Completed

Evaluation and Treatment of Patients With Spinal Vascular Abnormalities

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What is being collected

Data Collection

Who is being recruted

Congenital Abnormalities+12

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 4 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: June 1993
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 2, 1993

Actual date on which the first participant was enrolled.

Spinal Arteriovenous Malformations are rare lesions that frequently effect young patients and adults in their most productive years. They cause progressive myelopathy, ultimately causing paraplegia or quadriplegia if untreated. Because they are rare lesions, experience with treating them in sufficient numbers to permit classification of them, investigation of the pathophysiology of myelopathy, and the introduction of new techniques for treatment has been possible in only a very few centers in this country. One essential element of investigation of them is selective spinal arteriography. Since selective spinal arteriography was first introduced for these lesions here at the NIH in the mid 1960's by Drs. John Doppman and Giovanni DiChiro, the NIH has been such a center of expertise for patients with spinal arteriovenous malformations. Because of this, NIH has been, and is, a national referral center for these patients. However, there has never been an approved protocol at the NIH for investigation or treatment of these patients. The purpose of this proposal is to present a plan of investigation and treatment which will serve as a protocol under which to admit these patients and to permit continued accrual of clinical experience with them that will serve to guide others in the management of these patients.

NCT00001364
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 2, 2017
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

120 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.

Over 4 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

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

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesCentral Nervous System DiseasesFistulaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesPathological Conditions, Signs and SymptomsVascular DiseasesVascular FistulaCardiovascular AbnormalitiesPathological Conditions, AnatomicalVascular MalformationsArteriovenous FistulaArteriovenous MalformationsSpinal Cord Diseases

Criteria

INCLUSION CRITERIA: Adult greater than or equal to 18 years with known or suspected spinal AVM and capacity to provide written informed consent. Child ages 4-18 with known or suspected spinal AVM and with parent/guardian informed consent. EXCLUSION CRITERIA: Unable to tolerate MRI and/or spinal arteriography. Child less than 4 years.

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 Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center