Tempe, AZ Paid Clinical Trials

Patients with hearing loss who use cochlear implants (CIs) show significant deficits and strong unexplained intersubject variability in their perception and production of spoken emotions in speech. This project will investigate the hypothesis that "cue-weighting", or how patients utilize the different acoustic cues to emotion, accounts for significant variance in emotional communication with CIs. The results will focus on children with CIs, but parallel measures in postlingually deaf adults with CIs will be made, ensuring that results of these studies benefit social communication by CI patients across the lifespan by informing the development of technological innovations and improved clinical protocols. Read Less

The goal of this clinical trial is to test the effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in improving arm function after a stroke. The main questions it aims to answer are 1) Does startle rehabilitation therapy improve functional arm performance after training on a specific task and 2) Can training benefits, if any, be seen in other untrained tasks? Researchers will enroll participants across a wide range of upper extremity impairments post-stroke. Participants will be enrolled in three consecutive days of in-person training on an upper extremity task followed by a single-day follow-up session one month after training is completed. Each training session will last for approximately 3 hours per day. Participants will be randomly assigned to one of two groups; 1) Arm training with START and 2) Arm training without START. Study participants and assessors will be blinded to the type of training received. Before the training, participants will be clinically assessed to determine impairment level. During training, participants will be asked to perform; 1) a simulated feed task which involves transferring kidney beans using a spoon from one cup (start position) to another cup (end position) in front of them OR 2) A functional reaching task where participants will maintain a tool (spoon) in their hand while extending their arm forward towards an end position based on the severity of arm impairment as determined by the clinical assessment. Researchers will compare the % change in trained task scores, muscle activity, and arm movement outcome measures at three-time points; baseline on day 1, at the end of training on day 3, and one month after training. Read Less

A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint. Read Less

The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and then analyze patient EEG data. Read Less

This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery. Read Less

Individuals with low socioeconomic status (SES) are more likely to have a stroke, more disabled at 3 months, and less likely to be independently ambulatory. Individuals with low SES struggle to adhere to physician guidelines because of 1) increased disability leaves patients ineligible or unable to tolerate therapy, and 2) poor access to quality care i.e., lack of transportation to therapy. To reduce post-stroke disparity in low SES groups, we need to invest in development of novel tools that make therapy more accessible. For the past 5 years, the PI has been developing Startle Adjuvant Rehabilitation Therapy (START), a tele-enabled, low-cost treatment to improve upper-extremity therapy outcomes in individuals with stroke - in particular individuals with severe-to-moderate stroke. START is the application of a startling, acoustic stimulus (via headphones) which increases the intensity of practice, particularly in severe patient populations. START is adjuvant, meaning it does not replace clinical practice but instead enhances current evidence-based treatments. Objective: we seek to determine if START can be used to enhance functionally relevant movement of the upper extremity. Preliminary data: Individuals with severe-to-moderate disability from a stroke completed a remotely delivered, 3-day training of object manipulation with START. Box and Blocks, which was targeted during training, demonstrated a large increase under START (+47.1%) compared to Control (+3.3%). Modified functional reach was also increased under START (+8.9%) compared to Control (+1.1%). Impairment also decreased under START (Upper-Extremity-Fugl-Meyer: +8.6%) resulting in subject-reported increase in arm function both in quantity (Motor Activity Log: +26.2%) and quality (+20.2%). These results indicate that START can be deployed remotely and may prove a valuable, adjuvant tool to enhance functional upper extremity movement. We propose to perform a Phase 1 clinical trial on a larger cohort of 58 subjects, with a longer, 5-day training with the goal of establishing that START can 1) enhance functional movement of the upper extremity and 2) generate sustainable changes that impact quality of life. Impact: This proposal is significant because it tests a tool that has the potential to directly target the causes leading to disparity of care for individuals with low SES. A third (34%) of 6.5 million people in the U.S. with stroke are on Medicaid or uninsured. Our best evidence-based therapies (e.g., high-intensity, CIMT) and our emerging rehabilitation technologies (e.g., TMS, robotics) are inaccessible to our minority and low SES populations. START addresses disparity because it 1) targets individuals with severe disability, which disproportionally affects low SES and minority groups, and 2) is tele-enabled eliminating transportation which 60% of individuals with low SES report as a barrier to care. If successful, this study will set the stage for larger trials to establish 1) the effectiveness of START to be incorporated into traditional therapy and as well as patient compliance, adherence, and tolerance - particularly in low SES groups. Read Less

A stratified, parallel-group, double-blind, randomized controlled trial of remotely delivered START treatment to individuals with severe-to-moderate stroke (with recruitment focused on individuals with low SES) will be conducted. Subjects and assessors will be blinded to the condition making the experiment double blind. Specifically, subjects will be told that we are exploring a new therapy that using different sounds to improve therapy. Parallel group design will ensure that subjects in the Control group are unaware that their "sounds" are softer than the START group. Trainers may become aware that a loud sound is present thus a unique Assessor will evaluate clinical performance before and after training making the study double-blind. Fifty-four subjects will undergo baseline testing in the laboratory to establish their capacity for functional and expressive speech as well as their self-reported health-related quality of life (power analysis below). Next, subjects will participate in a high-frequency, word-picture verification/ auditory-repetition treatment, 2 hr/day for 5 consecutive days focusing on expression of words of functional significance (e.g., water, fall). Subjects will either receive training with START or without (Control). Subjects will be re-tested immediately following training as well as one-month post to assess retention. Aim 1 will evaluate capacity of START to enhance SLT outcomes by assessing the % change in clinical assessment of functional and expressive speech. Our preliminary data points to a robust response [details]. Aim 2 will focus on the capacity of these changes to 1) be retained and 2) impact subject's reported quality of life. NOTE: While we are planning in-person baseline, end, and retention testing, in response to COVID, we have established remote clinical screening using peer-reviewed validated techniques for WAB and ABA-2 (see Alternative Solutions). All preliminary data collected for this proposal were collected remotely via no-contact protocols. Read Less