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NCT00431366 · ClinicalTrials.gov registry record

Sequence Effect in Parkinson's Disease

A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
24
Enrollment target

NCT00431366: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00431366 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00431366 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
24 participants
Enrollment target

Study Summary

This study will explore sequence effect, a fatigue or tiredness commonly seen in patients 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 (see description below) to measure whether antiparkinsonian medications (levodopa/carbidopa or dopamine) and repetitive transcranial magnetic stimulation (rTMS, see description below) of the brain can improve the symptoms of sequence effect. Patients with early-stage Parkinson's disease who have never taken antiparkinsonian medications and patients with advanced disease may be eligible for this study. Candidates must be 18 years of age or older and right-handed. Participants have five visits to the NIH Clinical Center as follows: * Visit 1 (baseline): Patients have a neurological examination, including brief cognitive function tests, a rating for depression, and two types of ratings for fatigue severity. * Visits 2 through 5 (experimental sessions): Patients who have been taking antiparkinson medication for a long time are asked to not take their medication for about 12 hours (overnight withdrawal) before visits 2 through 5. They are off medication for about 14 hours total (until after the experiments are done). Patients may be admitted to the NIH Clinical Center for the overnight drug withdrawal if necessary. At the start of each session, participants are given either levodopa/carbidopa tablets or placebo (tablets identical in appearance but with no active medication). They perform the modified pegboard test before medication, after medication, and after brain stimulation with rTMS. During two of the sessions, they receive actual brain stimulation, and during the other two sessions they receive sham stimulation, which does not actually stimulate the brain. The modified pegboard test is a computer-based machine with eight pegs. Subjects transfer each peg from a line of holes on the right side to a line of holes on the left side usi

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2007-02-01
Est. Completion 2008-12-24

What the finished NCT00431366 record still lists

NCT00431366 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00431366 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00431366 about?

NCT00431366 is a clinical study titled "Sequence Effect in Parkinson's Disease". This study will explore sequence effect, a fatigue or tiredness commonly seen in patients 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 (see description below) to measure whether antiparkinsonian medic...

What is the current status of trial NCT00431366?

This trial is currently completed. The enrollment target is 24 participants. The study started on 2007-02-01. Estimated completion is 2008-12-24.

Who is sponsoring clinical trial NCT00431366?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00431366, the US trial registry maintained by the National Library of Medicine. NCT00431366 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.