Table 1.
Demographic and clinical characteristics.
| Value | Study 1
|
Study 2
|
||||
|---|---|---|---|---|---|---|
| Active (n = 15) |
Control (n = 20) |
p value | Active (n = 15) |
Sham (n = 12) |
p value | |
| Age (mean ± SD) | 53.4 ± 8.0 | 51.0 ± 12.7 | 0.50 | 44.8 ± 16.2 | 43.4 ± 16.2 | 0.83 |
| Gender (% female) | 66 | 65 | 1.00 | 53 | 67 | 0.70 |
| Race (% African American) | 13 | 15 | 0.80 | 33 | 33 | 1.00 |
| Ethnicity (% Hispanic) | 0 | 10 | 0.50 | 14 | 12 | 0.99 |
| Handedness (% right-handed) | 92 | 95 | 0.69 | 73 | 92 | 0.43 |
| Years education (mean ± SD) | 15.9 ± 2.6 | 14.8 ± 2.0 | 0.19 | 15.5 ± 2.0 | 16.1 ± 1.8 | 0.41 |
| Years with MS (mean ± SD) | 15.6 ± 8.9 | 15.7 ± 9.6 | 0.99 | 15.8 ± 9.4 | 13.3 ± 11.3 | 0.51 |
| Diagnosis (% RRMS) | 20 | 75 | 0.002 | 40 | 58 | 0.45 |
| EDSS (median and range) | 6.0 (1.0–8.0) | 4.0a (2.0–7.0) | 0.18 | 6.0 (0.0–7.0) | 3.5 (0.0–8.5) | 0.89 |
| Baseline FSS (% clinical fatigue) | 66 | 75 | 0.71 | 50 | 76 | 0.15 |
| Baseline PROMIS Fatigue (mean ± SD) | 26.9 ± 7.6 | 23.85 ± 5.8 | 0.19 | 26.6 ± 9.0 | 22.9 ± 7.9 | 0.30 |
| Baseline BDI category (% Category 1) | 50 | 65 | 0.15 | 50 | 64 | 0.84 |
SD: standard deviation; MS: multiple sclerosis; RRMS: relapsing–remitting multiple sclerosis; EDSS: Expanded Disability Status Scale; FSS: Fatigue Severity Scale; PROMIS: Patient-Reported Outcomes Measurement Information System; BDI: Beck Depression Inventory.
a
n = 8 due to missing EDSS data for Study 1 Controls.