Table 1.
Summary of clinical data on deep brain stimulation for psychiatric indications.
| References | Study design | N | Target | Indication | DBS parameters | Follow up (months) | Outcomes (primary) | Outcomes (secondary) | Side effects | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Frequency (Hz) | Intensity (V/mA) | Pulse Width (mcS) | |||||||||
| Abelson et al. (43) | Prospective blinded trial (on–off), open follow up | 5 | ALiC | OCD | 130–150 | 5–10.5 V | 60–210 | 4–23 | 1/5 with >35% reduction in YBOCS over baseline | Not defined | Mood changes, hypomania, transient sensory changes |
| Goodman et al. (44) | Randomized, staggered onset programming under blinded conditions | 6 | VC/VS | OCD | 130–135 | 2.5–8.5 V | 90–210 | 12 | YBOCS response rate 66.7% after 12 months, no improvement during sham programming period | HAM-D, POMS improved in both groups, 4/6 improved on CGI | Emotional changes, hypomania |
| Denys et al. (39) | Open lead in, double blind cross over, on–off, open follow up | 16 | NAcc | OCD | 130 | 3.5–5 V | 90 | 21 | YBOCS change- Open phase (mean 72% reduction), Double Blind (25% reduction mean active vs. sham) | Not defined | Mild forgetfulness, word finding difficulties |
| Dougherty et al. (45) | Multi-site sham controlled randomized trial with open label follow up | 33 | VC/VS | Depression | Not reported | Not reported | 90 or 210 | 24 | MADRS response rate not significantly different between active and sham (p = 0.53) | Not defined | Depression, insomnia, suicidal ideation, irritability, hypomania |
| Bergfeld et al. (46) | Open label optimization, randomized double blind, cross-over active/sham | 16 | ALiC | Depression | 130 or 180 | 2.5–6 V | 90 | 3 months open label, 4 weeks blinded cross-over, 1 year follow up | HAMD-17 difference active (13.6) vs. sham (23.1) (post open optimization phase) p ≤ 0.001 | MADRS, IDS-C significantly lower active vs. sham (p = 0.001) | Mania, nocturia |
| Holtzheimer et al. (47) | Multi-site randomized sham-controlled trial | 128 | SGACC | Depression | 130 | 4–8 mA | 91 | 6 months randomized sham-control with 6 months open label follow up | MADRS response not significantly different active vs. sham (20, 17%) | Not defined | Head pain, infection, worsening depression, suicide attempt, death by suicide |
| Merkl et al. (48) | Double blind randomized controlled trial | 8 | SGACC | Depression | 130 | 5–7 V | 90 | 24 | HAMD-24 baseline active vs. delayed onset 34.5, 32.5; at week 8 active vs. delayed onset 29.2, 31.2 (p = 0.291); at 24 months active vs. delayed onset 26.3, 15 (p = 0.49) | BDI-II most time points favored delayed onset with statistical significance, MADRS reductions at time points not significant | Hypomania, pulling sensation |
| Coenen et al. (49) | Double blind randomized controlled trial | 16 | SLMFB | Depression | 130 | 3 mA (SD 0.5 mA) | 60 | 12 | MADRS reduction 29.6–12.9 at 12 months | HAMD-28 −2.23 p = 0.03 | Strabismus |
| Barcia et al. (50) | Prospective randomized, double blind trial | 7 | NAcc and “striatal axis” | OCD | 130 | 4.5 | 60 | 21 | 6/7 Y-BOCS reduction >35%, all stimulation (including sham) statistically significant reduction vs. baseline | Best contact varied between patients | No cognitive adverse effects of striatal stimulation, no seizures |
| Polosan et al. (51) | Randomized, double blind, within subject design | 12 | STN | OCD | 130 | “Individually adjusted”-parameters not reported | 60 | None | Ratings of Pleasantness/Arousal when viewing differently valenced images- OCD ON DBS more positive ratings, no interaction effect | Not defined | Not reported |
| Mosley et al. (52) | Prospective blinded trial (on–off), open follow up | 9 | BNST | OCD | 130 | 4.5 | 90/120 | 15 | Mean change YBOCS (blinded −4.9 points, p = 0.025), MADRS (blinded −3.4 points, p = 0.3) | 7/9 patients >35% reduction in YBOCS after open label phase with CBT | 1 IPG infection, 1 lead migration, psychiatric admission in setting of non-response, reduced libido |
OCD, Obsessive Compulsive Disorder; ALiC, Anterior Limb of Internal Capsule; VC/VS, Ventral Capsule/Ventral Striatum; NAcc, Nucleus Accumbens; SgACC, Subgenual Anterior Cingulate Cortex; SLMFB, Superolateral Medial Forebrain Bundle; STN, subthalamic nucleus; BNST, Bed Nucleus of the Stria Terminalis; HAM-D, Hamilton Depression Rating Scale; POMS, Profile of Mood State; CGI, Clinical Global Impression; YBOCS, Yale Brown Obsessive Compulsive Scale; MADRS, Montgomery-Asberg Depression Rating Scale; BDI, Beck Depression Inventory; IDS, Inventory of Depressive Symptoms; IPG, Implanted Pulse Generator; mA, milli-Amps; mcS, micro-seconds.