Table 4 Anticipated adverse events at 10 weeks as measured using the tDCS Adverse Events Questionnaire39

From: Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial

 

Active (n = 87)

Sham (n = 86)

 

Adverse event category

Total

Mild

Moderate

Severe

Total

Mild

Moderate

Severe

P

Headache

36 (42.4)

24 (28.2)

11 (12.9)

1 (1.2)

29 (35.8)

18 (22.2)

9 (11.1)

2 (2.5)

0.43

Neck pain

2 (2.4)

0 (0)

2 (2.4)

0 (0)

4 (4.9)

1 (1.2)

3 (3.7)

0 (0)

0.44

Scalp pain

18 (21.2)

14 (16.5)

3 (3.5)

1 (1.2)

10 (12.3)

7 (8.6)

3 (3.7)

0 (0)

0.15

Itching

43 (50.6)

37 (43.5)

3 (3.5)

3 (3.5)

35 (43.2)

28 (34.6)

7 (8.6)

0 (0)

0.08

Burning sensation

37 (43.5)

32 (37.6)

4 (4.7)

1 (1.2)

31 (38.3)

25 (30.9)

6 (7.4)

0 (0)

0.43

Skin redness

54 (63.5)

42 (49.4)

11 (12.9)

1 (1.2)

15 (18.5)

13 (16.0)

2 (2.5%)

0 (0)

<0.001*

Sleepiness

10 (11.8)

5 (5.9)

4 (4.7)

1 (1.2)

12 (14.8)

9 (11.1)

2 (2.5)

1 (1.1)

0.65

Trouble concentrating

12 (14.1)

8 (9.4)

3 (3.5)

1 (1.2)

3 (3.7)

2 (2.5)

1 (1.2)

0 (0)

0.03

Acute mood change

7 (8.2)

3 (3.5)

3 (3.5)

1 (1.2)

6 (7.4)

5 (6.2)

1 (1.2)

0 (0)

1.00

  1. Data are n (%). An adverse event was present if the participant rated that it was at least remotely possible that it was associated with the intervention. Participants rated the severity of the adverse events as mild, moderate or severe. P values, determined with a two-sided Fisher’s exact test, represent the group differences of the total number of events per event category. *Exact P value for skin redness (0.000000003).
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