Active clinical trials for "Brain Injuries"

Factors related to successful rehabilitation in acquired brain injury (ABI) are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Regarding salience, patients may lose interest or find a traditional intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for patients but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Additionally, the same factors that are related to can impact adherence are also related to neuroplasticity. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes for those with ABI. The gamification of rehabilitation therapies using augmented reality (AR) may help promote adherence. Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the experience achieved through AR can further promote salience and be customizable to individual patient requirements. As AR systems are now highly portable, cost-effective, and relatively simple to utilize, they can provide an excellent opportunity to provide more engaging rehabilitation approaches compared to standard care alone. AR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose AR-delivered ABI program (developed by the Cognitive Projections Lab, University of Alberta) has been created in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with ABI rehabilitation therapy. The proposed studies are to investigate the feasibility of implementing this technology alongside routine clinical care, obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose AR ABI-therapies on patient adherence and clinical outcomes, compared to traditional clinical care alone.

Fatigue is a common, persistent consequence of acquired brain injury (ABI). Research into treatments that may alleviate post-ABI fatigue is been limited. Pharmacological treatment (methylphenidate) has shown the greatest scientific effects, but is complicated because the risk of adverse side effects and its potential for abuse. COGRAT, an evidence-based treatment combining cognitive therapy (CO) with graded activity training (GRAT), is found to be effective in treating fatigue in patients with acquired brain injury. However, therapist guided internet-based CBT (I-CBT) could offer a more accessible and cheaper alternative to this highly frequent face to face treatment. Moreover, I-CBT is found to be effective in a population with patients with psychiatric and chronic somatic disorders, including chronic fatigue syndrome. Recent studies suggests that I-CBT is effective for people with ABI as well. To obtain optimal benefit from both group delivered face to face therapy and e-health and to combine the available evidence of COGRAT and I-CBT in patients with ABI, we developed a blended e-health cognitive behavioral (group)intervention; e-COGRAT. The goal of this intervention study is to evaluate the efficacy and feasibility of e-COGRAT to treat fatigue in people with ABI. The main questions it aims to answer are: Is a blended eHealth cognitive behavioral (group)intervention (e-COGRAT) effective as a treatment for fatigue in people with ABI? Is e-COGRAT the blended care variant of COGRAT, a cognitive behavioral group treatment for fatigue afer ABI, comparable to COGRAT in terms of efficacy? Will participants of e-COGRAT improve significant on overall fatigue, emotional well-being and participation? Will it be feasible for at least 80% of the participants to complete the intervention completely?

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to central neuropathy of any genesis. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to central neuropathy of any genesis.

The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.

A non-randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.

Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ameliorate the consequences of TBI. Sildenafil potentiates nitric oxide (NO) dependent vasodilatation and is approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction and primary pulmonary hypertension. In pre-clinical models of stroke, sildenafil improves cerebral blood flow (CBF), promotes, angiogenesis, neurogenesis and improves recovery. In an initial Phase 2a trial (NCT01762475) of sildenafil in patients with chronic moderate to severe TBI, the investigators found that low dose sildenafil (25 mg BID) therapy is safe and well tolerated, that a single dose of sildenafil 50 mg potentiates CVR in areas of the brain with dysfunctional endothelium, and that CVR is a reliable diagnostic marker of TCVI and has potential as a pharmacodynamic and predictive biomarker. In this proposal, the investigators will conduct a randomized clinical trial to determine the optimal PDE5 inhibitor dose to improve or normalize microvascular function (as measured by the change in CVR measurements before and after a single dose of sildenafil, or ΔCVR) using a range of sildenafil citrate doses: 20, 40, 80 mg) in chronic TBI patients. The investigators will also test the safety and tolerability of the same dose ranges of chronic (4-week) thrice daily sildenafil or placebo administration in chronic TBI patients and explore its effects on chronic symptoms and clinical outcomes.

This study first aims to validate the feasibility of a multimodal 5-day 20-minute tACS protocol in subacute brain-injured patients with a disorder of consciousness during their ICU stay, and conduct a clinical pilot study (validation phase). Upon completion of this validation phase and according to obtained results, a randomized clinical trial will be conducted to compare the effects of the 5-day active 10Hz-tACS protocol with a 5-day sham-tACS protocol on brain dynamics modulation. This study will also compare intervention conditions on recovery of consciousness, cognition and function using short-term and long-term measurements.

The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.

The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries. The researchers will be using an investigational system of devices to non-invasively (that, is, without penetrating the skin), measure the amount of oxygen going to and being used by the brain. They will be taking some bedside research measurements during the babies' stay at the hospital. With these measurements, the intention is to study the role of oxygen in brain injury and test the efficacy of the research device and its potential as a permanent bedside diagnostic device.

Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life. Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of infants. Their incidence is inversely proportional to gestational age (GA) and birth weight (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance, visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic hemodynamics during transition from intra- to extra-uterine life and during the early neonatal period is believed to be at their genesis. While the incidence of ultrasound- diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity and brain volume and eventual neurocognitive impairment. Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has remained relatively stable. Once translated to the bedside, the goal of this research is to develop a monitoring system that will allow researchers to identify infants most at risk for IVH and PVL and in the future, intervention studies will be initiated to use the changes in cerebral perfusion to direct hemodynamic management. The purpose of this study is to first understand the physiology of brain injury and then to eventually impact the outcomes in this high-risk group of infants by assessing the ability of the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for this study will help develop algorithms or monitoring plans that will maintain the appropriate brain perfusion pressure and thereby, prevent severe brain injury.