Recruiting

Observational Study

Sponsor:

Synergy Health Concepts, Inc.

Code:

NCT01593904

Conditions

Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

1. What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS patients and controls.
2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain perfusion and Cerebrospinal flow before and after the procedure on a large number of patients to determine these outcomes

Conditions

Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants

Study ID

NCT01593904

Start date

Jan, 2012

Status verified date

May, 2012

Completion date

Jan, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ability to comprehend the nature of the study, including the risks and benefits
  • Ability to execute an informed consent
  • Males or Females between the ages of 20 and 65 years of age
  • Voluntary agreement to participate in the study: Venous Irregularities, Flow and Perfusion in MS study (VERIFY MS Study)

Exclusion Criteria:

  • Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
  • Any person who has a contraindication to contrast administration.
  • History of claustrophobia
  • Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Frances Debarge- Igoe, RN

(949) 221-0129uscangionurse@gmail.com

John Joseph Hewett, MD

(949) 221-0129jhewett@synergyhealthconcepts.com

Locations

Synergy Health Concepts Inc.

Recruiting

Newport Beach, California, United States, 92660

Contacts

Frances Debarge-Igoe, RN

949-221-0129uscangionurse@aol.com

John Joseph Hewett, MD

(949) 221-0129jhewett@synergyhealthconcepts.com

Principal Investigator:

John Joseph Hewett, MD

More Information

Sponsor

Synergy Health Concepts, Inc.

Last update posted

May 8, 2012

Last verified

May, 2012

Keywords

  • CCSVI, Flow, Perfusion in MS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Synergy Health Concepts, Inc. on 2012-05-08.