Investigating the Safety of srTMS in the Treatment of Parkinson's Disease
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety Study of the Super Rapid Transcranial Magnetic Stimulation in Patients With Parkinson's Disease|
- Testing the safety limit (SL) of 50 Hz srTMS. [ Time Frame: Single visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||April 2009|
Device: Magstim Rapid Magnetic Stimulator
The treatment of Parkinson's disease (PD) needs further improvement, particularly in the areas of gait and freezing. A promising technique is repetitive transcranial magnetic stimulation (rTMS) that, so far, has produced small effects on bradykinesia in drug free patients in limited trials. The relevant rTMS parameters for the therapeutic effect are unknown. Use of very high rTMS frequency (50 Hz, maximum output of the modern TMS machines, super rapid TMS [srTMS] with circular coil design [vs. a figure eight shape]) may further improve the therapeutic effect in people who have PD. The 50 Hz srTMS frequency proposed here is in a range that exceeds the currently established guidelines since such high frequencies have not been investigated. We will look for acute srTMS effects of the primary motor cortex (M1) stimulation (60% to 100% motor threshold [MT] intensity, 0.5 seconds to 2 seconds train duration). A multi-channel electromyography (EMG) record will be visually controlled for signs of increasing time-locked EMG activity, EMG correlates of the spread of excitation through M1, or an increase of M1 excitability to establish the safe superrapid transcranial magnetic stimulation (srTMS) limit. The electroencephalogram (EEG) Record, Folstein Mini-Mental Exam, CFL and FAS Letter Production Test (words beginning with letters 'C', 'F' etc), Serial Reaction Time, Grooved Pegboard Test, and Unified PD Rating Scale (UPDRS) will be done before and after the srTMS session to control possible srTMS side effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063284
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|