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Table 5 Adverse events

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

AE related to surgery 2
 Superficial infection (hardware removal) (SAE) 1
 Neck pain along the lead 1
Transient AE related to test stimulation
(Resolving after voltage reduction or contact change)
 Complex oculomotor disturbancesa 4
 Loss of consciousness with hemiparesia (SAE) 1
AE and changes during “On” period 6
 Mild hunger increase 3
 Mild hunger decrease 1
 Mild libido decrease 2
AE and changes during “Off” period 8
 Mild hunger increase 2
 Mild hunger decrease 1
 Mild thirst increase 1
 Mild thirst decrease 1
 Mild libido decrease 1
 Increased testosterone level 1
 Shorten menstrual cycle 1
AE and changes related to chronic stimulation 8
 Facial flush attacks 1
 Changes in blood pressure response to posture 1
 Severe micturition syncopes (SAE) 1
 Basal blood pressure changes 0
 Basal heart rate changes 0
 Body temperature changes 0
 Moderate weight increase (5 kg) 1
 Mild hunger increase 1
 Mild hunger decrease 1
 Mild libido decrease 1
 Significant electrolyte changes 0
 Increased testosterone level 1
 Other significant hormonal changes 0
  1. SAE serious adverse event
  2. aThree patients reported a transient diplopia, one reported an impairment of gaze fixation without objective oculomotor paresis