Improving Self-Awareness of Motor Symptoms in Patients With Parkinson’s Disease by Using Mindfulness – A Study Protocol for a Randomized Controlled Trial

Buchwitz, Timo Marcel; Maier, Franziska; Greuel, Andrea; Eggers, Carsten

doi:10.3389/fpsyg.2020.00743

Cited by 6 publications

(9 citation statements)

References 87 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Diaries may not completely reflect all potential dysfunction during patient-defined non-troublesome dyskinesia as the dysfunction (troublesomeness) may only be present for a minority of the time period. Further, patients may not fully recognize their LID, including its functional impact (24)(25)(26). The reduction in ON time with non-troublesome dyskinesia may also be important to provide a buffer that allows clinicians to increase levodopa to further decrease OFF time and improve parkinsonian symptoms without increasing ON time with troublesome dyskinesia.…”

Section: Discussionmentioning

confidence: 99%

Amantadine ER (Gocovri®) Significantly Increases ON Time Without Any Dyskinesia: Pooled Analyses From Pivotal Trials in Parkinson's Disease

et al. 2021

View full text Add to dashboard Cite

Background: Clinical trials for antiparkinsonian drugs aimed at managing motor complications typically use patient diaries to divide levodopa-induced dyskinesias (LID) into “troublesome” and “non-troublesome” categories. Yet, given the choice, most patients would prefer to live without experiencing any dyskinesia. However, the concept of evaluating time spent ON without any dyskinesia as an outcome has never been tested. We conducted analyses of pooled Gocovri pivotal trial data in order to evaluate the extent to which Gocovri increased the time PD patients spent ON without dyskinesia (troublesome or non-troublesome), beyond its already identified improvement in reducing troublesome dyskinesia.Methods: Patients enrolled in phase 3 trials (EASE LID [NCT02136914] or EASE LID 3 [NCT02274766]) recorded time spent in the following PD diary states at baseline and Week 12 (endpoint): asleep, OFF, ON with troublesome dyskinesia, ON with non-troublesome dyskinesia, and ON without dyskinesia. Mixed model repeated measures analyses with estimated Cohen D effect sizes were performed on the modified intent to treat population to evaluate changes in time spent in these states.Results: Patients randomized to receive Gocovri showed an increase in ON time without dyskinesia and corresponding decreases in ON time with dyskinesia and OFF time vs. placebo. Treatment effects were statistically significant for Gocovri vs. placebo starting at Week 2 and were sustained until Week 12. On MMRM analysis at Week 12, patients in the Gocovri group showed an adjusted mean ± SE increase over placebo of 2.9 ± 0.6 h in ON time without dyskinesia (Cohen D effect size 0.79) and an adjusted mean ± SE decrease of −1.9 ± 0.6 h in ON time with dyskinesia (troublesome + non-troublesome) (Cohen D effect size 0.49), that included a −1.5 ± 0.4 h placebo-adjusted reduction in ON time with troublesome dyskinesia and a −0.6 ± 0.4 h reduction in ON time with non-troublesome dyskinesia. OFF time was reduced by −1.0 ± 0.3 h compared to placebo.Conclusions: Gocovri treatment more than doubled the daily time patients spent ON without dyskinesia. These results suggest that the Gocovri treatment effect was driven by a reduction in overall motor complications including ON time with both troublesome and non-troublesome dyskinesia as well as time spent OFF.

show abstract

Section: Discussionmentioning

confidence: 99%

Amantadine ER (Gocovri®) Significantly Increases ON Time Without Any Dyskinesia: Pooled Analyses From Pivotal Trials in Parkinson's Disease

et al. 2021

View full text Add to dashboard Cite

show abstract

“…The study has been approved by the local ethics committee of the University Hospital Marburg (study number: 119/18) and registered at the German Clinical Trials Register (DRKS00015807). A detailed description of the methodology has been previously published ( Buchwitz et al, 2020 ).…”

Section: Methodsmentioning

confidence: 99%

“… Course of the study. This figure has been adapted from a previous publication by Buchwitz et al (2020) . …”

Section: Methodsmentioning

confidence: 99%

“… ECFT-MI, Extended Complex Figure Test – Motor Independent Version; RWT, Regensburg verbal fluency test; TAP, test battery for attention; VLMT, Verbal learning and memory test; WAIS-IV, Wechsler Adult Intelligence Scale – Fourth Edition; and WMS-R, Wechsler Memory Scale-Revised. This table has been adapted from a previous publication by Buchwitz et al (2020) . * Tests used to check for mild cognitive impairment.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Pilot Study of Mindfulness Training on the Self-Awareness of Motor Symptoms in Parkinson’s Disease – A Randomized Controlled Trial

et al. 2021

Self Cite

View full text Add to dashboard Cite

Objective: This study aims to evaluate feasibility and effects of a newly developed mindfulness intervention tailored to specific needs of patients with Parkinson’s disease (PD).Background: The phenomenon of impaired self-awareness of motor symptoms (ISAm) in PD might be reduced by increasing patients’ mindfulness. A PD-specific mindfulness intervention has been developed and evaluated as a potential treatment option: IPSUM (“Insight into Parkinson’s Disease Symptoms by using Mindfulness”).Methods: IPSUM’s effectiveness is evaluated by comparing an intervention with a waitlist-control group. Applying a pre-post design, patients were assessed before, directly after and 8weeks after treatment. The primary outcome was the change in a quantitative ISAm score from baseline to post-assessment. Secondary outcome measures were PD-related affective changes and neuropsychological test performance. Feasibility was evaluated via feedback forms.Results: In total, 30 non-depressed and non-demented PD patients were included (intervention: n=14, waitlist-control: n=16). ISAm score did not change significantly, but the training group showed greater performance in sustained attention and language tasks over time. Additional changes included greater mindfulness as well as less sleeping problems and anxiety. Cognitive disturbances, apathy, and sleeping problems worsened only in the waitlist-control group. Patients’ feedback regarding the training concept and material was excellent.Conclusion: Insight into Parkinson’s Disease Symptoms by using Mindfulness has not been capable of reducing ISAm in PD patients but appears to be a feasible and effective concept to, among others, support mental health in the mid-term. It has to be noted though that the study was stopped beforehand because of the SARS CoV-2 pandemic. The lack of findings might therefore be caused by a lack of statistical power. The need for further research to better understand the mechanisms of ISAm and its connection to mindfulness in PD is highlighted.

show abstract

“…In relation to Parkinson’s disease, research suggests that self-awareness, a key cognitive process in SCEs, is altered [ 64 – 68 ]. Specifically, reduced self-awareness of memory (dys)function was positively correlated with disease severity, degree of memory decline and cognitive control deficits [ 69 ].…”

Section: Introductionmentioning

confidence: 99%

Autonomic factors do not underlie the elevated self-disgust levels in Parkinson’s disease

Aristotelidou

Tsatali²,

Overton

et al. 2021

PLoS ONE

View full text Add to dashboard Cite

Introduction Parkinson’s disease (PD) is manifested along with non-motor symptoms such as impairments in basic emotion regulation, recognition and expression. Yet, self-conscious emotion (SCEs) such as self-disgust, guilt and shame are under-investigated. Our previous research indicated that Parkinson patients have elevated levels of self-reported and induced self-disgust. However, the cause of that elevation–whether lower level biophysiological factors, or higher level cognitive factors, is unknown. Methods To explore the former, we analysed Skin Conductance Response (SCR, measuring sympathetic activity) amplitude and high frequency Heart Rate Variability (HRV, measuring parasympathetic activity) across two emotion induction paradigms, one involving narrations of personal experiences of self-disgust, shame and guilt, and one targeting self-disgust selectively via images of the self. Both paradigms had a neutral condition. Results Photo paradigm elicited significant changes in physiological responses in patients relative to controls—higher percentages of HRV in the high frequency range but lower SCR amplitudes, with patients to present lower responses compared to controls. In the narration paradigm, only guilt condition elicited significant SCR differences between groups. Conclusions Consequently, lower level biophysiological factors are unlikely to cause elevated self-disgust levels in Parkinson’s disease, which by implication suggests that higher level cognitive factors may be responsible.

show abstract

Improving Self-Awareness of Motor Symptoms in Patients With Parkinson’s Disease by Using Mindfulness – A Study Protocol for a Randomized Controlled Trial

Cited by 6 publications

References 87 publications

Amantadine ER (Gocovri®) Significantly Increases ON Time Without Any Dyskinesia: Pooled Analyses From Pivotal Trials in Parkinson's Disease

Amantadine ER (Gocovri®) Significantly Increases ON Time Without Any Dyskinesia: Pooled Analyses From Pivotal Trials in Parkinson's Disease

Pilot Study of Mindfulness Training on the Self-Awareness of Motor Symptoms in Parkinson’s Disease – A Randomized Controlled Trial

Autonomic factors do not underlie the elevated self-disgust levels in Parkinson’s disease

Contact Info

Product

Resources

About