Table 3.
Side effects during Study 1 and Study 2
| Study 1 | Study 2 | ||||
|---|---|---|---|---|---|
|
| |||||
| Sham | Active | Sham | Active | ||
| Scalp Burn | Absent | 11 (92%) | 9 (60%) | 11 (92%) | 12 (80%) |
| Present | 1 (8%) | 6 (40%) | 1 (8%) | 3 (20%) | |
|
| |||||
| Tingling | Absent | 12 (100%) | 12 (80%) | 12 (100%) | 14 (93%) |
| Present | 0 (0%) | 3 (20%) | 0 (0%) | 1 (7%) | |
|
| |||||
| Skin Redness | Absent | 12 (100%) | 6 (40%) | 11 (92%) | 6 (40%) |
| Present | 0 (0%) | 9 (60%)* | 1 (8%) | 9 (60%)* | |
|
| |||||
| Sleepiness | Absent | 11 (92%) | 11 (79%) | 12 (100%) | 12 (80%) |
| Present | 1 (8%) | 3 (21%) | 0 (0%) | 3 (20%) | |
|
| |||||
| Trouble Concentrating | Absent | 12 (100%) | 15 (100%) | 12 (100%) | 14 (93%) |
| Present | 0 (0%) | 0 (0%) | 0 (0%) | 1 (7%) | |
|
| |||||
| Mood Change | Absent | 11 (92%) | 15 (100%) | 12 (100%) | 15 (100%) |
| Present | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) | |
|
| |||||
| Headache | Absent | 12 (100%) | 15 (100%) | 12 (100%) | 15 (100%) |
| Present | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
|
| |||||
| Neck pain | Absent | 12 (100%) | 15 (100%) | 12 (100%) | 15 (100%) |
| Present | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
|
| |||||
| Scalp Pain | Absent | 12 (100%) | 15 (100%) | 12 (100%) | 15 (100%) |
| Present | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
|
| |||||
| Trouble concentrating | Absent | 12 (100%) | 15 (100%) | 14 (93%) | 14 (93%) |
| Present | 0 (0%) | 0 (0%) | 1 (7%) | 1 (7%) | |
Data reported as the total number of side effects reported during the three days of stimulation.
The active group had a higher prevalence of skin redness at both visits as compared to the sham group (60% vs. 4%, Fischer’s Exact Test, 0 < 0.05).
Symptoms are listed exactly as asked on the questionnaire and thus reflected the subjects’ subjective interpretation. True “burns” were not observed by the investigators.