Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063284
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-06-24
Brief Title:
Investigating the Safety of srTMS in the Treatment of Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Safety Study of the Super Rapid Transcranial Magnetic Stimulation in Patients With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2009-04-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Parkinsons 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 Parkinsons 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
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 Parkinsons 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
Detailed Description:
The treatment of Parkinsons 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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0220 | None | None | None |