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

Table 3 Changes in severity of cluster headache, emotional impact and quality of life, between baseline (before surgery) and the end of the open phase

	Before implantation (week 4) Median [range]	End of open phase (week 52) Median [range]	Difference between end of open phase and baseline Mean [95% CI]	P value
Attacks/week	14 [7; 53]	8 [0; 23]	8.16 [–18.3; 34.7]	0.082
Pain intensity	6 [2; 10]	4.5 [0; 10]	1.1 [–7.1; 9.3]	0.499
Sumatriptan (injections/week)	1 [0; 15]	0.5 [0; 26]	–0.1 [–11.3; 11.1]	0.288
HAD-A	13 [5; 18]	7.5 [0; 14]	6.3 [–5.1; 17.7]	0.008
HAD-D	10 [1; 16]	4.5 [1; 15]	4.1 [–6.48; 14.7]	0.052
SF12-MS	33.2 [27.5; 53.3]	37.0 [20.7; 56.6]	–0.6 [–26.5; 25.2]	0.953
SF12-PS	32.7 [24.4; 46.5]	39.7 [25.2; 50.5]	4.3 [–16.7; 25.3]	0.173

Severity of chronic CH has been assessed by weekly attack frequency, pain intensity (Liekert scale), and weekly sumatriptan injections, during the last week before surgery and at the end of the open phase. 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

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