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Completed

NCT Number: NCT01283633

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

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.

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Key information

Conditions

Complications; Neurostimulator Behavior Personal Satisfaction Satisfaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromodulation

Device

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

Primary outcomes

  1. Patient Satisfaction

    Time frame: 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 outcomes

  1. Nursing satisfaction questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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