CovidResearchTrials by Shray Alag

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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drug2167 Placebo treatment Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D010300 Parkinsonian NIH 0.50

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There is one clinical trial.

Clinical Trials

1 Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease

This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD) patients treating twice daily time-varying caloric vestibular stimulation treatment using a solid-state device developed by Scion NeuroStim, LLC. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and will be compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD. The durability of effects will be evaluated at a post-treatment assessment conducted five weeks after treatment cessation.

NCT04493697 Parkinson Disease Device: Active treatment Device: Placebo treatment
MeSH:Parkinson Disease

Primary Outcomes

Description: Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

Measure: Neuroimaging

Time: Baseline

Description: Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

Measure: Neuroimaging

Time: Week 12

Description: Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

Measure: Neuroimaging

Time: Week 17

Description: Non-invasive ultrasound used to examine blood circulation within the brain - range measured by statistically significant change in mean cerebral blood flow velocity (cm/s)

Measure: Transcranial Doppler Sonography

Time: Baseline

Description: Non-invasive ultrasound used to examine blood circulation within the brain - range measured by statistically significant change in mean cerebral blood flow velocity (cm/s)

Measure: Transcranial Doppler Sonography

Time: Week 12

Secondary Outcomes

Description: Used to follow the longitudinal course of symptoms of Parkinson's disease - Each parkinsonian sign or symptom is rated on a 5‐point Likert‐type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD

Measure: MDS-Unified Parkinson's Disease Rating Scale

Time: Baseline, Week 12, Week 17

Description: To determine fall risk and measure the progress of balance, sit to stand and walking (ranging from ≤10 seconds as normal to 30 seconds as high fall risk).

Measure: Timed Up and Go Test

Time: Baseline, Week 12, Week 17

Description: Cognitive screening test - range from zero to 30, with a score of 26 and higher generally considered normal.

Measure: Montreal Cognitive Assessment

Time: Baseline, Week 12, Week 17

Description: Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions - the total NMSQuest score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses.

Measure: Non-Motor Symptom Scale

Time: Baseline, Week 12, Week 17

Description: A self-report measure of depression in older adults - Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

Measure: Geriatric Depression Scale

Time: Baseline, Week 12, Week 17

Description: Anxiety assessment - The PAS is a 12-item observer or patient-rated scale with three subscales, for persistent, episodic anxiety and avoidance behavior - There is a maximum total score of 48. Higher scores indicate great experiences of anxiety.

Measure: Parkinson's Anxiety Scale

Time: Baseline, Week 12, Week 17

Description: A self-administered questionnaire to assess the daytime sleepiness - The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

Measure: Epworth Sleepiness Scale

Time: Baseline, Week 12, Week 17

Description: A tool to help manage chronic illness - The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4‐point Likert scale. Thus, the total score ranges from 0 to 52. High scores represent less fatigue

Measure: Functional Assessment of Chronic Illness Therapy - Fatigue -

Time: Baseline, Week 12, Week 17

No related HPO nodes (Using clinical trials)