Figure 1
TAPS device and data. (A) The prescription wrist-worn TAPS device was shipped directly to patients and was comprised of a stimulator, band containing TAPS-delivering electrodes, and cloud-connected base station that charged the device and streamed device logs to a centralized database. A user guide included with the device contained instructions for patients on setup, calibration, and usage of TAPS therapy. (B) Study data were derived from the healthcare provider-completed prescription form, device logs automatically generated during therapy home use, and a voluntary survey sent to patients after 90 days of therapy use. (C) For the first 40 sessions and every 7th session thereafter, the device prompted patients to perform a twenty-second postural hold before and after stimulation and prompted patients to self-rate their tremor improvement after stimulation. Tremor power, computed from postural hold accelerometry data of clean signal quality, was used to characterize tremor severity. Additionally, measurements were classified into patient-specific bands of High, Medium, and Low based on pre-stimulation tremor power.
eTable 1
Patient voluntary survey.
| SURVEY QUESTION |
|---|
| For how many years have you had hand tremor symptoms? [select one] ◦ Less than 5 years ◦ 5 – 10 years ◦ 10 – 20 years ◦ Greater than 20 years |
| How would you rate the overall tremor severity of your treated hand without using Cala Trio? [select one] ◦ Mild – mild tremor not causing difficulty in performing any activities ◦ Moderate – tremor causes difficulty in performing some activities ◦ Marked – tremor causes difficulty in performing most or all activities ◦ Severe – tremor prevents performing some activities |
| How many tremor medications have you tried prior to starting Cala Trio? [select one] ◦ None ◦ 1 ◦ 2 ◦ 3 ◦ 4 or more |
| How many tremor medications are you currently taking for your hand tremor? [select one] ◦ None ◦ 1 ◦ 2 ◦ 3 ◦ 4 or more |
| Have you changed your tremor medication dosage since starting Cala Trio? [select one] ◦ Discontinued use ◦ Reduced dosage ◦ Increased dosage ◦ Not changed, but plan to consult my doctor ◦ Not changed, nor do I plan to ◦ I am not on tremor medications |
| If Cala Trio were presented as an option at the same time as medications or surgical procedures, which would you choose? (1 = would choose first) [rank preferences from 1 to 3] • Cala Trio • Tremor Medications • Surgical procedures |
| Which activities would you most like Cala Trio therapy to help you with? (1 = Most important to you) [rank importance from 1 to 5] • Activities of daily living (e.g., eating, drinking) • Social activities • Hobbies • Professional responsibilities/work • Housework |
| Please rate the impact the Cala Trio has on the following activities. [for each, select “Much Improved”, “Improved”, “No Change”, “Worsened”, or “Much Worsened”] • Eating • Drinking • Handwriting • Social activities (e.g., dining with friends) • Medication management (e.g., opening pill bottle, eye drops, checking blood sugar) • Professional responsibilities/work (e.g., computer, phone, meetings, presentations) • Housework (e.g., cooking, fixing small things) • Personal hygiene/getting dressed (e.g., hair, makeup, shaving, tying a tie, buttons) • Hobbies (e.g., music, knitting, fishing, art) • Overall quality of life |
Table 1
Study population.
| POPULATION CHARACTERISTICS* | |
|---|---|
| Age (years, mean ± SD) | 71 ± 10 |
| Gender (% female)+ | 32% |
| TAPS prescriber specialty | |
| Neurologists (movement disorder specialists) | 26% |
| Neurologists (general, and other sub-specialists) | 45% |
| Family practice, internal medicine | 14% |
| Occupational or physical therapist | 3% |
| Other (incl. unknown) | 12% |
| Patient-reported tremor burden** | |
| Years with tremor symptoms | |
| <5 years | 13% |
| 5–10 years | 25% |
| 10–20 years | 30% |
| >20 years | 32% |
| Self-rated pre-TAPS tremor severity | |
| Mild | 4% |
| Moderate | 62% |
| Marked | 25% |
| Severe | 9% |
| Number medications tried prior to TAPS | |
| None | 12% |
| 1 | 22% |
| 2 | 25% |
| 3 | 19% |
| >4 | 23% |
| Number of current medications for tremor | |
| None | 38% |
| 1 | 41% |
| 2 | 17% |
| 3 | 4% |
| >4 | 0% |
| Most important area of therapeutic need | |
| Activities of daily living | 78% |
| Social activities | 6% |
| Hobbies | 7% |
| Professional responsibilities | 9% |
| Housework | 0% |
[i] * From N = 321 (full study population) prescription forms.
+ From N = 121 of the 321 for whom gender data was available.
** From N = 69 survey respondents.
Table 2
Descriptive Statistics of Usage and Effectiveness.
| ALL PATIENTS | AGE <65 | AGE ≥ 65 | |
|---|---|---|---|
| Usage patterns, mean (SD) | |||
| Sessions per week | 5.4 (4.5) | 4.8 (5.8) | 5.5 (4.2) |
| Days per week with at least one session | 3.2 (1.9) | 2.6 (2.0) | 3.4 (1.9) |
| Sessions per day on days when therapy used | 1.5 (0.6) | 1.5 (0.7) | 1.5 (0.6) |
| Device-measured outcomes, geometric mean (×geometric SD)* | |||
| Improvement ratio, all sessions | 3.5 (×4.1) | 4.4 (×3.2) | 3.3 (×4.3) |
| Improvement ratio, “High” tremor sessions | 9.1 (×6.2) | 15.9 (×7.2) | 8.1 (×5.9) |
| Improvement ratio, “Medium” tremor sessions | 3.7 (×4.6) | 4.6 (×3.4) | 3.5 (×4.9) |
| Improvement ratio, “Low” tremor sessions | 1.3 (×3.3) | 1.2 (×2.2) | 1.4 (×3.6) |
| Patient-rated outcomes | |||
| % Sessions rated “Improved” | 59% | 69% | 57% |
| % Sessions rated “No Change” | 38% | 29% | 40% |
| % Sessions rated “Worsened” | 3% | 2% | 3% |
[i] * Geometric mean and SD are analogous to arithmetic mean and SD of log-transformed data; and geometric SD represents ×/÷ factor change from geometric mean.
Figure 2
Effectiveness assessed through longitudinal home-use data. (A) TAPS effectiveness was summarized across all, and High/Medium/Low session groups. Error bars represent geometric mean ×/÷ 1 geometric standard error (equivalent in range to mean ± 1 standard error of log-transformed data). (B) Across all sessions, cumulative distribution of per-patient tremor reductions indicated clinically meaningful improvement for most patients. (C) Patient self-ratings of post-TAPS improvement were similar in distribution to motion-sensor ratings of post-TAPS improvement. (D) Frequency of post-stimulation tremor severity categories were broken down for each pre-stimulation severity group. TAPS improved tremor severity category for most sessions that started High or Medium, and maintained Low tremor for sessions that started Low.
Figure 3
Patient-reported outcomes. (A) Respondents rated effect of TAPS on various activities of daily living, with 84% of respondents indicating improvement in at least one of eating, drinking, or writing, and 65% of respondents indicating improvements in overall quality of life. (B) Survey respondents generally preferred TAPS over medication or surgical management of tremor.