Investigation of the Use of Remote Presence Robots in Delivery of Neuromodulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ivar Mendez, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01283633
First received: January 18, 2011
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

In recent years, robotic devices are becoming more and more common in medical practice. Such devices provide an effective way to communicate within a clinical setting, but recent studies have shown far more diverse uses for these robots, ranging from training future surgeons to diagnoses of patients. In the investigators study, the investigators would like to investigate whether it is effective to employ robotic devices in the administration of neurostimulation treatment. It is the investigators hypothesis that the introduction of robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation treatment protocol. In addition, the investigators also predict a high satisfaction rating from all participants involved in conditions involving the robot.


Condition Intervention Phase
Complications; Neurostimulator
Satisfaction
Device: Neuromodulation
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of the Use of Remote Presence Robots in the Administration of Neuromodulation Treatment

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Patient Satisfaction [ Time Frame: Patients will complete the questionnaire once following the neuromodulation therapy. Day 1 ] [ Designated as safety issue: No ]
    The questionnaire will take approximately 10 minutes to complete. There are no other follow-ups required. This is the only study time commitment for the patients above the usual standard of care.


Secondary Outcome Measures:
  • Nursing satisfaction questionnaire [ Time Frame: Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1. ] [ Designated as safety issue: No ]
    The questionnaire will take approximately 10 minutes to complete. The time commitment from the nurse programmer will be approximately 45 minutes. There are no other test points nor follow up visits.


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: programming with non-experienced nurse
Programming done by an experienced neuromodulation clinician will be compared to the patient satisfaction of a programming session with an inexperienced nurse via remote presence robotics, which will be directed by the experienced clinician
Device: Neuromodulation
Neuromodulation as directed via remote presence robotic and experienced clinician for those with neuromodulation systems implanted to treat movement disorders and chronic pain
Other Names:
  • Neurostimulation
  • deep brain stimulation
  • spinal cord stimulation

Detailed Description:

Patients with neuromodulation systems implanted for either movement disorders or chronic pain and who require programming of their systems will be approached to enter the study. Those who consent will be consecutively assigned to either the normal standard of care (i.e. programming of their systems with an experienced clinician) or programming of their systems with an inexperienced programmer (nurse) who will be directed by the experienced programmer via the remote presence robot. Both the nurses and the patients will complete questionnaires rating their satisfaction of the programming experience.

They will each only receive one questionnaire at the end of the programming session. There is no other test point.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with neuromodulation systems, requiring programming
  • nurses who have never programmed a neuromodulation system before

Exclusion Criteria:

  • those who are unwilling to give consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283633

Locations
Canada, Nova Scotia
Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Ivar M Mendez, MD Capital Health and Dalhousie University
  More Information

No publications provided

Responsible Party: Ivar Mendez, Neurosurgeon, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01283633     History of Changes
Other Study ID Numbers: Robotics-Neuromod-Mendez
Study First Received: January 18, 2011
Last Updated: March 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
neuromodulation
remote presence robotics

ClinicalTrials.gov processed this record on October 21, 2014