Recruiting

Neurological Testing

Sponsor:

DC2 Healthcare

Code:

NCT02187653

Conditions

Intraoperative Monitoring

Spinal Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.

Conditions

Intraoperative Monitoring

Spinal Diseases

Study ID

NCT02187653

Start date

Sep, 2011

Status verified date

Jul, 2014

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing lumbar or cervical surgery
  • Utilization of IOM
  • Understand and sign informed consent

Exclusion Criteria:

  • There are no specific exclusion criteria

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Lumbar

Patients undergoing lumbar surgery

Cervical

Patients undergoing cervical surgery

Primary outcome measure

  • Change from baseline in Neurological Assessment at 24 hours [ Time Frame: baseline and 24 hours from time of surgery ]
  • Change in Pain Intensity from Baseline at 24 hours [ Time Frame: baseline and 24 hours from time of surgery ]
  • Complications [ Time Frame: At time of surgery ]
  • Change from baseline in Neurological Assessment at 6 weeks [ Time Frame: baseline and 6 weeks ]
  • Change in Pain Intensity from Baseline at 6 weeks [ Time Frame: baseline and 6 weeks ]
  • Complications [ Time Frame: 24 hours after surgery ]
  • Complications [ Time Frame: 6 weeks after surgery ]

Central Contacts and Locations

Central contacts

Christina R Cook, PhD

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

615-712-9574rtyo@dc2healthcare.com

Locations

DC2 Healthcare

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Christina R Cook, PhD

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

615-712-9574rtyo@dc2healthcare.com

More Information

Sponsor

DC2 Healthcare

Last update posted

Jul 11, 2014

Last verified

Jul, 2014

Keywords

  • IOM
  • IONM
  • Intraoperative Monitoring
  • Intraoperative Neuromonitoring
  • Spine
  • Lumbar
  • Cervical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by DC2 Healthcare on 2014-07-11.