Table 17:
Adverse Effects Reported Over 3 Months in a Randomized Controlled Trial of MRgFUS Thalamotomy Versus Sham
| Adverse Effect | MRgFUS (N = 56), Totala n (%) | Sham (N = 20), Totala n (%) |
|---|---|---|
| Procedural Events | ||
| Head discomfort | 17 (30) | 0 |
| Stereotactic frame pin-site edema, pain, or bruising | 17 (30) | 7 (35) |
| Vertigo | 12 (21) | 0 |
| Nausea | 11 (20) | 2 (10) |
| Back pain | 5 (9) | 1 (5) |
| Scalp tingling | 4 (7) | 1 (5) |
| Anxiety | 3 (5) | 2 (10) |
| Vomiting | 2 (4) | 0 |
| Paresthesias or Numbness | ||
| Face, lips, and tongue | 8 (14) | 0 |
| Face and hand | 6 (11) | 0 |
| Hand and fingers | 6 (11) | 1 (5) |
| Leg | 1 (2) | 0 |
| Gait or Motor Disturbance | ||
| Ataxia | 11 (20) | 0 |
| Subjective unsteadiness | 9 (16) | 1 (5) |
| Dysmetria | 7 (12) | 0 |
| Speech Problems | ||
| Dysarthria | 1 (2) | 0 |
| Dysphagia | 1 (2) | 0 |
| Vestibular Symptoms | ||
| Disequilibrium sensation | 5 (9) | 0 |
| Tinnitus | 3 (5) | 0 |
| Other Effects | ||
| Headache lasting more than 1 day | 8 (14) | 4 (20) |
| Fatigue | 3 (5) | 1 (5) |
| Taste disturbance | 3 (5) | 0 |
| Contralateral weakness | 2 (4) | 0 |
Abbreviations: MRgFUS, magnetic resonance-guided focused ultrasound; N, number of participants in the group; n, number of events reported.
a
The total reflects the sum of all events occurring any time during the 3-month randomized study period.
Source: Elias et al, 2016.38