Clinical trial NCT01554306: Measuring the Effects of Continuous Dopaminergic Stimulation on Nocturnal Movements in Parkinson's Disease
Official title: Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nocturnal Hypokinesia
Parkinsons's Disease
Rotigotine
Lead sponsor: Sleep Medicine Centre Kempenhaeghe
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease with nocturnal hypokinesia based on the clinical interview who are going to start with rotigotine

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Position changes over the night.
timeFrame: max 1 year
Secondary outcomes:
measure: • Degree of mobility, measured as the speed of the movements
timeFrame: Max 1 year
measure: • Total amount of movements
timeFrame: Max 1 year
measure: • Score on the motor symptom scale according to the MDS-UPDRS part III
timeFrame: Max 1 year
Other outcomes:
Locations:
city: Heeze
country: Netherlands
facility: Sleep Medicine Centre Kempenhaeghe
Study officials:
affiliation: Sleep Medicine Centre Kempenhaeghe
name: Dirk AA Pevernagie, MD PhD
role: STUDY_DIRECTOR
References: