Table 3 RCT group differences in all assessments after six months

From: Spinal cord stimulation therapy for gait impairment in Parkinson’s disease: a double-blinded, randomised feasibility trial with an open extension

Outcome

MicroBurst

Sham

Baseline adjusted differences in means at 6-months (95% CI)

p-value

Baseline mean ± SD

6-month follow-up mean ± SD

Baseline mean ± SD

6-month follow-up mean ± SD

MDS-UPDRS subscores, lower score is better:

PIGD score

9.33 ± 3.9

9.0 ± 3.0

5.83 ± 2.6

6.83 ± 3.3

−0.69 (−3.23; 1.85)

0.556

LBG score

17.0 ± 4.6

14.3 ± 5.8

10.8 ± 2.5

11.2 ± 3.3

−2.93 (−8.3; 2.5)

0.252

Total motor score

41.83 ± 9.5

38.83 ± 10.6

32.0 ± 9.7

32.83 ± 8.0

−1.11 (−11.07; 8.84)

0.806

Patient reported gait and balance:

 NFOG-Q score,

lower score is better

22.17 ± 5.2

24.33 ± 3.4

21.4 ± 3.8

20.5 ± 3.9

3.48

(0.64; 7.59)

0.087

 ABC scale,

higher score is better

48.23 ± 17.3

39.18 ± 17.0

63.11 ± 12.8

59.17 ± 15.8

−15.17

(−39.69; 9.35)

0.195

 PDQ-39 mobility subscore,

lower score is better

52.5 ± 15.1 #

65.42 ± 12.0

37.92 ± 15.9

37.92 ± 9.9

29.22 (10.21; 48.23)

0.008*

 P-GIC at 6 months, a higher score is better

 

1.0 ± 0

 

1.33 ± 0.5

−0.33 (−0.80; 0.14)

0.145

Objective gait and balance:

 Berg’s Balance Scale,

higher score is better

48.67 ± 2.9

48.33 ± 4.3

52.0 ± 3.3

51.83 ± 4.7

−3.48 (−10.65; 3.69)

0.301

 TUG, sec

14.19 ± 5.8

14.75 ± 5.5

9.29 ± 1.8

9.82 ± 2.2

1.93 (−3.47; 7.33)

0.439

 TUG with cognitive

dual task, sec

19.99 ± 9.3

20.14 ± 7.1

10.1 ± 1.4

11.00 ± 1.7

5.61 (−2.53; 13.75)

0.154

 TUG with manual

dual task, sec

15.93 ± 5.7

16.72 ± 5.4

15.3 ± 8.2

16.67 ± 5.9

−0.33 (−5.26; 4.61)

0.884

 Modified Figure of Eight Test, sec

85.50 ± 50.5

151.72 ± 147.3

71.84 ± 70.2

56.60 ± 37.0

77.03 (−21.97; 176.02)

0.112

 20 m regular walk, sec

18.75 ± 2.3

21.71 ± 9.0

17.63 ± 3.8

17.42 ± 3.1

2.84 (−4.65; 10.32)

0.413

 20 m fast walk, sec

14.85 ± 3.5

21.14 ± 15.9

14.2 ± 2.8

14.70 ± 2.3

4.98 (−6.83; 16.78)

0.365

Patient reported quality of life:

 PDQ-39,

lower score is better

24.32 ± 4.3 #

32.09 ± 8.9

30.74 ± 7.3

32.69 ± 14.9

8.44

(−8.39; 25.27)

0.281

 SF-36 Physical score,

higher score is better

36.5 ± 11.0 #

34.92 ± 12.5

43.63 ± 12.3

42.85 ± 19.9 ##

−8.41

(−29.13; 12.30)

0.359

 SF-36 Mental score,

higher score is better

66.74 ± 10.1 #

63.78 ± 18.8

65.13 ± 12.0

53.71 ± 15.3

3.83

(−15.22; 22.87)

0.655

 MoCA,

higher score is better

26.0 ± 1.5

26.83 ± 1.5

27.17 ± 1.3

27.17 ± 2.6

0.39 (−2.54; 3.31)

0.773

  1. Results are presented as the baseline-adjusted between-group difference in end-of-treatment outcome values with a 95% confidence interval. The sham group was set as a reference. P-values from the between-group difference in means are presented. *: Significant, α = 0.05. Data obtained were not available for all patients (#: N = 5, ##: N = 4 indicate the number of participants with available data). ABC: Activities-specific Balance Confidence scale. LBG: Lower Body and Gait subscore from the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale. m: metres. MDS-UPDRS: Movement Disorder Society-Unified Parkinson’s Disease Rating Scale. MOCA: Montreal Cognitive Assessment. NFOG-Q: New Freezing of Gait Questionnaire. P-GIC: Patient Global Impression of Change. PIGD: Postural Instability and Gait Difficulty subscore of the MDS-UPDRS. PDQ-39: Parkinson’s Disease Questionnaire. sec: seconds. SD: standard deviation. SF-36: Short Form Health Survey. TUG: Timed-up-and-go. Source data are provided as a Source Data file.
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