Evaluation of smartphone-based testing to generate exploratory outcome measures in a phase 1 Parkinson's disease clinical trial

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

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Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

Journal of Dance Medicine & Science ◽

10.12678/1089-313x.031522a ◽

2021 ◽

Author(s):

Jéssica A. Moratelli ◽

Kettlyn H. Alexandre ◽

Leonessa Boing ◽

Alessandra Swarowsky ◽

Clynton L. Corrêa ◽

...

Keyword(s):

Parkinson’S Disease ◽

Clinical Trial ◽

Parkinson's Disease ◽

Randomized Clinical Trial ◽

Rating Scale ◽

Freezing Of Gait ◽

Motor Symptoms ◽

Score Change ◽

Significant Difference ◽

Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

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The Add-On Effect of Lactobacillus plantarum PS128 in Patients With Parkinson's Disease: A Pilot Study

Frontiers in Nutrition ◽

10.3389/fnut.2021.650053 ◽

2021 ◽

Vol 8 ◽

Author(s):

Chin-Song Lu ◽

Hsiu-Chen Chang ◽

Yi-Hsin Weng ◽

Chiung-Chu Chen ◽

Yi-Shan Kuo ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Lactobacillus Plantarum ◽

Outcome Measures ◽

Rating Scale ◽

Controlled Trial ◽

Secondary Outcome ◽

Motor Deficits ◽

Motor Symptoms ◽

Non Motor Symptoms

Background:Lactobacillus plantarum PS128 (PS128) is a specific probiotic, known as a psychobiotic, which has been demonstrated to alleviate motor deficits and inhibit neurodegenerative processes in Parkinson's disease (PD)-model mice. We hypothesize that it may also be beneficial to patients with PD based on the possible mechanism via the microbiome-gut-brain axis.Methods: This is an open-label, single-arm, baseline-controlled trial. The eligible participants were scheduled to take 60 billion colony-forming units of PS128 once per night for 12 weeks. Clinical assessments were conducted using the Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn and Yahr scale, and change in patient “ON-OFF” diary recording as primary outcome measures. The non-motor symptoms questionnaire, Beck depression inventory-II, patient assessment of constipation symptom, 39-item Parkinson's Disease Questionnaire (PDQ-39), and Patient Global Impression of Change (PGI-C) were assessed as secondary outcome measures.Results: Twenty-five eligible patients (32% women) completed the study. The mean age was 61.84 ± 5.74 years (range, 52–72), mean disease duration was 10.12 ± 2.3 years (range, 5–14), and levodopa equivalent daily dosage was 1063.4 ± 209.5 mg/daily (range, 675–1,560). All patients remained on the same dosage of anti-parkinsonian and other drugs throughout the study. After 12 weeks of PS128 supplementation, the UPDRS motor scores improved significantly in both the OFF and ON states (p = 0.004 and p = 0.007, respectively). In addition, PS128 intervention significantly improved the duration of the ON period and OFF period as well as PDQ-39 values. However, no obvious effect of PS128 on non-motor symptoms of patients with PD was observed. Notably, the PGI-C scores improved in 17 patients (68%). PS128 intervention was also found to significantly reduce plasma myeloperoxidase and urine creatinine levels.Conclusion: The present study demonstrated that PS128 supplementation for 12 weeks with constant anti-parkinsonian medication improved the UPDRS motor score and quality of life of PD patients. We suggest that PS128 could serve as a therapeutic adjuvant for the treatment of PD. In the future, placebo-controlled studies are needed to further support the efficacy of PS128 supplementation.Clinical Trial Registration:https://clinicaltrials.gov/, identifier: NCT04389762.

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Neuropsychological Effects of Deep Brain Stimulation in Subjects with Early Stage Parkinson's Disease in a Randomized Clinical Trial

Journal of Parkinson s Disease ◽

10.3233/jpd-140448 ◽

2015 ◽

Vol 5 (1) ◽

pp. 151-163 ◽

Cited By ~ 8

Author(s):

Michael G. Tramontana ◽

Anna L. Molinari ◽

Peter E. Konrad ◽

Thomas L. Davis ◽

Scott A. Wylie ◽

...

Keyword(s):

Parkinson’S Disease ◽

Clinical Trial ◽

Parkinson's Disease ◽

Deep Brain Stimulation ◽

Randomized Clinical Trial ◽

Brain Stimulation ◽

Early Stage ◽

Neuropsychological Effects ◽

Deep Brain

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Comparable indicators of therapeutic misconception between epilepsy or Parkinson’s disease patients between those with clinical trial experience and trial non-participants

Seizure ◽

10.1016/j.seizure.2018.06.006 ◽

2018 ◽

Vol 60 ◽

pp. 61-67 ◽

Cited By ~ 3

Author(s):

Emmi Reijula ◽

Arja Halkoaho ◽

Anna-Maija Pietilä ◽

Tuomas Selander ◽

Kirsti Martikainen ◽

...

Keyword(s):

Parkinson’S Disease ◽

Clinical Trial ◽

Parkinson's Disease ◽

Therapeutic Misconception ◽

Trial Experience ◽

Clinical Trial Experience

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Home-based dance exercise for adults with moderate Parkinson’s disease: Protocol with a pilot study for a non-randomized clinical trial using video-dances in a DVD format (Preprint)

10.2196/preprints.36095 ◽

2022 ◽

Author(s):

Manoela de Paula Ferreira ◽

Adriano Zanardi da Silva ◽

Bruna Yamaguchi ◽

Sunita Mathur ◽

Taina Ribas Melo ◽

...

Keyword(s):

Quality Of Life ◽

Parkinson’S Disease ◽

Clinical Trial ◽

Parkinson's Disease ◽

Cognitive Function ◽

Pilot Study ◽

Functional Mobility ◽

Contemporary Dance ◽

Home Based

BACKGROUND Many people with Parkinson’s disease (PD) have never received rehabilitation care due to lack of accessibility and transportation and high therapy costs for in-person rehabilitation. Home-based dance exercise is an innovative, low-cost therapy that may reduce accessibility barriers to exercise. Especially since the COVID-19 pandemic, home-exercise programs are a highly relevant, alternative approach for people with PD OBJECTIVE This clinical trial protocol aims to explore the effects of a Home-Based contemporary dance exercise program for people with moderate Parkinson’s Disease (PD), focusing on balance, functional mobility, quality of life (QOL), cognitive function, and depression. METHODS This protocol is for a non-randomized clinical trial for adults with moderate PD divided into control group (CG) and Experimental Group (EG). Participants from the EG will perform video-dances of the contemporary dance, delivered in a DVD format. The video-dances will be executed 16 weeks, three times per week, 30 minutes each day at home, with exercise intensity controlled by the BORG scale. Participants from the CG will not receive any new exercise therapy. As primary outcomes, the signs and symptoms of the PD assessed by the Unified Parkinson’s Disease Rating Scale – UPDRS II and III, Hoehn and Yahr for the PD severity, and health-related quality of life (HRQL), measured by the Parkinson’s Disease Questionnaire – PDQ-39) will be tested. Secondary outcomes include cognitive function by the Montreal Cognitive Assessment – MoCA, balance by the Mini-BESTest, functional mobility by the Timed “Up and Go” test – TUG and depression by the Geriatric Depression Scale – GDS. All outcomes will be assessed in an in-person evaluation by a blinded assessor before and after the 16 weeks of the program. RESULTS This protocol has a pilot study that included 10 participants (5 in each group). It was observed positive results favoring the EG over cognitive function (p = 0.034). In addition, HRQL, balance, and depression were improved after the pilot program in the EG, however, without significant difference. CONCLUSIONS This clinical trial has the potential to be a safe alternative exercise approach under COVID restrictions and travel-free therapy with effects on PD symptoms. CLINICALTRIAL RBR-58T68W (Brazilian Clinical Trials Registry)

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