Table 15:
Adverse Effects Reported in Studies of MRgFUS Ventral Intermediate Nucleus Thalamotomy
| Author, Year (n) | Time Point | Paresthesias or Numbness, n (%) | Gait or Motor Disturbance, n (%) | Speech Problems, n (%) | Headache, n (%) | Vestibular Issues, n (%) | Other, n (%) |
|---|---|---|---|---|---|---|---|
| Elias et al, 201638,a | Totalb | Face and hand, 6 (11) | Ataxia, 11 (20) | Dysarthria, 1 (2) | > 1 day, 8 (14) | Disequilibrium sensation, 5 (9) | Contralateral weakness, 2 (4) |
| Randomized to MRgFUS (n = 56) | Face, lips, and tongue, 8 (14) Hand and fingers, 6 (11) Leg, 1 (2) |
Subjective unsteadiness, 9 (16) Dysmetria, 7 (12) |
Dysphagia, 1 (2) | Tinnitus, 3 (5) | Fatigue, 3 (5) Taste disturbance, 3 (5) |
||
| 12 mo | Face and hand, 8 (14) Face, lips, and tongue, 5 (9) Hand and fingers, 2 (4) Leg, 0 |
Ataxia, 2 (4) Subjective unsteadiness, 3 (5) Dysmetria, 2 (4) |
Dysarthria, 0 Dysphagia, 0 |
— | Disequilibrium sensation, 1 (2) Tinnitus, 0 |
Contralateral weakness, 1 (2) Fatigue, 0 Taste disturbance, 2 (4) |
|
| Elias et al, 201638,b Unblinded crossover cohort (n = 21) |
Totalc | Face, lips, and tongue, 6 (29) Hand and fingers, 5 (24) |
Ataxia, 3 (14) Subjective unsteadiness, 5 (24) Dysmetria, 3 (14) |
Dysarthria, 3 (14) | Any, 7 (33) | Disequilibrium sensation, 3 (14) | Contralateral weakness, 3 (14) Fatigue, 4 (19) Taste disturbance, 2 (10) |
| 12 mo | Face, lips, and tongue, 5 (24) Hand and fingers, 1 (5) |
Ataxia, 0 Subjective unsteadiness, 1 (5) Dysmetria, 2 (10) |
Dysarthria, 2 (10) | Any, 0 | Disequilibrium sensation, 1 (5) | Contralateral weakness, 1 (5) Fatigue, 0 Taste disturbance, 2 (10) |
|
| Chang et al, 201536 (n = 11) | 1 mo | – | – | – | – | Mild balance problem, 1 (9) | – |
| Elias et al, 201337 (n = 15) | Postoperative | Lip or tongue, 9 (60) Finger, 5 (33) |
Ataxia, 4 (27) Subjective unsteadiness, 5 (33) Dysmetria, 1 (7) |
Slurred speech (dysarthria), 1 (7) | – | – | Weak grip, 1 (7) |
| 12 mo | Lip or tongue, 2 (13) Finger, 1 (7) |
Ataxia, 0 Subjective unsteadiness, 0 Dysmetria 0 |
Slurred speech (dysarthria), 0 | > 1 day, 0 | – | Weak grip, 0 | |
| Lipsman et al, 201341 (n = 4) | 3 mo | Thumb and index finger, 1 (20) | – | – | – | – | – |
Abbreviation: MRgFUS, magnetic resonance-guided focused ultrasound.
Note: The adverse effects described include all those as reported in the published articles.
a
The events reported are those occurring in the MRgFUS arm of the randomized controlled trial. Events at 12 months persist.
b
The events reported are those occurring in the unblinded cohort of crossover participants from the sham arm. Events at 12 months persist.
c
The total reflects the sum of all events occurring any time during the 3-month randomized study period.