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

Parkinsons's Disease Clinical Trial

Official title:

Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01554306
• Other study ID #: 38851.091.11
• Status: Terminated
• Phase: N/A
• First received: March 5, 2012
• Last updated: October 28, 2016
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Sleep Medicine Centre Kempenhaeghe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypokinesia
• Nocturnal Hypokinesia
• Parkinson Disease
• Parkinsons's Disease
• Rotigotine

Locations

Country	Name	City	State
Netherlands	Sleep Medicine Centre Kempenhaeghe	Heeze

Sponsors (1)

Lead Sponsor	Collaborator
Sleep Medicine Centre Kempenhaeghe

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Position changes over the night.		max 1 year	No
Secondary	• Degree of mobility, measured as the speed of the movements		Max 1 year	No
Secondary	• Total amount of movements		Max 1 year	No
Secondary	• Score on the motor symptom scale according to the MDS-UPDRS part III		Max 1 year	No