Investigating the Safety of srTMS in the Treatment of Parkinson's Disease

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

Super rapid transcranial magnetic stimulation (srTMS) is a method of brain stimulation that may be able to change the electrical activity of the nerve cells of the brain. It has been proposed and tested as a treatment for brain disorders, including Parkinson's disease. The purpose of this study is to use a device called the magnetic stimulator to investigate the safe limit of srTMS, such as intensity of stimulation and the number of magnetic pulses that may lead to excessive brain stimulation. Ten patients with Parkinson's disease-whose main problems are slowness of movement and difficulty walking-will participate in this study. They will be asked to come to the laboratory for one experiment. Before and after srTMS treatment, investigators will test participants' brain function with a series of psychological tests and an EEG (electroencephalogram). The srTMS treatment is performed by placing an insulated coil of wire on the scalp and passing a very brief electrical current through the wire coil. The experiment will last 2 to 4 hours.

Key facts

Study ID

NCT00063284

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

10

Starts

2003-06-18

Expected to finish

2009-04-15

Last updated by the study team

2017-07-02

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, or concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
• Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, or any implanted stimulators, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation will also be excluded.
• Most of these exclusions also come under the category of significant medical illness. Patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general fatigue, general frailty, or excessive apprehensiveness will also be excluded.
• A urine sample for the pregnancy test will be obtained from any women of childbearing potential prior to the start of srTMS, on the day of the initial interview and signing of the consent form. Pregnant women will be excluded from the study.
• Mentally impaired patients who have no capacity to provide their own consent will be excluded from the study.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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