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Randomized clinical trial of deep brain stimulation for poststroke pain
Author(s) -
Lempka Scott F.,
Malone Donald A.,
Hu Bo,
Baker Kenneth B.,
Wyant Alexandria,
Ozinga John G.,
Plow Ela B.,
Pandya Mayur,
Kubu Cynthia S.,
Ford Paul J.,
Machado Andre G.
Publication year - 2017
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.24927
Subject(s) - deep brain stimulation , randomized controlled trial , brief pain inventory , mcgill pain questionnaire , medicine , physical therapy , placebo , clinical endpoint , adverse effect , beck depression inventory , crossover study , psychology , physical medicine and rehabilitation , chronic pain , anxiety , surgery , psychiatry , visual analogue scale , parkinson's disease , alternative medicine , disease , pathology
Objective The experience with deep brain stimulation (DBS) for pain is largely based on uncontrolled studies targeting the somatosensory pathways, with mixed results. We hypothesized that targeting limbic neural pathways would modulate the affective sphere of pain and alleviate suffering. Methods We conducted a prospective, double‐blinded, randomized, placebo‐controlled, crossover study of DBS targeting the ventral striatum/anterior limb of the internal capsule (VS/ALIC) in 10 patients with poststroke pain syndrome. One month after bilateral DBS, patients were randomized to active DBS or sham for 3 months, followed by crossover for another 3‐month period. The primary endpoint was a ≥50% improvement on the Pain Disability Index in 50% of patients with active DBS compared to sham. This 6‐month blinded phase was followed by an 18‐month open stimulation phase. Results Nine participants completed randomization. Although this trial was negative for its primary and secondary endpoints, we did observe significant differences in multiple outcome measures related to the affective sphere of pain (eg, Montgomery–Åsberg Depression Rating Scale, Beck Depression Inventory, Affective Pain Rating Index of the Short‐Form McGill Pain Questionnaire). Fourteen serious adverse events were recorded and resolved. Interpretation VS/ALIC DBS to modulate the affective sphere of pain represents a paradigm shift in chronic pain management. Although this exploratory study was negative for its primary endpoint, VS/ALIC DBS demonstrated an acceptable safety profile and statistically significant improvements on multiple outcome measures related to the affective sphere of pain. Therefore, we believe these results justify further work on neuromodulation therapies targeting the affective sphere of pain. Ann Neurol 2017;81:653–663