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Table 2 Changes in severity of cluster headache, emotional impact and quality of life during the randomized phase

From: Safety and efficacy of deep brain stimulation in refractory cluster headache: a randomized placebo-controlled double-blind trial followed by a 1-year open extension

  Active stimulation followed by sham stimulation (On–Off group) (n = 5)
Median [range]
Sham stimulation followed by active stimulation (Off–On group) (n = 6)
Median [range]
Difference between active and sham stimulation in the On–Off group
Mean [95% CI]
Difference between active and sham stimulation in the Off–On group
Mean [95% CI]
P value (treatment effect)
Baseline (week 8) End of On period (week 12) End of Off period (week 17) Baseline (week 8) End of Off period (week 12) End of On period (week 17)
Attacks/week 11 [2–42] 18 [1–55] 6 [1–49] 16 [7–25] 14.5 [0–28] 9 [6–21] 0.2 [−24.0; 23.6] −2.7 [−25.7; 20.31] 0.927
Sumatriptan (injection/week) 7 [1–13] 0 [0–18] 1 [0–6] 11.5 [1–29] 12.5 [0–33] 6.5 [0–25] 2 [−9.0; 13] −5.3 [−24.1; 13.5] 0.349
Pain intensity 5.5 [4–9] 5 [3–8] 5.5 [3–8] 6 [2–9] 5.7 [0–10] 4.5 [2–9] 0 [−1.4; 1.4] 0.3 [−9.5; 10] 0.357
PGIC na 2 [1–7] 2 [1–6] na 2 [1–4] 4 [1–7] 0.8 [−20.1; 21.8] 1.3 [−4.2; 6.8] 0.853
HAD-A 8.8 [5–10] 8 [3–12] 6 [4–14] 11.5 [6–15] 8 [5–10] 9 [6–15] 0.2 [−23.6.1; 24.0] −2.6 [−25.5; 20.3] 0.927
HAD-D 8.5 [3–13] 9 [4–13] 1 [0–6] 9.5 [1–13] 4 [1–9] 8 [1–16] 1.3 [−22.4; 25.1] 5.3 [−1.08; 11.7] 0.154
SF 12-MS 33.1 [28.1–52.1] 34.5 [31.6–56.2] 30.3 [17.8–59.9] 36.4 [27.5–53.3] 48.9 [24.9–54.2] 36.7 [16–52.9] 5.8 [−12.8; 24.4] −8.7 [−27.3; 9.9] 0.197
SF 12-PS 29 [24.4–31.2] 28.3 [27.2–29.0] 33.8 [27.5–34.9] 34.7 [32.2–46.5] 37.9 [28.4–46.5] 43.4 [28.1–51.5] −3.9 [−13.1; 5.3] 2.8 [−15.4; 21] 0.197
  1. All carryover and period effects were not significant. P values are for the between-group comparison of the difference between active and sham stimulation during the last week of each period (weeks 12 and 17). Severity of chronic CH has been assessed by weekly attack frequency, pain intensity (Liekert scale), and weekly sumatriptan injections. Patient impression of change was recorded using the PGIC which is a 7-point scale (1 extreme improvement; 2 significant improvement; 3 mild improvement; 4 no change; 5 mild worsening; 6 significant worsening; 7 extreme worsening). Emotional impact was assessed by the French version of the widely used Hospital Anxiety and Depression scale (HAD). The HAD involves seven anxiety items alternating with seven depression items. Anxiety and depression are defined by anxiety (HAD-A) and depression (HAD-D) scores superior to 7, respectively. The health-related quality of life was evaluated using the French version of the short-form 12 questionnaire (SF12) used to derive to summary scores, physical (SF12-PS) and mental (SF12-MS) component summaries. Lower numbers indicate greater disability