ANZCTR search results

Mental health (e.g., anxiety, depression) and functional difficulties (e.g., cognitive problems) are highly comorbid in people with Multiple Sclerosis (MS). However, access to effective psychological treatments are limited. People with MS face many barriers (e.g., costs, limited trained clinicians, mobility issues) accessing effective psychological care. Moreover, limited resourcing has meant that specialist mental health and other supportive care has yet to be integrated into neurology settings as has occurred in other areas, such as cancer care. The purpose of this project is to assess the acceptability, feasibility and effectiveness of an established internet-delivered psychological treatment, the Wellbeing Neuro Course, in reducing symptoms of depression, anxiety and disability in patients with Multiple Sclerosis attending the MS Clinic at the Royal North Shore Hospital (MSC-RNSH). The secondary aim is to gather information about the implementation of the Wellbeing Neuro Course into routine care at the MSC-RNSH. It is hypothesised that: (1) the program will be highly acceptable and that high levels of engagement will be observed; (2) the program will require relatively little clinician time to administer; and (3) preliminary evidence of improvements in disability, anxiety, and depression will be observed at post-treatment and maintained at 3-month follow-up in patients with MS.

The efficacy, safety, and tolerability of daily intranasal insulin as a potential treatment for neurocognitive deficits in bipolar disorder (BD) will be investigated in a randomised controlled trial (RCT) across 12 weeks. Neurocognitive deficits are common in BD and can cause significant impairment in everyday functioning. Currently, there are no recommended treatments for neurocognitive deficits in BD, antipsychotics might aggravate cognition and the first line treatment for BD (lithium) has uncertain pro-cognitive effects. Thus, advances in the treatment of neurocognitive deficits in BD are urgently needed. The current study will investigate the efficacy of insulin in improving global neurocognition and psychosocial functioning in people with BD. The safety and adherence of the treatment will also be assessed. This novel clinical trial has the potential to be transformational for people with BD given the critical need to improve neurocognition and psychosocial functioning in those who experience it.

The purpose of this project is to investigate the effect of a 6-month personalised lifestyle protocol that incorporates recommendations from the ph360/Shae platform and phone app (nutrition, exercise, sleep, mindset, relationships, environment) and group coaching on the change in markers of diabetes and pre-diabetes. It is hypothesised that the personalised intervention using Shae will result in greater overall improvement in markers relating to Type 2 Diabetes. If the results are confirmatory, this study will contribute to an evidence-based rationale for personalising lifestyle medicine interventions for the care of type 2 diabetes.

This is a phase I, open-label, dose-escalation, multiple-dose study to investigate pharmacokinetics and safety of JT001 in Caucasian healthy subjects. The study consists of three dose level (200, 400, 600 mg). and the participant will be sequentially assigned from low-dose group to high-dose group to receive the JT001 at one of the three doses according to the dose escalation scheme. The total duration of participants in the study will be of 14 to 26 days. The study includes a screening phase (up to 14 days), a 6-day multiple-dose phase (D1-D6), a 3-day safety observation phase (end of administration) and 4-day safety follow up period. Total approximately 27 participants will be enrolled in the study. Each group of dose level will enroll approximately 9 participants. Oversight of the study will be provided by a committee (the Safety Review Committee) comprising a representative of the Sponsor or Sponsor’s designee, the investigator, and the medical monitor.

The study aims to evaluate the effectiveness of Gaming Habit Hacker, which is an internet-delivered intervention for people who want to reduce time spent gaming. Gaming Habit Hacker offers an innovative 28-day program to develop new habits that can support gaming reduction. Gaming Habit Hacker is informed by the Health Action Process Approach and implementation intentions literature and delivered in accordance with Self-determination Theory. Eligible participants will be randomised to the intervention group or comparison group. The intervention group will receive Gaming Habit Hacker, which delivers feedback on assessment, goal setting, action and coping planning, and feedback on outcomes of behaviour. The comparison group will receive assessment only. Participants will complete the baseline, 4-week post intervention, and 26-week follow-up evaluation surveys.

Aims • To quantitatively describe details of normal lumbar interspinous ligament and interlaminar foramen anatomy. • To define features that may influence needle access to the neuraxis. Hypotheses • The anterior lumbar interspinous ligament may be bilaminar with a gap corresponding to a midline gap between the opposing leaves of the ligamentum flavum. • An anterior midline gap in the lumbar interspinous ligament contains fat. • The lumbar interspinous ligament may have structural gaps not related to the ligamentum flavum. • The gaps may have a size equivalent to an epidural needle orifice. Objectives • Derive morphometric data of posterior lumbar structures of normal adult volunteers using high-definition magnetic resonance and ultrasound imaging. • Present quantitative description of normal posterior lumbar structures in a manner directly applicable to the midline passage of a needle into the neuraxis. Methods Recruit normal adult volunteers. Record demographic data then generate and record measurements pertaining to their lumbar spine using clinical examination, ultrasound scanning and high-definition magnetic resonance imaging. Generate descriptive statistical results, compare equivalent measurements derived from the different modalities, and describe in detail anatomical midline and adjacent features that may be sensed during needle passage to the neuraxis.

We propose that i) collection of sufficient cord blood will be feasible in infants with antenatally diagnosed fetal stroke, and ii) (multiple) autologous intravenous administration of processed umbilical cord blood derived cells in these infants in the newborn period will be safe. This phase I trial will be the first study in the translational pipeline for this neurological condition, and will test the feasibility of cord blood collection, sufficient cell availability and safety of cell administration in this vulnerable group. Following successful completion of this study, an efficacy trial will be planned to determine the efficacy of autologous UCB cell administration in fetal stroke.

The purpose of the project is to examine if caloric vestibular stimulation improves symptoms of persistent pain in phantom limb pain, spinal cord injury pain, complex regional pain syndrome and non-specific persistent pain. The CVS technique is a simple, non-invasive procedure that involves irrigating the ear with iced water. The comparator condition is a cold-arousal control involving an ice-pack placed on the forehead. The hypothesis is that CVS, but not the control ice-pack condition, will treat persistent pain. If the study is successful, the technique could be important as a treatment for managing persistent pain in people who have tried other treatments that have not worked or have caused side-effects, or as a non-invasive alternative treatment to current treatments. The results may also have particular importance for treatment in the developing world, where medication and other therapies are often unavailable.

This trial aims to monitor and manage the workloads of adolescent athletes that participate in ARF or Soccer while observing the effects of these workloads on neuromuscular function and wellbeing. Using a parallel-group study design, we aim to investigate the effects that a periodised training program has on the physical performance, fatigue levels, and wellbeing of adolescent athletes attending Launceston Church Grammar School (Intervention group), compared to a Control group following their usual training programs. The findings of this research could be used to improve the periodisation of training programs for adolescent ARF or Soccer players and assist the development and transitioning of these adolescent athletes into elite adult ARF or Soccer athletes. Furthermore, the findings may assist in monitoring and managing future workloads of adolescent ARF or Soccer athletes through accurately altering weekly or daily training loads to ensure a safe workload ratio is maintained to maximise physiological adaptation. We hypothesise that participants following the periodised training program (intervention group) will display greater improvements in physical performance, reduced neuromuscular fatigue, and improved wellbeing compared to participants following their own training program (control group).

This study will assess the implementation and impact of a Community Health Navigator (CHN) delivered model of care that will specifically support the transition of care from hospital to the community for patients who have a chronic health condition, including cancer. Who is it for? You may be eligible for this study if you are aged 40 or older, you have been admitted to any of the Royal Prince Alfred, Concord, Balmain, and Canterbury hospitals for a chronic condition (including cancer), or you have been admitted under the aged care service. Study details Participants who choose to enroll in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants in the first group will be given access to the Community Health Navigator program which will involve at least two home visits by Community Health Navigators to assess problems, provide non-clinical support and assist in navigation to other services as required. The second group will receive usual care and will not be included in the CHN program at this time. It is hoped this research will demonstrate that the CHN program is practical to deliver to patients with chronic health conditions (including cancer), and that the CHN program has a positive impact upon the care provided to these patients which may result in fewer hospital admissions.