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Posted On: 06/19/2024 3:33:01 AM
Post# of 148863
A high level of exclusions like this makes me wonder about the credibility of the study. For instance - "participants who did not have a sufficient T1w image quality, including excessive motion artifact and insufficient gray matter-white matter contrast". The image quality should have been noticeable immediately and could have been redone. That they waited to exclude after the trial ended could mean they were actually excluded based on failure of treatment. This is the possible shenanigans you look out for when looking at trial results.
Quote:
Analyses were conducted on all OVERTURE participants who met none of the exclusion criteria: The exclusion criteria for white matter volumetric analyses were as follows: (a) participants who declined > 4 standard deviations from the mean in multiple efficacy measures (1 sham participant excluded); (b) participants who did not have both baseline and end of study (i.e., Month 6) data for structural MRI (22 participants excluded, of which 21 of them did not complete the trial); (c) participants who did not have a sufficient T1w image quality, including excessive motion artifact and insufficient gray matter-white matter contrast (13 participants excluded). Overall, thirty-eight participants (25 Treatment and 13 Sham) were included in white matter volumetric assessments. Of the thirty-eight participants, two failed T2w image quality due to reconstruction error, and a total of thirty-six participants (24 Treatment and 12 Sham) were included for longitudinal T1w/T2w white matter myelin content assessments. Noninvasive Gamma Sensory Stimulation May Reduce White Matter and Myelin Loss in Alzheimer’s Disease
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