Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities

NCT ID: NCT00001364

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1993-06-02
• Study Completion Date: 2007-12-10

Brief Summary

Arteriovenous malformations (AVM) are abnormally formed blood vessels that can be located throughout the brain and spinal cord. Patients with abnormalities of the blood vessels located in and around the spinal cord can develop many neurological problems. Some problems include, weakness, pain, difficulty walking, paralysis, and even death.

The treatment for these AVMs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. The treatment is aimed at stopping the neurologic problems from worsening and possibly correcting the existing problems. There are two commonly used treatments for AVMs, surgery and embolization (blocking off of blood flow to the AVM).

However, researchers have limited experience treating these conditions because they are rare. In addition, it has been difficult to classify different kinds of AVMs and to develop new treatments for them.

This study is designed to increase researchers understanding of AVMs by admitting and following patients diagnosed with the condition. By increasing the amount of patients studied diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new management plans for patients with AVMs.

Detailed Description

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.

Conditions

Arteriovenous Fistula; Arteriovenous Malformation; Spinal Cord Disease

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: lead

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

References

Oldfield EH, Doppman JL. Spinal arteriovenous malformations. Clin Neurosurg. 1988;34:161-83. No abstract available.

Reference Type: BACKGROUND

PMID: 3288393 (View on PubMed)

Other Identifiers

93-N-0151

Identifier Type: -

Identifier Source: secondary_id

930151

Identifier Type: -

Identifier Source: org_study_id