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Official Study Title: Intermittent Theta-Burst 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. (TBS) for the Treatment of Parkinson 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: NCT00753519
Study ID: 080212, 08-N-0212

Summary

This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of Parkinson's disease (PD). TMS is a method of brain stimulation that may be able to change the activity of the nerve cells of the brain. This study will examine the effects of a specific pattern of stimulation called intermittent theta-burst TMS (iTBS), which uses repeated magnetic pulses delivered in short bursts.

People with mild to moderately severe PD who are between 40 and 80 years of age and whose main problems are slow movement and stiffness may be eligible for this study.

Participants undergo the following tests and procedures:

• Random assignment to real or placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. (sham) iTBS treatment.
  
• iTBS sessions (real or sham) four times a week for two consecutive weeks. For this test, the person sits in a comfortable chair. A wire coil is held on the person's scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The person hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm  ArmAny of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more. or leg.
  
• Test of gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. (walk), hand and arm movements before and after each session. The gait test requires walking ten meters (about 30 yards) in the same corridor with the same shoes.
  
• Extended testing. The first and last gait tests (done before starting iTBS and after the eighth session) require coming off any Parkinson's medication for at least 12 hours before the test. On these test days, participants also undergo a clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. examination, short neuropsychological test battery, a computer-based reaction time test and depression and quality-of-life rating scales. These procedures are repeated in a follow-up visit one month after the last session.
  

Study Phase

Phase 1/2
What is a study phase?

Symptoms Addressed: Movement Symptoms

Freeze Attacks,  Freeze AttacksThe sudden loss of ability to move. Loss of Motor Skills, Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Walking/Gait

Time Commitment

• Less than six months

Eligibility

• Minimum Age: 40
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• Men and women aged 40 to 80 years with DOPA-responsive PD
• Must be on a regimen including levodopa.  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain.
• Total dose of levodopa and 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. agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
• Problems with walking, including freezing gait time for a 10-meter distance greater than six seconds or more

Exclusion Criteria

• Any active psychiatric disease or evidence of dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.
• 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  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms.
• 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 treatment.
• Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
• Mentally impaired people having no capacity to provide their own consent
• Unable to walk a 10-meter distance
• More than occasional falls, i.e. daily falls, history of fall(s) with significant injuries, absence of postural response in the while on medication and/or spontaneous loss of balance while off medication

 

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: Sep 2008
Date Enrollment Ends: Jun 2010
Last Updated Date: Sep 28 2009
Trial Post Date: Dec 11 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00753519?term=NCT00753519&rank=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 Center
  prpl@mail.cc.nih.gov
  Phone: (800) 411-1222
  9000 Rockville Pike
  Bethesda, MD 20892
  USA