- 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 post-stroke pain syndrome was conducted.
- 1 month after bilateral DBS, they randomized patients to active DBS or sham for 3 months, followed by cross-over for another 3-month period.
- The initial endpoint was a ≥ 50% improvement in 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.
- In this study, 9 participants completed randomization.
- The researchers did observe significant differences in multiple outcome measures related to the affective sphere of pain (e.g. Montgomery-Asberg Depression Rating Scale, Beck Depression Inventory, Affective Pain Rating Index of the Short-form McGill Pain Questionnaire) although this trial was negative for its primary and secondary endpoints.
- They recorded and resolved 14 serious adverse events.