• PDtrials - Parkinson's Disease Clinical Trials
• /Browse By Type
• /Observation (No intervention)

Official Study Title: The Characteristics of Sequence Effect in de Novo  De NovoLiterally Latin meaning “from the beginning”, generally refers to Parkinson’s patients who have not yet begun medication for their disease. and Advanced Parkinson's Disease
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID: NCT00431366
Study ID: 070088; 07-N-0088

Summary

This study will explore sequence effect, a fatigue or tiredness commonly seen in persons with Parkinson's disease after they have been doing the same thing for a while. The study will use a new device called a modified peg board test to measure whether antiparkinsonian medications (levodopa/  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. carbidopa  CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. or dopamine)  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. and repetitive transcranial magnetic stimulation  Transcranial Magnetic Stimulation (TMS)Brief electrical currents are passed through an insulated wire coil placed on the subject's scalp and the coil, creating magnetic pulses that pass into the brain. (rTMS) of the brain can improve the symptoms of sequence effect. The modified pegboard test is a computer-based machine with eight pegs. Participants transfer each peg from a line of holes on the right side to a line of holes on the left side using their right hand and moving as quickly as possible. rTMS involves repeated magnetic pulses delivered in trains or short bursts of impulses. Persons with early-stage PD who have never taken antiparkinsonian medications (de novo) and persons with advanced disease may be eligible for this study.

Study Phase

Not Specified
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Contact trial organizers

Eligibility

• Minimum Age: 18
• Gender(s) Accepted: Either

Inclusion Criteria

• Right-handed.
• Able to provide consent for the protocol.  ProtocolA plan that is the basis for the conduct of a clinical trial ensuring the health of participants, and the solutions to specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications and dosages, and the length of the study.
• Parkinson's disease: Hoehn & Yahr stages: I - III (de novo PD patients) OR II - IV (advanced PD patients).
• Never treated with antiparkinsonian medications (de novo PD patients).
• Able to go off of antiparkinsonian medications for a minimum of 14 hours (advanced PD patients), i.e. overnight withdrawal until after the experiments are completed at NIH.

Exclusion Criteria

• Persons with any other medical, surgical, neurological or psychiatric conditions except PD.
• Patients with known symptomatic wearing off. (Wearing-off  Wearing-OffThe process, over time, of medication lasting for fewer and fewer hours, causing the re-emergence of motor symptoms, non-motor symptoms, and autonomic nervous system dysfunction (e.g. sweating and hypersalivation) before the next dose. occurs when the effects of levodopa 'wear off' or diminish before it is time for the next dose.)
• Pregnant women.
• Concurrent use of antidepressants, neuroleptic (anti-psychotic) agents, or any other drugs other than antiparkinsonian medications that could make one more prone to seizures.
• Persons with history of seizure disorder or epilepsy.
• Persons without the capacity to give informed consent.  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.
• If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension.

Enrollment

Expected Enrollment: 24 (US)
Date Enrollment Began: Feb 01 2007
Last Updated Date: Apr 06 2007
Trial Post Date: Apr 06 2007
Website: http://www.clinicaltrials.gov/ct/show/NCT00431366?order=1

Primary Contacts and Locations

Maryland

• Patient Recruitment and Public Liaison Office
  National Institutes of Health  National Institutes of Health (NIH)The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Headquartered in Bethesda Maryland, it is composed of 27 Institutes and Centers and provides leadership and financial support to researchers in every state and throughout the world. Internet address: http://www.nih.gov. Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Center
  prpl@mail.cc.nih.gov
  Phone: (800) 411-1222
  9000 Rockville Pike
  Bethesda, MD 20892
  USA