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Completed

NCT Number: NCT05459324

Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.

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Key information

Conditions

Chronic Pain Autonomic Nervous System Diseases Back Pain Complex Regional Pain Syndromes Failed Back Surgery Syndrome Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical College

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing a spinal cord stimulation procedure for neuropathic pain.
  • have undergone a successful SCS trial and are determined eligible for a permanent SCS implant.
  • Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.-
  • subjects must be able to give informed consent.

Exclusion criteria

  • patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain

Treatment and study plan

HD Study Electrode

Device

The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Primary outcomes

  1. Numeric Rating Scale

    Time frame: 3 months

    Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.

Secondary outcomes

  1. McGill Pain Questionnaire (MPQ)

    Time frame: 3 month

    Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.

  2. Oswestry Disability Index (ODI)

    Time frame: 3 months

    This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.

  3. Pain Catastrophizing Scale (PCS)

    Time frame: 3 months

    Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.

  4. Beck Depression Index (BDI)

    Time frame: 3 months

    This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63

Other outcomes

  1. PainDetect

    Time frame: Baseline

    Ensures patient's pain is neuropathic in nature

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording: Phase II

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Jul 16, 2024

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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