Active clinical trials for "Parkinson Disease"

Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still worsen over time. Postural problems, frequent falls, freezing of gait impairment and other locomotion difficulties still remain as important causes of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life (QoL). This study aims to explore the effects of spinal cord stimulation in locomotion, falls and freezing of gait in advanced PD patients. Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a prospective study for six months. Changes in locomotion capacity and freezing of gait rating will be the primary out come. Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always comparing the status before, one, three and six months after stimulation was initiated. A double blind trial will be performed within three months of follow up (high X low frequency stimulation).

This study will evaluate whether whole-body vibration applied over a 12-week period is effective in treating motor symptoms of Parkinson's disease.

Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's disease patients, this is to confirm and further investigate the safety and efficacy using a similar dose. The possible beneficial effects on cognition in mildly cognitively impaired Parkinson's disease patients will also be tested, since this problem in Parkinson's disease may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter associated with multiple brain functions). During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a computer-based program.

Approximately 60% of the patients with Parkinson's Disease (PD) that receive Levodopa therapy eventually develop response fluctuations in motor symptoms, such as rigidity, freezing and akinesia. Patients experience an 'off'-period just before the next dose of dopaminergic medication is needed, called the 'wearing-off'-phenomena. Wearing-off is also accompanied by non-motor symptoms such as depression, anxiety, pain and thinking disability. Together, these motor and non-motor symptoms have a major impact on the quality of life of patients and their partner or caregiver. Patients with wearing-off often experience severe anxiety and panic symptoms that are incongruent with the severity of the motor symptoms during an 'off' period. These symptoms include stress, dizziness, pounding/racing of the heart, dyspnoea and hyperventilation. This type of anxiety is called wearing-off related anxiety (WRA) and might be a consequence of the hypersensitivity towards somatic manifestations and effects of a wearing-off period. This bodily misperception can have major consequences for the patient's feelings and behaviour. The experienced anxiety is often not consciously linked to the wearing-off and is therefore not well recognized by neurologists. Treatment as usual in response fluctuations is physiotherapy, consisting of physical exercises for mobility problems, freezing, dyskinesias, etc. This kind of training hardly touches upon the mental aspects and the role of anxiety as integral element of the response fluctuations. Cognitive behaviour therapy (CBT, including exposure in vivo) is sometimes used to treat WRA, but seems to have unsatisfactory results since the changed body awareness is not sufficiently addressed. Also, the methods used in cognitive therapies focus on the elimination of WRA which is often not realistic since wearing-off symptoms will remain or even increase during disease progression. As of yet, there are no known alternative intervention options. This study focuses on a new intervention by integrating elements from physiotherapy, mindfulness, CBT (mainly exposure), Acceptance and Commitment Therapy (ACT) and psycho-education. Objective: The current proposal aims at investigating the effect of a multidisciplinary non-verbal intervention on the awareness and modulation of WRA to improve self-efficacy, mobility, mood, and quality of life as compared to usual care. Study design: Randomized controlled clinical trial. Study population: Thirty-six PD patients who experience WRA. Intervention: Patients with PD are randomly allocated into one of two groups (n= 18 each). One group receives the experimental 'body-awareness therapy', while the second group receives regular group-physiotherapy (treatment as usual). Both interventions will take 6 weeks in which 2 sessions per week with a duration of 1,5 hour will be performed. Main study parameters/endpoints: The General Self-Efficacy Scale is the primary outcome measure and will be assessed prior to, directly after and 18 weeks after the intervention.

In Parkinson's disease, gait disturbances represent one of the most disabling motor symptoms, frequently associated with an increased risk of falls, loss of independence and a negative impact on quality of life. In recent years, the interest in automated robotic devices for gait training for Parkinson's Disease patients has grown. With their consistent, symmetrical lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may increase cortical activation and improve motor function while minimizing the intervention of a therapist. So the main aim of this study will be to analyze, through a clinical and an instrumental evaluation, the effectiveness of a Lokomat gait training in subjects affected by Parkinson's disease in comparison to a ground conventional gait training.

Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function. Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase. Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.

Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome non-motor symptom is pain. Currently these symptoms are treated with medication with limited success. Our study aims to determine whether relaxation guided imagery can alleviate pain in Parkinson's disease patients.

This study will evaluate the safety of an investigational cell transplantation therapy, ISC-hpNSC, in patients with Parkinson's disease. All patients will receive the therapy, which consists of human neural stem cells. Three dose levels will be examined in the study.

The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg) in Parkinson's disease with dementia compared to standard dose donepezil.

Objective/Rationale: The investigators objective is to demonstrate that an intervention program based on motor learning principles can be applied to train subjects with Parkinson's disease (PD) who suffer from freezing to walk in a way that minimizes the occurrence of freezing. Since sufficient motor learning capabilities are preserved in PD, the investigators hypothesize that an intervention program that targets the time periods just prior to an approaching freezing episode can modify the walking strategies so that the episode will now be averted. Project Description: The freezing burden will be quantified in subjects with PD before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode. Relevance to Diagnosis/Treatment of Parkinson's Disease: If even partially successful, the investigators will show, for the first time that freezing of gait is amenable to motor learning and that appropriate training with external cueing can alleviate these motor blockades. While future studies will be needed to further assess long-term efficacy and other important questions about clinical efficacy and the mechanisms involved, this study should go a long way towards improving the investigators understanding of freezing of gait and its amenability to appropriate therapy. Anticipated Outcome: The investigators anticipate that after intensive training, the central nervous system (CNS) of subjects with PD will be able to anticipate impending freezing episodes based on awareness of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious response to a deteriorating gait pattern. As a result, an automated motor response that paces and coordinates gait will be internally triggered by the CNS and the approaching freezing episode will be averted. The overall freezing burden will therefore decrease in trained subjects.