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View Clinical Trial (Medical Research Study)
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50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease - NCT00977184-20892 (Clinical Trial 331074)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy331074.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Parkinson Disease |
| Purpose: |
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Background:
- In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic
field which induces an electric current in the brain leading to a change in the
activity of brain cells. There are different effects on the brain with different rates
of stimulation. In a previous study in people with Parkinson's disease, repetitive TMS
(rTMS) given at a particular rate temporarily improved their ability to walk. A faster
rate of rTMS may be more effective in treating symptoms than the rate originally used.
- This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the
people in this study will have active rTMS; the other half will have no brain
stimulation with rTMS.
Objectives:
- To see if a faster rate of transcranial magnetic stimulation is a more effective treatment
for the symptoms of Parkinson's disease than the slower rates that have been studied.
Eligibility:
- Individuals between 40 and 80 years of age who have been diagnosed with mild or
moderate Parkinson's disease.
- Participants must currently be taking Sinemet or dopamine agonists drugs (e.g.,
bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and
rotigotine), and are willing to continue their same treatments for the duration of the
study.
Design:
- This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks.
Participants can also be admitted and stay as an inpatient in the NIH Clinical Center
for the entire study period (for the 10 visits during the first weeks and the follow-up
visit a month later).
- Initial visit will consist of a physical examination; a test of participants' time to
walk 10 meters; and questions about memory, mood, and quality of life. Participants
should not take Parkinson's disease medications for 12 hours before this visit; once
the examinations and tests are complete, participants will be able to take the
medications. Researchers will repeat the tests 1 hour after participants take the
medication.
- TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation
session will last half an hour. Half of the participants will receive active TMS; the
other half will receive sham TMS.
- The first 10 participants will have additional tests to study the safety of rapid TMS
in patients with Parkinson's disease.
- A day after completing the last TMS session, participants will repeat the same tests as
the first visit before and after taking their medication as in the first assessment and
respond to questions about mood, memory, and quality of life.
- One month after completing the last TMS session, participants will repeat the same
tests as the first visit before and after taking their medication.
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| Study summary: |
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Objective:
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz
rTMS (repetitive transcranial magnetic stimulation) and its safety in Parkinson's Disease
(PD) patients.
Study population:
Up to 30 PD patients in Hoehn and Yahr disease stage 2-4 while off medication will be
enrolled. Patients must be receiving more than 300 mg of levodopa (including dopamine
agonists) and have gait problems.
Design:
This is a randomized, double-blind, placebo (sham)-controlled study of 30 patients with PD
in 2 groups (real versus sham stimulation). The study involves performance (8
interventions) of 50 Hz rTMS with large circular coil over the motor cortex on both sides of
the brain. Assessment of PD symptoms with standard tests of motor function will be performed
over a one-month period.
Outcome measure:
The primary endpoint is change in gait speed as assessed by the time it takes to walk 10
meters.
Secondary endpoints include changes in bradykinesia as assessed by measuring the time it
takes to do ten combined hand and arm movements, and changes in total and motor UPDRS
(Unified Parkinson's Disease Rating Scale) score. |
| Criteria: |
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- INCLUSION CRITERIA:
Men and women aged 40 to 80 years with DOPA-responsive PD
Hoehn and Yahr grade of 2 to 4 while off
Must be on a regimen including levodopa
Total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal
to or more than 300 milligrams per day
problems with walking and gait time for a 10-meter distance greater than six seconds or
more
EXCLUSION CRITERIA:
Any active psychiatric disease
History of seizures and epilepsy
Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or
illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold
except for SSRI
Pallidotomy, implanted electrodes and generator for deep brain stimulation
Pregnancy
Surgically or traumatically implanted foreign bodies such as a pacemaker, implanted
medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the
skull or eyes (other than dental appliances or fillings) that may pose a physical hazard
during TEP.
Study would cause undue risk or stress for reasons such as tendency to fall, excessive
fatigue, general frailty, or excessive apprehensiveness.
Dementia as assessed by the Folstein's Mini-Mental Test Examination (MMSE less than or
equal to 24/30) or mentally impaired patients having no capacity to provide their own
consent (the physician establishing the diagnosis and applying UPDRS will evaluate
patient's mental capacity using conventional clinical interview)
Unable to walk a 10-meter distance.
More than occasional falls, i.e. daily falls (corresponding to a score greater than or
equal to 3 and more in UPDRS item 13), history of fall(s) with significant injuries,
absence of postural response in the on and/or spontaneous loss of balance in the off
condition (corresponding to a score of greater than or equal to 2 and greater than or
equal to 3 in on/off condition, respectively, in UPDRS item 30)
Pregnancy is unusual in patients with PD, grade 2-4. Urine sample for the pregnancy test
will be obtained in patients of childbearing potential prior to starting the 50 Hz rTMS
and also at the initial interview after signing the consent form. Women of childbearing
potential will be asked to take appropriate measures to prevent a pregnancy during the
study. |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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