The objective is to determine if continuous use of TheraBracelet in the home has a clinically meaningful effect in chronic stroke survivors. The study design is a double-blinded randomized controlled trial. We will enroll 40 chronic stroke survivors with moderate hand impairment. Subjects will be randomly assigned to the treatment or control group (n=20 per group). All subjects will wear the TheraBracelet device on the paretic wrist for 8 hours/day every day during their normal daily activity for 1 month. The device will deliver vibration (treatment) or no vibration (control). Double-blinding is possible because the treatment vibration is imperceptible (i.e., subthreshold). Measures of neural plasticity, the amount of the paretic arm use in daily living, clinical hand function, biomechanical grip control, and self-reported abilities for activities of daily living will be assessed at baseline, once a week during the month of wearing the device, and for 3-month follow-up, allowing determination of the efficacy and persistence.
The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection. Placebo means it doesn't contain botulinum toxin type A.
If you are eligible and choose to be in the study, the dose of study drug you receive will depend on the group that you will be put into after randomization at the time of your entry.
You will be assigned, by chance, to 1 of the 3 groups below:
? Group 1: High-dose (250 Units of daxibotulinumtoxinA for injection)
? Group 2: Low-dose (125 Units of daxibotulinumtoxinA for injection)
? Group 3: Placebo (a substance that looks like daxibotulinumtoxinA for injection but has no drug in it)
Study lasts aproximately 39 weeks, including 3 weeks of screening. You will come to the study center up to 12 times during the research study.
The study is being done at approximately 80 sites. Approximately 300 people will take part study-wide and 4 will take part at this institution.
Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with motor deficits, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how tDCS affects motor areas in the brain. We propose using tDCS while recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. We expect this novel approach to broaden our understanding of tDCS application and possibly lead to therapeutic advances in this population.
Transcranial magnetic stimulation (TMS) is often used to assess the excitability of the brain and the connectivity between the brain and peripheral muscles. However, less work has been completed with the portion of the brain controlling leg muscles. In addition, there appears to be more error and less reliability in these measures in those with stroke. This project aims to assess a battery of TMS-derived outcome measures to determine the most effective for those after stroke. This information is of critical importance as we use this technology to assess changes after rehabilitation post stroke and to understand the motor control of walking after neurologic injury.
Rehabilitation interventions including resistance training, functional and task-specific therapy, and gait or locomotor training have been shown to be successful in improving motor function in individuals with neurologic disease or injury. Recent investigations conducted in our laboratory indicate that intense resistance training coupled with task-specific functional training lead to significant gains in functional motor recovery. Similarly, gait rehabilitation involving intense treadmill training and/or task-specific locomotor training has been shown to be effective in improving locomotor ability. However, the underlying neural adaptations associated with these therapeutic approaches are not well understood. Our primary goal is to understand the motor control underpinnings of neurologic rehabilitation in order to apply this knowledge to future generations of therapeutic interventions.