MedDataX Logo

Measuring the Effects of Continuous Dopaminergic Stimulation on Nocturnal Movements in Parkinson's Disease

NCT ID: NCT01554306

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can also be present during the night. Half of the patients with PD have difficulty turning around in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in this population. The diagnosis nocturnal hypokinesia is based on the clinical interview. There is a need for a diagnostic devices that measures nocturnal movements, preferably in the home setting. This device can be used in the diagnostic trajectory as well in the evaluation of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to register nocturnal movements. The tri-axial accelerometer has been developed to measure position changes in the night. A validation study with actigraphy and polysomnography concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and physical activity and changes of body position during sleep.

Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of dopaminergics is adequate, but most of the time slow release dopaminergics are needed. However response fluctuations can negatively influence the treatment. In these cases continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response fluctuations during the day and studies show that sleep quality measured with questionnaires improves. If the improvement of sleep quality is caused by improved bed mobility has not been studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia in PD.

Objective of the study:

Primary:

• To study the effect of rotigotine on nocturnal hypokinesia

Secondary:

* To study the possibility of measuring nocturnal hypokinesia and its severity in a home setting
* To correlate improvements in sleep quality by rotigotine with changes in nocturnal hypokinesia

Study design:

We will study patients who will recieve rotigotine as a part of their usual care. During three nights, nocturnal movements are being registered with movement sensors, before treatment has started as well as after a stable medication dose of one month. We will also assess sleep quality with questionnaires.

Study population:

The study population are patients with Parkinson's disease with sleep problems caused by nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We will ask the treating neurologist to inform us when a patient will start treatment with rotigotine. One of the researchers will contact the patient to give further information about the study. The study is a first hypothesis generating study and we will start with the inclusion of 10 patients.

Intervention (if applicable):

Primary study parameters/outcome of the study:

Position changes over the night.

Secundary study parameters/outcome of the study (if applicable):

Objective

* Degree of mobility, measured as the speed of the movements
* Total amount of movements
* Score on the motor symptom scale according to the MDS-UPDRS part III

Subjective

* Nocturnal sleep quality Excessive daytime sleepiness
* Presence of nocturnal akinesia

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nocturnal Hypokinesia Parkinsons's Disease Rotigotine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

parkinson's disease, nocturnal hypokinesia, rotigotine

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with idiopathic PD (defined by UK Brain Bank criteria)
* Patients who will start treatment with rotigotine
* Hoehn \& Yahr stage II - IV
* Subjective sleep problems most likely caused by nocturnal hypokinesia, based on clinical interview

Exclusion Criteria

* Other significant causes for nocturnal motor symptoms which are not dopamine-responsive
* Previous surgery for PD
* Mini- mental state examination score \< 25
* Concurrent hallucination or psychosis
* History of skin hypersensitivity to adhesives or other transdermals
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sleep Medicine Centre Kempenhaeghe

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

D.A.A. Pevernagie, MD PhD

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dirk AA Pevernagie, MD PhD

Role: STUDY_DIRECTOR

Sleep Medicine Centre Kempenhaeghe

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sleep Medicine Centre Kempenhaeghe

Heeze, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

38851.091.11

Identifier Type: -

Identifier Source: org_study_id