Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous...
Parkinson's Disease (PD)Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741. ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Optimal Verbal Instruction to Improve Walking for PD
Parkinson DiseaseGait Disorders1 moreBackground: One of the most disturbing motor symptoms in Parkinson's disease (PD) is gait disturbance. Clinicians often use various verbal instructions to correct abnormal gait patterns, and the most commonly used instruction is 'lift the foot up and make big steps.' Despite immediate performance improvement, people with PD are reluctant to walk outdoors with this exaggerated walking strategy because it makes them feel embarrassed, unbalanced, and fatigue easily. Since people with PD walk with flat foot, the investigators propose that an instruction emphasizing heel-strike at foot contact may be effective. When delivering verbal instructions, clinicians should also consider the attentional focus of the instruction. Evidence has shown that instructions with external focus of attention (EF) is more beneficial than internal focus of attention (IF) for motor performance and learning. However, most of the gait-related instructions for PD are IF. The investigators thus aim to design a novel EF instruction and determine whether people with PD can benefit more from EF than IF instruction. Objectives: (1) To investigate the effects of verbal instruction emphasizing heel-strike during gait training in people with PD. (2) To further determine whether an instruction with EF will induce greater training benefits than IF. Methods: Two experiments will be conducted in this study. In experiment 1, 60 individuals with PD will be randomized into the heel-strike (HS), big-step (BIG), and control (CON) groups. All participants will receive 12 sessions of gait training with the specific verbal instruction allocated for each group. The participants will be assessed before, immediately after, and 4 weeks after the interventions. The primary outcome will be gait performance, and the secondary outcomes will include measurements of cognitive and behavioral functions. Additionally, transcranial magnetic stimulation will be used to examine the changes of corticomotor excitability associated with the interventions. In the 2nd experiment, 46 individuals with PD will be randomized into the internal focus heel-strike (IF-HS) or external focus shoe-strike (EF-SS) group. Except for the verbal instruction provided to the participants, other intervention and testing procedures will be the same as experiment 1. Group × time repeated measures analysis of variance (ANOVA) will be used to compare the intervention effects among the groups, and a significance level will be set at α=0.05.
OpicApone Sleep dISorder
Parkinson DiseaseThe aim of this study is to To investigate in an exploratory manner the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated sleep disorders
eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.
Parkinson DiseaseThis is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Parkinson DiseaseThe purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.
tDCS of the Primary Motor Cortex to Improve Implicit Motor Sequence Learning in Parkinson's Disease...
Parkinson DiseaseParkinson1 moreImplicit motor sequence learning (IMSL) is a form of cognitive function that is known to be directly associated with impaired motor function in Parkinson's disease (PD). Research in healthy young participants shows the potential for transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, over the primary motor cortex (M1) to enhance IMSL. tDCS has direct effects on the underlying cortex, but also induces distant (basal ganglia) network effects - hence its potential value in PD, a prime model of basal ganglia dysfunction. To date, however, only null-effects have been reported in persons with PD. In the present study, the investigators will investigate the potential of tDCS delivered over M1 to enhance IMSL, as measured by the Serial Reaction Time task, in persons with PD. The investigators will determine immediate effects that may occur concurrently with the application of tDCS but also short-term (five minutes post-tDCS) and long-term (one week post-tDCS) consolidation effects, as previous studies suggest that tDCS exerts its beneficial effects on IMSL in a consolidation phase rather than in an acquisition phase. Establishing possible consolidation effects is of a particular interest, as long-term effects are vital for the successful functional rehabilitation of persons with PD.
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599...
Early-stage Parkinson's DiseaseThe purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.
NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or...
Mild Cognitive ImpairmentMild Dementia2 moreA Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia
Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients...
Parkinson DiseaseThe purpose of the STIMO-PARKINSON study is to evaluate the safety and preliminary efficacy of Targeted Epidural Spinal Stimulation (TESS) system to induce modulation in leg muscle recruitment in patients with advanced Parkinson's disease, and its capacity to improve key gait and balance deficits when employed in the context of a rehabilitation process of 3 to 5 months.
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
Parkinson DiseaseParkinson's patients usually have a significant decrease in respiratory muscle strength and respiratory function, which may increase in proportion to the severity of the disease. In addition, peripheral muscles may become dysfunctional by the rigidity caused by the disease. This reduces exercise capacity and may lead to a decrease in oxygen consumption. Respiratory muscle training has increased respiratory muscle strength in people with Parkinson's Disease (PD). However, its effectiveness on other functional outcomes has not been determined and studied.