- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00063284
Investigating the Safety of srTMS in the Treatment of Parkinson's Disease
Safety Study of the Super Rapid Transcranial Magnetic Stimulation in Patients With 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Testing the safety limit (SL) of 50 Hz srTMS.
Lasso di tempo: Single visit
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Single visit
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Aarsland D, Larsen JP, Waage O, Langeveld JH. Maintenance electroconvulsive therapy for Parkinson's disease. Convuls Ther. 1997 Dec;13(4):274-7.
- 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.
- Belmaker RH, Grisaru N. Magnetic stimulation of the brain in animal depression models responsive to ECS. J ECT. 1998 Sep;14(3):194-205.
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Inizio studio
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 030220
- 03-N-0220
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .