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

Satisfaction Clinical Trial

Official title:

Investigation of the Use of Remote Presence Robots in the Administration of Neuromodulation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283633
• Other study ID #: Robotics-Neuromod-Mendez
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2011
• Last updated: March 9, 2012
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications; Neurostimulator
• Satisfaction

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	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.	Patients will complete the questionnaire once following the neuromodulation therapy. Day 1	No
Secondary	Nursing satisfaction questionnaire	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.	Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1.	No