Investigation of the Use of Remote Presence Robots in Delivery of Neuromodulation
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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 |
- 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.
- 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:
|
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 |
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| Canada, Nova Scotia | |
| Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| 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 May 23, 2013