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Parkinson's Disease clinical trials

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NCT ID: NCT06418152 Recruiting - Parkinson's Disease Clinical Trials

Dual-task Augmented Reality for PD DBS

DART for DBS
Start date: April 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this project is to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD with a previously implanted deep brain stimulator (DBS).

NCT ID: NCT06406374 Recruiting - Parkinson's Disease Clinical Trials

Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire: an Observational, Multicentric, Cross-sectional, 6-months Duration Study on 200 Consecutive Parkinson's Disease Patients.

NoMoFA
Start date: April 26, 2023
Phase:
Study type: Observational

Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it is now recognized as a multisystemic disease involving not only the central nervous system and presenting with a constellation of motor and non-motor features. While the dopaminergic therapy used to control motor symptoms can lead to the development of motor fluctuations, characterized by wearing-off, ON-OFF phenomenon, delayed-ON, dose failure, and dyskinesias, it has been demonstrated that also many non-motor symptoms can have daily fluctuations, according to the response to dopaminergic therapy. Therefore, non-motor symptoms may fluctuate in parallel with motor symptoms and their relationship to plasma dopamine concentration, although the exact mechanism of non-motor fluctuations (NMF) remains speculative. Non-motor features tend to worsen during disease progression and prove to severely impact the quality of life of patients, sometimes more than motor symptoms. The Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire is a patient-derived and self-administered questionnaire, recently developed and validated by the International Parkinson and Movement Disorder Society (MDS), that identifies and quantifies the severity of static and fluctuating non-motor symptoms in people with PD. The NoMoFA scale is constituted of a total of 27 items investigating several non-motor features, such as fatigue (the most reported), sleepiness, and confusion. Considering the self-administered nature of the scale, patients must understand the questions, and it should be available in the patient's native language. However, the NoMoFa has not yet been translated into the Italian language. Considering that NoMoFA is a relevant scale in the assessment of patients with PD, we believe it is important to perform a translation and cross-cultural adaptation of the NoMoFA questionnaire in Italian, following the scales translation protocol from the international movement disorders society (MDS), and to analyze the reliability and construct validity of the translated scale in Italian patients with PD who experience non-motor fluctuations. The aim of the study is to translate and validate the adapted Italian version of NoMoFA questionnaire.

NCT ID: NCT06324422 Recruiting - Parkinson's Disease Clinical Trials

Exercise as Treatment of Fatigue in Parkinson´s Disease

Start date: April 24, 2024
Phase: N/A
Study type: Interventional

The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD). The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period). It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis).

NCT ID: NCT06304285 Recruiting - Parkinson's Disease Clinical Trials

A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD

NCT ID: NCT06239454 Recruiting - Parkinson's Disease Clinical Trials

Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

This study is designed as a prospective, randomized, double-blind, controlled study to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to post-operation dyskinesia control. The primary objective is to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to dyskinesia control.

NCT ID: NCT06175897 Recruiting - Parkinson's Disease Clinical Trials

Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

In recent years, deep brain stimulation (DBS) has become the primary treatment for patients with medically uncontrolled Parkinson's disease (PD). Nevertheless, previous studies have shown that it has been controversial whether DBS-subthal amic nucleus (STN) has facilitated or impaired cognitive function in patients with PD. The etiology of the effect of DBS on the single cognitive domain, executive function, has yet to be clarified. Previous clinical studies in which DBS was performed in patients with PD have been performed under the Stroop effect. TMT (Trail Making Test A and B) cognitive tests and simultaneous acquisition of brain function data by electroencephalograph-functional near-infrared spectroscopy (EEG-fNIRS) have yet to be reported. To investigate the effect of DBS-STN on executive function in PD patients and whether there are differences at baseline, 1-month postoperative (DBS-on), 6 months postoperative follow-up, and 12 months postoperative follow-up. Under the condition of electroencephalograph-functional near-infrared spectroscopy (EEG-fNIRS) bimodal technology fusion, The investigators allow PD patients to operate the test of executive function (Stroop/TMT), real-time monitoring of cranial neurophysiology-oxygenation signals, and explore the changes of the brain function network of PD patients, and hope to achieve the following objectives through objective and scientific-technological means: (1) quantify the cognitive function of PD patients through EEG-fNIRS technology and possible trends of changes; (2) explain whether executive functions differ at the level of brain functional network connectivity between surgical and conservative treatments and whether the differences have interaction effects with treatment duration and treatment modalities, as well as analyze their simple effects; (3) To minimize artificial confounders of short-term learning effects and testers common to previous neurocognitive psychobehavioral tests; (4) To explore the mechanism of DBS on the changes of cortical brain networks in PD patients, to avoid or reduce the interference of surgery on cognitive functions, and to provide a theoretical basis for treating personalized surgical plans.

NCT ID: NCT06154356 Recruiting - Parkinson's Disease Clinical Trials

Action Observation and Motor Imagery Therapy in Parkinson's Disease

Start date: December 14, 2023
Phase: N/A
Study type: Interventional

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in Parkinson's disease (PD). Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind. The aim of this clinical trial is to test whether the application of AO and MI treatment in PD in addition to conventional rehabilitation programs has an additional effect on Balance, Functional Status and Quality of Life.

NCT ID: NCT06098612 Recruiting - Parkinson's Disease Clinical Trials

PET Imaging Evaluation of [11C]SY08

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

The overall goal of the proposed research is to evaluate the use of [11C]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls. The purpose of this study is to evaluate the use of [11C]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The specific aims of the current study are: 1. To determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals. 2. To determine brain uptake, distribution, and kinetics of [11C]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. 3. To determine human dosimetry of [11C]SY08 in healthy individuals An intravenous bolus injection of [11C]SY08 will be administered per subject for brain PET imaging.

NCT ID: NCT06051877 Recruiting - Parkinson Disease Clinical Trials

Ocular Microtremor in Parkinson's Disease.

OMTinPD
Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive, motor (using the UPDRS-III) and OMT measures. With OMT as the primary outcome, assessment with the iTremor is incredibly quick, taking just three seconds to obtain a reading. PwPD will be assessed both 'off' and on their anti-parkinsonian medication. 'Off' is defined as a 12Hr overnight washout period where participants are tested in the morning prior to their first dose. PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance, gait, and turning using wearable sensors. 40 PwPD, 20 with suspected PD, and 40 age-matched healthy control participants will be recruited for assessment of OMT. Ten PwPD will complete a test-retest reliability assessment at the same approx. time, exactly one week after their initial visit.

NCT ID: NCT06009471 Recruiting - Parkinson's Disease Clinical Trials

A Multicenter Clinical Study of rTMS for Parkinson's Disease

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.