Table 6.
Review of the studies investigating the clinical role for PH stimulation for the treatment of pain
| Study, Year | Study Type | Pain Type | Total-(Implanted)-Success | Electrode and Stimulation Parameters | Side Effects | Notes |
|---|---|---|---|---|---|---|
| Leone et al,103 2001 Leone et al,104 2004 |
CR | CH | 1-1-1 | Medtronic 3389, 180 Hz, 60 μs, 1–7 V | NFS | F-U: 42 mo |
| Franzini et al,105 2003 | CS | CH | 5-5-5 | Medtronic 3389, 180 Hz, 60 μs, 1–7 V | >4 V: conjugated eye deviation, extreme verbal reports (eg, “near to death”) | F-U: 2–22 mo |
| Franzini et al,106 2004 | CS | CH | 8-8-8 | Medtronic 3389, 180 Hz, 60 μs, 1–3.8 V | NFS | F-U: 2–26 mo |
| Schoenen et al,107 2005 | CS | CH | 6-4-4 | Medtronic 3389, 180 Hz, 60 μs, 1–3 V | Transient diplopia, dizziness | One patient died of intracerebral hemorrhage with ventricular inundation, F-U: 14.5 mo avg |
| Leone et al,108 2005 | CR | SUNCT | 1-1-1 | Medtronic 3389, 180 Hz, 60 μs, 1–4 V | >4 V diplopia | Patient underwent blind stimulator deactivation and symptoms reappeared |
| Leone et al,109 2006 | CS | CH | 16-16-16 | Medtronic 3389, 180 Hz, 60 μs, 1–7 V | Hemorrhage of the 3rd ventricle, diplopia | 9 patients stimulators turned off, single blind, and recurrence of symptoms, F-U: 23 mo |
| Broggi et al,110 2007 | CS | SUNCT, CH, FP | 20-?-14 | Medtronic 3389, 180 Hz, 60 μs, 1–7 V | NFS | 4 Cases of stimulation cessation leading to attacks, F-U: 23 mo avg |
| Starr et al,111 2007 | CS | CH | 4-2 | Medtronic 3387, 180 Hz, 60 μs, 0–3 V | NFS | — |
| Bartsch et al,112 2008 | CS | CH | 6-3 | Medtronic 3387, 3389, 130–185 Hz, 60 μs, 0–5.5 V | Vertigo and diplopia | F-U: 17-mo avg |
| Pinsker et al,113 2008 | CS | CH | 2-0 | Medtronic, 180–185 Hz, 60 μs, 3–5.5 V | NFS | Patients showed an initial response, by 3 mo pain returned |
| Fontaine et al,114 2010 | CT PC DB MC P |
CH | 11-6 | Medtronic 3389, 185 Hz, 60 μs, set to 3 V or 80% of side effects | Transient visual disturbances, hemiparesis, micturition syncope | Reported successes in open arm of the trial |
| Seijo et al,115 2011 | CS | CH | 5-5 | Medtronic 3389, 130 Hz, 60–12 μs, 2–3.5 V | Myosis, euphoria, diplopia | F-U: 33 mo avg |
Abbreviations: avg, average; CH, chronic headache; CR, case report; CS, case series; CT, clinical trial; DB, double blind; F-U, follow-up; FP, face pain; Hz, Hertz; NFS, not further specified; P, prospective; SUNCT, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing; V, volts.