Active clinical trials for "Parkinson Disease"

Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control. Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly. Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training. Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up. Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.

The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.

To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

The purpose of this study is to gain a better understanding of how exercise training affects motor/hand function and brain function in those diagnosed with Parkinson's disease. The investigators want to study if exercise will improve hand function and improve the level of brain activity.

This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure. Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

The objectives of this study were to evaluate the efficacy, safety, and tolerability of pramipexole, as single-agent therapy or in combination with levodopa, in patients with Parkinson disease living in Hong Kong and Taiwan.

Rationale: Visual hallucinations (VH) are the most common non-motor symptoms in Parkinson's disease (PD). As an independent predictor for cognitive decline and nursing home placement they form an important disability milestone in the course of PD. According to current clinical guidelines minor VH do not require treatment per se. But as minor VH precede the stage of major VH without insight and PD associated psychosis (PDP) they offer an opportunity for early intervention. Neuroleptic drugs delay the transition into PDP but are unsuitable for early treatment of VH due to their side effects. We hypothesize that cholinesterase inhibitors (ChEI) are a well-tolerated alternative for the early treatment of minor VH to delay the progression to PDP, and that brain network analysis is suitable to predict treatment response. Objective: Investigate whether early treatment with ChEI delays the progression of minor VH to major VH without insight or PDP. In addition, we will measure motor control, psychotic symptoms, cognitive impairment, mood disorders, daytime sleepiness, adverse events and compliance, disability, caregiver burden and care use. We assess the cost-effectiveness of early chronic treatment of VH with ChEI. Finally, we analyse changes of functional brain networks before and during treatment. Study design: A randomized, double blind, placebo-controlled, multi-center trial with an economic evaluation. Study population: 168 patients with PD and VH after fulfilling the in-and exclusion criteria. Intervention: Rivastigmine capsule 6 mg BID or placebo BID for 24 months. Main study parameters/endpoints: The primary outcome measure is the median time until PD patients with minor VH progress to major VH without insight. The clinical endpoint is defined as the start with antipsychotic treatment. Secondary outcome measures are changes in motor control, psychotic symptoms, cognitive impairment, mood disorders, daytime sleepiness, cholinergic deficiency, the number of adverse events, compliance, disability and caregiver burden. The median time until PD patients with minor VH progress to PD dementia is measured by means of changes in cognitive function. The secondary neurophysiological outcome measures are peak frequency, functional connectivity, topological network organisation and the direction of information flow. All relevant costs will be measured and valued. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation consists of a total of 5 clinical visits (every 6 months), 5 telephone interviews on adverse events during the escalation phase and 9 questionnaires on health related costs (every 3 months). In a subgroup 3 additional visits for EEG recording are needed. There is a risk for adverse reactions with rivastigmine treatment; the most common are nausea and vomiting.

The purpose of this study is to determine if Leukine (sargramostim) can be safely administered to Parkinson's disease patients for an extended period of time (56 days) and restore immune deficits seen in Parkinson's patients compared to controls. The development of magnetoencephalography (MEG) as a monitoring tool for PD will also be explored. At enrollment and repeating again at two 4-week intervals, whole blood from PD patients and controls will be obtained for analyses and the results will be used to calculate immune response profiles as a baseline for comparison after drug treatment. Physical examinations and motor assessments will also be performed on PD patients. After the 8-week baseline data collection, control participation will end and drug treatment of PD patients will begin. PD patients will be randomized, and half will receive drug and half will receive placebo. Leukine at a dosage of 6 µg/kg or saline as placebo will be administered by subcutaneous injection daily for 56 days (8 weeks). During drug treatment, PD patients will be monitored every two weeks by physical examinations, motor assessments, and blood analyses. As follow-up, four weeks after drug administration has stopped, subjects will again have physical examinations, motor assessments, and blood analyses. MEG will be performed on PD patients and controls at the start of drug treatment, and on PD patients at the end of the drug treatment period and 4 weeks after drug is stopped. In addtion, at the second cohort of 8 PD subjects, we will evaluate the potential Leukine-induced motor control and mobility improvements. Also, levels of the neurotransmitters glutamate, glutamine, serotonin, acetylcholine, GABA, norepinephrine and epinephrine in serum/plasma will be analyzed to correlate with changes in motor function and drug treatment.