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. 2020 Sep 14;3(9):e2017337. doi: 10.1001/jamanetworkopen.2020.17337

Table 1. Demographic and Clinical Characteristics of 43 Participants Who Completed the Study.

Parameter No. (%) P value
Total (N = 43) Sham (n = 24) LLLT (n = 19)
Sex
Women 21 (48.8) 12 (50.0) 9 (47.4) .864
Men 22 (51.2) 12 (50.0) 10 (52.6)
Age, mean (SD), y 50.49 (17.44) 54.00 (14.68) 46.05 (19.93) .14
Injury mechanism
Bike/motorcycle accident .10
With helmet 4 (9.3) 4 (16.7) 0
Without helmet 1 (2.3) 0 1 (5.3)
Fall 25 (58.1) 14 (58.3) 11 (57.9)
Other 1 (2.3) 1 (4.2) 0
Pedestrian accident with car/motorcycle/bike 4 (9.3) 3 (12.5) 1 (5.3)
Car crash
Restrained 3 (7.0) 0 3 (15.8)
Unrestrained 1 (2.3) 1 (4.2) 0
Violence/assault 4 (9.3) 1 (4.2) 3 (15.8)
History
Hypertension 15 (34.9) 9 (37.5) 6 (31.6) .69
Diabetes (type 1 or 2) 7 (16.3) 4 (16.7) 3 (15.8) .94
Imaging findings
Hemorrhage
Extracranial 18 (41.9) 10 (41.7) 8 (42.1) .98
Epidural 2 (4.7) 0 2 (10.5) .10
Acute subdural 13 (30.2) 9 (37.5) 4 (21.1) .24
Subarachnoid 19 (44.2) 13 (54.2) 6 (31.6) .14
Edema 1 (2.3) 1 (4.2) 0 (0.0) .37
Contusion 4 (9.3) 2 (8.3) 2 (10.5) .81
Hemorrhage
Intraparenchymal 7 (16.3) 3 (12.5) 4 (21.1) .45
Intraventricular 1 (2.3) 0 (0.0) 1 (5.3) .26
Skull fracture 10 (23.3) 6 (25.0) 4 (21.1) .76
Intracranial air 2 (4.7) 1 (4.2) 1 (5.3) .87
Facial fracture 12 (27.9) 8 (33.3) 4 (21.1) .38
Orbital injury 5 (11.6) 3 (12.5) 2 (10.5) .84
Fazekas scalea
Periventricular white matter hyperdensities
Absent (0) / caps or pencil-thin lining (1) 37 (86.0) 19 (79.2) 18 (94.7) .44
Smooth halo (2) 4 (9.3) 3 (12.5) 1 (5.3)
Irregular periventricular signal extending into the deep white matter (3) 1 (2.3) 1 (4.2) 0
Deep white matter hyperdensities
Absent (0) / punctate foci (1) 35 (81.4) 19 (79.2) 16 (84.2) .64
Beginning confluence (2) 6 (14.0) 3 (12.5) 3 (15.8)
Large confluent areas (3) 1 (2.3) 1 (4.2) 0
Antiepileptic drug prophylaxis 24 (55.8) 14 (58.3) 10 (52.6) .71
Therapy
Physical 19 (44.2) 13 (54.2) 6 (31.6) .14
Occupational 13 (30.2) 8 (33.3) 5 (26.3) .62
Speech 5 (11.6) 4 (16.7) 1 (5.3) .25
Rehabilitation 3 (7.0) 3 (12.5) 0 .11
ICU stay 3 (7.0) 3 (12.5) 0 .11
RPQ scores, mean (SD)b
RPQ-3 4.28 (3.13) 4.55 (3.13) 3.94 (3.19) .56
RPQ-13 11.92 (8.71) 12.64 (7.83) 10.94 (9.98) .56
RPQ-Total 16.21 (10.83) 17.18 (10.01) 14.88 (12.08) .53

Abbreviations: LLLT, low-level light therapy; RPQ, Rivermead Post-Concussion Questionnaire.

a

The Fazekas scale is split into periventricular and deep white matter, and the score ranges from 0 (no disease) to 3 (the most severe disease).

b

The RPQ is a 16-item self-assessment questionnaire. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) to 4 (severe problem). RPQ-3 assessment includes early, objective, and physical symptoms of TBI; RPQ-13 assessment includes later, more cognitive and behavioral symptoms.