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Introduction Current: evidence suggests that the loss of mechanoreceptors after anterior cruciate ligament (ACL) tears might be compensated by increased cortical motor planning. This occupation of cerebral resources may limit the potential to quickly adapt movements to unforeseen external stimuli in the athletic environment. To date, studies investigating such neural alterations during movement focused on simple, anticipated tasks with low ecological validity. This trial, therefore, aims to investigate the cortical and biomechanical processes associated with more sport-related and injury-related movements in ACL-reconstructed individuals.
Methods and analysis: ACL-reconstructed participants and uninjured controls will perform repetitive countermovement jumps with single leg landings. Two different conditions are to be completed: anticipated (n=35) versus unanticipated (n=35) successful landings. Under the anticipated condition, participants receive the visual information depicting the requested landing leg prior to the jump. In the unanticipated condition, this information will be provided only about 400 msec prior to landing. Neural correlates of motor planning will be measured using electroencephalography. In detail, movement-related cortical potentials, frequency spectral power and functional connectivity will be assessed. Biomechanical landing quality will be captured via a capacitive force plate. Calculated parameters encompass time to stabilisation, vertical peak ground reaction force, and centre of pressure path length. Potential systematic differences between ACL-reconstructed individuals and controls will be identified in dependence of jumping condition (anticipated/ unanticipated, injured/uninjured leg and controls) by using interference statistics. Potential associations between the cortical and biomechanical measures will be calculated by means of correlation analysis. In case of statistical significance (α<0.05.) further confounders (cofactors) will be considered.
Ethics and dissemination: The independent Ethics Committee of the University of Frankfurt (Faculty of Psychology and Sports Sciences) approved the study. Publications in peer-reviewed journals are planned. The findings will be presented at scientific conferences.
Trial status: At the time of submission of this manuscript, recruitment is ongoing.
Trial registration number: NCT03336060; Pre-results.
Availability of novel psychoactive substances (NPS) exponentially increased over the last years. Risk evaluations of NPS are hampered by the lack of pharmacological studies in humans on health parameters. The aim of the present study was to evaluate safety and neurocognitive function of healthy volunteers (N = 12) who received single doses of 100 and 150 mg 4-fluoroamphetamine (4-FA), a phenethylamine that has been associated with severe cardiovascular and cerebrovascular complications. The study was set-up as a placebo controlled, within subject, phase 1 trial as it was the first to administer 4-FA to humans under controlled conditions. Overall, 4-FA produced a strong elevation in blood pressure up until 4-5 h after administration that was followed by a sustained increase in heart rate. After an interim review of safety data from five participants, a decision was taken to cancel administration of 150 mg. We subsequently obtained complete datasets for placebo and 100 mg 4-FA treatments only. Effects of 4-FA on mood and neurocognitive function were most distinct at 1 h post drug and included significant elevations of vigor, friendliness, elation, arousal, positive mood, as well as improvements in attention and motor performance. Negative affect was also reported as time progressed in the acute phase and even more so during the subacute phase. Overall, the influence of 4-FA on vital signs, mood, and neurocognition was similar to that observed with other stimulants. Present findings confirm clinical observations of acute toxicity among 4-FA users and warrant warnings about potential health risks associated with 4-FA use.