Table 4. Sham-controlled studies of DBS in OCD patients.
| Study | N | Age, Years (Range) | Female/ Male (N) | Design | Observation (Months) | DBS Target | Results/Conclusions |
|---|---|---|---|---|---|---|---|
| Mallet et al., 2008 [97] | 17 | 43.05 (29-56) | 7/10 | Randomized, double-blind, crossover study: two 3-month, and a 1-month washout phases | 10 | Subthalamic nucleus | Active (second) vs. sham (first) stimulation of the subthalamic nucleus: Y-BOCS scores was significantly lower. |
| Goodman et al., 2010 [89] | 6 | 36.2 (27-52) | 4/2 | Randomized, staggered-onset study: either 30- or 60-days (blind) stimulation following surgery | 12 | Ventral capsule/ ventral striatum, bilaterally | 12 months of active stimulation: response in 66.7% (≥35% Y-BOCS improvement or Y-BOCS severity ≤16). Sham stimulation: no improvements. |
| Denys et al., 2010 [95] | 16 | 42.56 (21-59) | 7/9 | Three sequential treatment phases: open 8-month treatment phase; double-blind crossover phase with 2-weeks of active or sham stimulation; open 12-month maintenance |
21 | Nucleus accumbens, bilaterally | Bilateral nucleus accumbens DBS may be an effective and safe treatment. Open phase: 46% Y-BOCS decrease; double-blind, sham-controlled phase: active vs. sham treatment showed 25% Y-BOCS score difference |
| Baas et al., 2014 [92] | 8 | 39.2 (27-60)* | 4/4 | Double-blind, crossover study; 2-weeks of active or sham stimulation | 1 | Ventral internal capsule, bilaterally | Decrease in OC, anxiety, and depressive symptoms. |
*Patients were all from Denys et al. [95]. DBS, deep brain stimulation; Y-BOCS, Yale-Brown Obsessive Compulsive Scale.