Table 3.
TAPS device usage and effectiveness by age group and gender in the TX arm.
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|---|---|---|---|---|---|---|---|
| NUMBER OF SUBJECTS | ALL PATIENTS | AGE (YEARS) | GENDER | ||||
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| <65 | ≥65 | p VALUE | FEMALE | MALE | p VALUE | ||
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| N = 1 33 | N = 38 | N = 95 | N = 49 | N = 84 | |||
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| Usage patterns, Mean (SD) | |||||||
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| Number of sessions per week | 4.34 (4.12) | 3.03 (2.94) | 4.87 (4.41) | 0.0194 | 4.61 (5.12) | 4.19 (3.43) | 0.5740 |
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| Number of days per week with at least one session | 3.00 (2.17) | 2.28 (1.84) | 3.29 (2.23) | 0.0142 | 2.95 (2.26) | 3.03 (2.14) | 0.8416 |
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| Number of sessions per day on days when therapy used | 1.32 (0.49) | 1.25 (0.41) | 1.35 (0.52) | 0.3198 | 1.38 (0.68) | 1.29 (0.35) | 0.3446 |
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| Tremor power improvement ratio1, Mean (95% CI) | |||||||
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| Improvement ratio, all sessions | 3.51 (2.46–4.56) | 4.43 (2.48–6.36) | 3.16 (2.20–4.10) | 0.2841 | 2.98 (1.77–4.20) | 3.81 (2.30–5.32) | 0.4541 |
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| Improvement2 in BF-ADL score, Mean (SD) | |||||||
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| Improvement in BF-ADL score | 1.59 (3.07) | 1.81 (1.91) | 1.48 (3.50) | 0.0147 | 1.57 (2.27 | 1.59 (3.35) | 0.1355 |
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| BF-ADL individual task improvements2 in patients with ≥ 3 at baseline for each task, Mean (SE) | |||||||
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| Pour milk from a bottle | 0.92 (0.15) (N = 24, p < 0.0001) | ||||||
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| Insert an electric plug | 0.80 (0.21) (N = 20, p = 0.0013) | ||||||
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| Hold a cup of tea | 0.73 (0.11) (N = 40, p < 0.0001) | ||||||
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| Dial a telephone | 0.70 (0.18) (N = 20, p = 0.0009) | ||||||
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| Use a spoon to drink soup | 0.61 (0.11) (N = 46, p < 0.0001) | ||||||
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| Unlock front door | 0.50 (0.20) (N = 16, p = 0.0271) | ||||||
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| Pick up change | 0.37 (0.19) (N = 19, p = 0.0691) | ||||||
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| Write a letter | 0.31 (0.08) (N = 62, p = 0.0006) | ||||||
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1 Device-measured outcome, improvement ratio was defined pre-stimulation tremor power divided post-stimulation tremor power.
2 BF-ADL improvement, BF-ADL score changes defined as BF-ADL score at the end of one month minus BF-ADL score at baseline multiplied by –1. A positive value indicates improved ADL from baseline over one month.