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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sleep Medicine Centre Kempenhaeghe.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
D.A.A. Pevernagie, MD PhD, Sleep Medicine Centre Kempenhaeghe
ClinicalTrials.gov Identifier:
NCT01554306
First received: March 5, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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

Condition
Nocturnal Hypokinesia
Parkinsons's Disease
Rotigotine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Sleep Medicine Centre Kempenhaeghe:

Primary Outcome Measures:
  • Position changes over the night. [ Time Frame: max 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Degree of mobility, measured as the speed of the movements [ Time Frame: Max 1 year ] [ Designated as safety issue: No ]
  • • Total amount of movements [ Time Frame: Max 1 year ] [ Designated as safety issue: No ]
  • • Score on the motor symptom scale according to the MDS-UPDRS part III [ Time Frame: Max 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
parkinson's disease, nocturnal hypokinesia, rotigotine

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554306

Contacts
Contact: Sebastiaan Overeem, MD PhD +31 40 227 90 22 overeems@kempenhaeghe.nl
Contact: Maartje Louter, MD +31 40 227 90 22 louterm@kempenhaeghe.nl

Locations
Netherlands
Sleep Medicine Centre Kempenhaeghe Recruiting
Heeze, Netherlands, 5591 VE
Contact: Maartje Louter, MD    +31 40 277 9022    louterm@kempenhaeghe.nl   
Sponsors and Collaborators
Sleep Medicine Centre Kempenhaeghe
Investigators
Study Director: Dirk AA Pevernagie, MD PhD Sleep Medicine Centre Kempenhaeghe
  More Information

No publications provided

Responsible Party: D.A.A. Pevernagie, MD PhD, MD PhD, Sleep Medicine Centre Kempenhaeghe
ClinicalTrials.gov Identifier: NCT01554306     History of Changes
Other Study ID Numbers: 38851.091.11
Study First Received: March 5, 2012
Last Updated: March 12, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Parkinson Disease
Hypokinesia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Dopamine Agents
Dopamine Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014