NCT00063284

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 parkinson-disease

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2003

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2003

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2009

Completed
Last Updated

July 2, 2017

Status Verified

April 15, 2009

First QC Date

June 24, 2003

Last Update Submit

June 30, 2017

Conditions

Parkinson Disease

Keywords

Electrical StimulationHuman BrainParkinson DiseasePD

Outcome Measures

Primary Outcomes (1)

  • Testing the safety limit (SL) of 50 Hz srTMS.

    Single visit

Interventions

Magstim Rapid Magnetic StimulatorDEVICE

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be men and women aged 40 to 80 years with DOPA-responsive, akinetic-rigid PD.
  • After obtaining the informed consent, patients will be interviewed and examined by either the prinicipal investigator (PI) or a Brain Stimulation Unit (BSU) or an HMCS physician to establish the diagnosis of PD and rule out any other neurologic condition.
  • Only patients with a Hoehn and Yahr grade of 2 to 4 while 'off' will be accepted.
  • Patients must be on a regimen including L-DOPA, and they must have a total dose of medication equal to more than 300 mg of L-DOPA equivalent, including their dopamine agonist agents.
  • Any patient whose record does not contain a neurological examination from the past year will be reexamined before enrollment.

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Baudewig J, Siebner HR, Bestmann S, Tergau F, Tings T, Paulus W, Frahm J. Functional MRI of cortical activations induced by transcranial magnetic stimulation (TMS). Neuroreport. 2001 Nov 16;12(16):3543-8. doi: 10.1097/00001756-200111160-00034.

    PMID: 11733708BACKGROUND

  • Aarsland D, Larsen JP, Waage O, Langeveld JH. Maintenance electroconvulsive therapy for Parkinson's disease. Convuls Ther. 1997 Dec;13(4):274-7.

    PMID: 9437571BACKGROUND

  • Belmaker RH, Grisaru N. Magnetic stimulation of the brain in animal depression models responsive to ECS. J ECT. 1998 Sep;14(3):194-205.

    PMID: 9773358BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 24, 2003

First Posted

June 25, 2003

Study Start

June 18, 2003

Study Completion

April 15, 2009

Last Updated

July 2, 2017

Record last verified: 2009-04-15

Locations

US(1)