Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations

NCT07074119 | Not Yet Recruiting

• 2 other identifiers: APHP1806092019-A00322-55
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

Although numerous tools have been developed in recent years with the enhancement of new technologies precision and the reduction of their size, still few medical devices are used in clinical routine in Parkinson's Disease. Knowledge about Parkinson's Disease motor symptoms has been widely improved especially thanks to objective monitoring of movements. However, patients are mostly observed in defined environment during scripted activities, which is per se distinct from the real life conditions. Besides, experts may agree on the limitations of the diary that is supposed to reflect the patient's status at home, while outpatients' visits may also not correctly enable the neurologist to catch up the everyday life condition of the patient. In order to overcome some of these issues, we hypothesize that the implementation of body-worn sensors at home monitoring could provide promising solutions. Yet, important information is missing: there is no previous randomized trial studying the additional value of body-worn sensors to improve motor symptoms, quality of life and ability to perform everyday life activities for example. To our knowledge, our study proposal is the first one to adjust therapy of patients with Parkinson's Disease based on the reports of body-worn sensors monitoring. If the efficacy and reliability of at home monitoring with sensors is proven, new healthcare guidelines could arise with the objective of a better and continuous patient's follow-up, remotely from the outpatient's visit.

Conditions

Parkinson Disease (PD)

Keywords

Adjusment Therapy; Dyskinesis; Time ON; Time OFF; Bradykinesia; Parkinson Kinetic Graff; Body-worn Sensors; Parkinson Watch; self-reported diary

Outcome Measures

Primary Outcomes (1)

• Change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary.

  The daily time spent in OFF states will be reported by the patient on his/her diary per periods of thirty minutes each day for a duration of 3 days before baseline visit and before 6 months visit. For each day, the total daily time spent OFF will be calculated as the sum of every 30 minutes' periods stated as OFF time. This duration will be averaged over the 3 days period at baseline (W0 +/-7 days) and 6 months (W24 +/- 7 days) visits and the difference between the two visits will be calculated.

  Baseline (W0) and 6 months visit (W24)

Secondary Outcomes (11)

• Change in time spent in good ON state without troublesome dyskinesia (i.e. good time ON) between baseline and 6 months on self-reported diary (mean of previous 3 days)

  Baseline (W0) and 6 months visits (W24)

• Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months on self-reported diary (mean of previous 3 days)

  baseline (W0) and 6 months visits (W24)

• Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS part II-motor aspects of experiences of daily living) between baseline and 6 months

  baseline (W0) and 6 months visits (W24)

• Change of the score of Parkinson Disease Quality of life questionnaire (PDQ-39) related between baseline and 6 months

  baseline (W0) and 6 months visits (W24)

• Number of patients with at least one dopaminergic drug-related side effects between groups during the study period.

  baseline (W0), 1 month visit (W4), 3 months visit (W12) and 6 months (W24)

Other Outcomes (8)

• Change in time spent in OFF state between baseline and 6 months based on the BWS assessment

  baseline (W0) and 6 months visits (W24)

• Change in time spent in good ON state (i.e. time ON without troublesome dyskinesia) between baseline and 6 months based on the BWS assessment.

  baseline (W0) and 6 months visits (W24)

• Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months based on the BWS assessment

  baseline (W0) and 6 months visits (W24)

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be made available to the neurologist.

Device: wearable-based adjustment therapy

Control group

ACTIVE COMPARATOR

Patients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be blinded and NOT be made available to the neurologist.

Device: wearable-based adjustment therapy

Interventions

wearable-based adjustment therapy DEVICE

* Patients will wear the BWS for 7 days prior to each of the visit : baseline (V1) at week 0, V2 at week 4 (phone call at 1 month), V3 at week 12 (3 months visit) and V4 at week 24 (6 months). * Data extracted from each session of monitoring with the BWS will be made available to the neurologist (only in the experimental group) prior to V1 (W0), V2 (W4), V3 (W12) and V4 (W24) respectively * Treatment adjustment will be guided by the current consensus guidelines for treatment adjustment for motor fluctuations in PD using reports from BWS data. Reports will be screened by neurologists before the patient's visit so the groups blinding is correctly observed

Control group; Experimental group

Eligibility Criteria

• Age: 46 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's since \> 4 years
• Patient between years 46-83 (according to the BWS range of validity)
• Presence of motor fluctuations as defined by a score ≥ 2 (item 4.3) and a score ≥ 1 (item 4.4) of the MDS-UPDRS part IV
• At least 3 doses per day of L-Dopa
• Need of therapeutic adjustment because of motor fluctuations according to the neurologist opinion
• Hoehn and Yahr stage ≤ 3 in OFF state

You may not qualify if:

• No signature of informed consent
• Anticipated uncompliance or inability to use the self-reported diary or to wear the devices
• Cognitive impairment (MMSE \< 24)
• Patient treated with second line therapies ((Subcutaneous or digestive pump therapies or deep brain stimulation) or planed for the 6 next months.
• Pregnant or breastfeeding women
• Patients living in nursing home
• Patient already participating in another clinical investigation or interventional study.

Sponsors & Collaborators

• NS-PARK Network: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre d'investigations cliniques Pitié-Salpêtrière University Hospital

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Grabli, Professor

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

• Jean Chritophe Corvol, Professor

  Assistance Publique Hopitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

David Grabli, Professor

CONTACT

01 42 16 24 61; david.grabli@aphp.fr

Sofia Zemouri, Master

CONTACT

01 42 16 75 75; sofia.zemouri@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 20, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2026-01

Locations

FR (1)