Trial Outcomes & Findings for Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury (NCT NCT02158494)

13 subjects provided consent but did not enroll in the study at sites under UW-Madison purview.

Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury

SOT assesses the ability to use visual, proprioceptive, and vestibular cues to maintain postural stability. Subjects stand on dual-force plates and the anterior-posterior sway is recorded. 6 conditions are tested (3, 20-sec trials each): Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual surround; Eyes open on sway referenced support surface; Eyes closed on sway referenced support surface; Eyes open on sway referenced support surface and surround. A composite score is generated by the NeuroCom BalanceMaster System using an algorithm to calculate the composite score from each of the 3 serial repetitions for each of the 6 conditions (a total of 18 sub-scores). The calculated composite score ranges from 0 to 100 points; 0 is complete failure, 100 is perfect stability, 70 is the lower limit normal. Group mean score for each time-point is reported.

A 22-item subjective inventory of TBI symptoms where symptoms are scored on a scale of 0 (none) to 4 (very severe). Lower scores indicate decreased symptoms. Group mean change from baseline at 2, 14, and 26 weeks is reported. The range of possible scores if from 0 to 88. The results are reported as a change from baseline.

Measures walking speed over ground. The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. Change in 6MWT over baseline for each time point is reported.

Assesses walking, walking with head turns, over and around obstacles, and stairs. Dynamic Gait Index - A semiquantitative tool used to evaluate a patient's ability to modify gait by changing task demands, esp. in patients with dizziness and balance deficits. This test is used to identify patients, esp. older adults, who are predisposed to falling. Participants are graded from 0 (low function) to 3 (high function) on 8 tasks: normal walking, their ability to vary walking speed, turn their heads, turn their bodies, step over and around obstacles, climb stairs, turn while walking. The range of scores is 0-24, higher scores indicate higher function, with a score of 24 considered Normal. Change from baseline to 2, 14, and 26 weeks is reported.

Assesses short- and long-term verbal memory by evaluating a series of recall and recognition tasks. The test is scored via computer algorithm. A score of 50 represents is equal to the population mean, the normal range is between 40-60 (ie. +/- 1 SD from the mean). The total range of possible scores is 0 (no recalled words) to 100 (all correct). Change in score over baseline at 2, 14, and 26 weeks is reported.

A short, reliable, 18-question instrument for assessment of psychological distress (anxiety, depression, \& somatization) in a clinical population. It is scored from 0-4, with a total range of possible scores 0-72 where higher scores indicate more distress.

Assesses visual spatial abilities. The Symbol Search and Coding WAIS-IV subtests measure Processing Speed, an indicator of the rate of cognitive processing and creating an appropriate response output. The tasks require attending to visual material, visual scanning and perception, spatial organization, hand-eye coordination, and paired associative learning. The raw score (processing speed for each test) is converted to a scaled score 1-10 for each and summed for a total possible score of 2-20, the higher the score, the more improved the processing speed. Change in score from baseline to 2, 14, and 26 weeks are reported.

Subjective inventory of sleep habits, duration and quality. It is scored from 7 components (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) to provide a global PSQI score. Most items are scored from 0-3 where 3 is a negative extreme, therefore lower cumulative scores are indicative of improved sleep habits. The total range of scores is from 0-21.

Assesses frequency \& severity of headaches via a 25-item questionnaire where an answer of 'yes' = 4 points, 'sometimes' = 2 points, and 'no' = 0 points. The lower the score, the less frequent and severe the symptoms. The range of possible scores is 0 to 100. The results are reported as a change from baseline.

Measures muscle activation patterns during gait.

Measures eye movement control under 3 static (x and y axis fixation, spontaneous nystagmus), and 3 dynamic conditions (random saccade, smooth pursuit, optokinetic nystagmus).