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

Sponsor
Nova Scotia Health Authority (Other)
Overall Status
Completed
CT.gov ID
NCT01283633
Collaborator
(none)
30
1
1
5.9
5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Neuromodulation
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Use of Remote Presence Robots in the Administration of Neuromodulation Treatment
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Patient Satisfaction [Patients will complete the questionnaire once following the neuromodulation therapy. Day 1]

      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

    1. Nursing satisfaction questionnaire [Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada B3H 1V7

    Sponsors and Collaborators

    • Nova Scotia Health Authority

    Investigators

    • Principal Investigator: Ivar M Mendez, MD, Capital Health and Dalhousie University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ivar Mendez, Neurosurgeon, Nova Scotia Health Authority
    ClinicalTrials.gov Identifier:
    NCT01283633
    Other Study ID Numbers:
    • Robotics-Neuromod-Mendez
    First Posted:
    Jan 26, 2011
    Last Update Posted:
    Mar 12, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Ivar Mendez, Neurosurgeon, Nova Scotia Health Authority

    Study Results

    No Results Posted as of Mar 12, 2012