Parkinson's Disease Clinical Trial
— Synch FitOfficial title:
Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease: a Feasibility Study
NCT number | NCT04467632 |
Other study ID # | 19_RIPH2-12 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2019 |
Est. completion date | April 2022 |
Verified date | October 2019 |
Source | University Hospital Center of Martinique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the
mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD)
patients, before taking the first morning dose of dopaminergic drugs.
The SB could represent a pathway for the development of new therapeutic strategies for motor
symptoms in PD.
Being a seemingly unpredictable phenomenon and a great variability daily, inter- and
intra-subject, the SB study requires multiple and repeated assessments of mobility for
several days. An experimental home setting would be optimal for this purpose in terms of
cost-effectiveness and patient acceptability.
In addition, since the extent and nature of SB have not been well characterized so far, and
the magnitude of its variability is unknown, a reliable assessment method, independent of
observers and situation, the SB is a requirement of further research in this area.
A recently developed technique combining machine learning algorithms with wireless portable
sensors (accelerometers and gyroscopes) and software applications could be particularly
promising for characterizing the complexity and multiplicity of SBs in. With this technique,
repeated and multiple assessments of mobility can be performed in the homes of patients
without the constant presence of a researcher.
This approach offers several advantages in terms of cost-effectiveness, feasibility and
acceptability of study protocols by patients. It also improves the ecological validity of
subjective and objective estimates of mobility in these patients.
The investigators chose to conduct this preliminary study on patients with PD rather than on
healthy subjects, because SB is a phenomenon that has been described so far only in this
population. Investigators also consider that the feasibility of the study will depend mainly
on the patients' ability to move and the context of their own illness.
SB is a phenomenon induced by sleep. The propensity and timing of sleep depend on the
coordinated interaction of the duration of the previous awakening (homeostatic process) and a
circadian signal (circadian process). In order to better understand SB, it is necessary to
study the reciprocal influences of the circadian and homeostatic process.
Investigators have devised a new paradigm to "shift" the circadian process phase around the
homeostatic process, maintained under constant conditions, in order to observe the effect of
the synchronism or desynchronization of these two processes on the awakening mobility of
patients with an MP. This experimental approach was approved by Professor Aleksandar
Videnovic (Harvard University School of Medicine, USA), opinion leader on circadian
rhythmicity in the MP and scientific collaborator of this study.
As a first step, the investigators plan to implement a technology-assisted home-based
methodology, to validate it in PD patients and to verify the logistic feasibility of this
method-assisted approach in a small group of patients, in order to to be able to apply this
paradigm in larger scientific projects.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2022 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients > 18 years old; - Patients affected with idiopathic PD, of both sexes; - Hoehn and Yahr stage of 2 to 4 in the "on" state; - Stable antiparkinsonian and/or psychotropic medications for at least 4 weeks prior to study screening; - Reliable partner/caregiver to assist the patient during the study procedures; - Affiliated person or beneficiary of a social security scheme; - Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: - Patients < 18 years old; - Atypical parkinsonian syndromes; - Dementia; - Treatment with extended-release dopaminergic drugs (excluding extended release levodopa given no later than 6 hours before the habitual bedtime); - Use of hypno-sedative drugs or stimulants; - Use of antidepressants unless on a stable dose for at least 3 months; - Travel through 2 time zones within 90 days prior to study screening; - Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness; - Any other medical condition potentially interfering with the assessment of mobility (e.g. limb amputation, post-stroke paralysis, severe osteo-articular condition); - Any condition limiting the capability of the subject to understand the task to be performed at home by the patient himself (e.g. aphasia, oligophrenia); - Severely altered physical and/or psychological health which, according to, the investigator, could affect the participant's compliance of the study; - Inadequate housing conditions to perform home assessments; - Patients refusing to participate in the study; - Patients under legal guardianship or curatorship, pregnant and breastfeeding women, women of child-bearing age, persons in emergency situations; - Persons participating in another research including a period of exclusion still in course and at any case < 1 month. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Martinique | Fort-de-France |
Lead Sponsor | Collaborator |
---|---|
University Hospital Center of Martinique |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of the objective metrics of mobility | The validity of the mobility assessment by Inertial Measurement Unit (IMU) wearable sensors will be verified. It will be defined as the accuracy of the machine learning algorithm to predict patients' motor status compared to the motor status assessed at clinical examination by means of the MDSUPDRS- III scale and the Fit test. Prediction by machine learning will be compared with the MDS-UPDRS-III total score and with the 3.14 item (global clinical impression of mobility) of the same scale. The patients will be asked to perform all the motor tasks of the MDS-UPDRS-III scale and the finger tapping test (Fit test) with both hands wearing the IMU system. |
12 months | |
Primary | Objective and subjective mobility | Prediction of mobility by machine learning based on data from IMU wearable sensors; finger tapping test; VAS motor | 12 months | |
Primary | Sleep and sleepiness | Measured by sleep diary, SSS | 12 months | |
Primary | Cognition (electronic Stroop test) | 12 months | ||
Primary | Emotional state | Measured by Visual Analog Scale(VAS) mood/anxiety | 12 months | |
Primary | Fatigue | Measured by VAS fatigue | 12 months | |
Primary | Circadian phase | Continuously for skin body temperature and repeated samples (every 30' for a total of 9 samples, in the evening around the bed time, for salivary DLMO | 12 months | |
Primary | Sleep homeostasis (SWA) | Calculated based on the EEG recording acquired by means of nocturnal portable polysomnography. | 12 months | |
Secondary | Chronotype | Measured by Horne & Ostberg Morningness/Eveningness Questionnaire (MEQ) | 12 months | |
Secondary | Sleep habits, sleep and wake-related symptoms, sleep quality | Measured by Pittsburgh Sleep Quality Index (PSQI) | 12 months | |
Secondary | PD-specific sleep and wake-associated symptoms | Measured by Parkinson's Disease Sleep Scale (PDSS-2) | 12 months | |
Secondary | Daytime symptoms of bad or insufficient sleep | Measured by Epworth Sleepiness Scale (ESS) [96] and Fatigue Severity Scale (FSS) | 12 months | |
Secondary | Modification of mobility on morning awakening | Measured by Sleep benefit questionnaire | 12 months | |
Secondary | Motor and non-motor symptoms of PD in daily living | Measurded by MDS-UPDRS scale (parts I, II and IV) | 12 months | |
Secondary | Neuropsychological battery useful in idiopathic PD | Measured by Mattis dementia rating scale (MDRS) | 12 months | |
Secondary | Mood | Measured by Beck Depression Inventory (BDI) | 12 months |
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