Completed

Drug Refractory Partial Epilepsy, A Therapeutic Trial With Transcranial Magnetic Stimulation

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What is being collected

Device Data

+ device Data

Device
Who is being recruted

Brain Diseases+6

+ Central Nervous System Diseases

+ Epilepsy

See all eligibility criteria
How is the trial designed

Observational
Study Start: March 1997
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1997

Actual date on which the first participant was enrolled.

The purpose of this protocol is to study the effects of transcranial magnetic stimulation (TMS) at 1 Hz on the excitability of the seizure focus in patients with poorly controlled epilepsy refractory to pharmacological treatments. 1 Hz TMS is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex.

NCT00001666
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesEpilepsyNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEpilepsies, PartialSeizures

Criteria

Age 5 to 60 at entry to protocol. History of partial or Complex Partial Epilepsy for two or more years. Patients should be on a stable anti-convulsant regimen defined as unchanged medicines and dose modifications lower than 20% in the last month. Blood levels of anti-convulsants will be measured at the beginning of the study, prior to stimulation and after the study to assure that the type and dose of medication will remain constant. Seizures not completely responsive to medical treatment (1 or more seizures per week for at least 6 months) and patients have failed at least two anti-convulsant regimens in the past. The patients have a localized seizure focus. Epilepsy refractory to medical treatments. No pregnant women (will be tested with urine pregnancy test). No severe coronary disease. No metal anywhere in the cranium except the mouth. No intracardiac lines. No increased intracranial pressure as expressed by the presence of papilledema. No cardiac pacemakers. Must not be taking neuroleptic or antidepressant medications. No progressive neurologic disease.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, United StatesOpen National Institute of Neurological Disorders and Stroke (NINDS) in Google Maps
CompletedOne Study Center