staff response from this center, there were no differences among the devices on any survey item. Pending greater data collection and expansion to other centers, we would advise readers to view these results cautiously.

Other limitations of this study include that it was entirely retrospective in nature and featured small numbers of respondents in not only the Deep TMS device group but also in the 1 and 20 Hz protocols, respectively. Another limitation is the amount of time between treatments and survey administration, which varied, and for some participants was as long as 3 years.

Although they share similarities, the TMS devices used to treat medication-refractory depression are distinct and confer different patient and technician experiences. TMS providers must take into consideration the existing evidence about device-specific qualities when making decisions about which treatment to offer their patients. Furthermore, as increasing numbers of devices and protocols gain popularity, it is important for the field to monitor these parameters in order to optimally match patients with appropriate and individualized treatment.