Back to resultsFrom Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulator Set to Minimal/No Stimulation Setting
Usual Care
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria: Aged 18 to 80 Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomes Stably implanted spinal cord or dorsal root ganglion stimulator Device is to treat failed back surgery syndrome with back and radicular lower extremity pain Device with a paresthesia-free setting Exclusion Criteria: Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 morphine equivalents/day per day within the two months prior to enrollment, or those who are unwilling to maintain a stable dose of opioids throughout the duration of the study The investigator concludes that the participant is unable to differentiate failed back surgery syndrome pain from other pains, or the primary cause of pain is unrelated to failed back surgery syndrome. Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial Other factor that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial or tolerate the study procedures
Sites / Locations
- Massachusetts General HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with Implanted Devices on Minimal/No Stimulation Settings
Patients with Implanted Devices on Usual Stimulation Settings
Arm Description
Patients in this arm will be randomized to turn off their spinal cord stimulator (or to minimal settings).
Patients in this arm will be randomized to turn on their spinal cord stimulator to their usual stimulation settings.
Outcomes
Primary Outcome Measures
Supraexcitability
The primary outcome will be superexcitability (indicating paired pulse facilitation) measured by threshold tracking nerve conduction.
Secondary Outcome Measures
Full Information
NCT ID
NCT05661903
First Posted
December 14, 2022
Last Updated
June 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT05661903
Brief Title
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Official Title
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter prospective study of patients who currently have stably implanted spinal cord simulators. Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment, and on the final day of study participation, for one hour intervals, in a multi-crossover design.
Detailed Description
The fundamental hypothesis for this study is that spinal cord stimulators modulate the excitability of primary afferent neurons to reduce pain, and that these changes can be detected by measurement of axonal excitability. For the primary outcome, the study investigators will leverage the sensitivity and reproducibility of threshold tracking nerve conduction studies to detect changes in the excitability of thickly myelinated nerve fibers. The study investigators will use microneurography to record directly from primary nociceptive afferents. Finally, the study investigators will perform plasma inflammatory cytokine profiles to measure changes due to spinal cord stimulators. By correlating changes in outcome measurements with subject pain levels during therapeutic versus minimal spinal cord stimulators settings, this study will determine which effects may be mechanistically relevant and which are unrelated to reduction in pain. Thus, this study will use robust, reproducible techniques to define the peripheral, central, and systemic effects of spinal cord stimulators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Implanted Devices on Minimal/No Stimulation Settings
Arm Type
Other
Arm Description
Patients in this arm will be randomized to turn off their spinal cord stimulator (or to minimal settings).
Arm Title
Patients with Implanted Devices on Usual Stimulation Settings
Arm Type
Other
Arm Description
Patients in this arm will be randomized to turn on their spinal cord stimulator to their usual stimulation settings.
Intervention Type
Other
Intervention Name(s)
Spinal Cord Stimulator Set to Minimal/No Stimulation Setting
Intervention Description
Patients in this intervention group will have their spinal cord stimulator turned off or to the minimal settings possible.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.
Primary Outcome Measure Information:
Title
Supraexcitability
Description
The primary outcome will be superexcitability (indicating paired pulse facilitation) measured by threshold tracking nerve conduction.
Time Frame
From baseline (enrollment) to six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 80
Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomes
Stably implanted spinal cord or dorsal root ganglion stimulator
Device is to treat failed back surgery syndrome with back and radicular lower extremity pain
Device with a paresthesia-free setting
Exclusion Criteria:
Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 morphine equivalents/day per day within the two months prior to enrollment, or those who are unwilling to maintain a stable dose of opioids throughout the duration of the study
The investigator concludes that the participant is unable to differentiate failed back surgery syndrome pain from other pains, or the primary cause of pain is unrelated to failed back surgery syndrome.
Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial
Other factor that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial or tolerate the study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Wainger, MD PhD
Phone
617-726-8810
Email
BWAINGER@PARTNERS.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Wainger, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Wainger, MD PhD
First Name & Middle Initial & Last Name & Degree
Marco Loggia, PhD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Freeman, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Gilligan, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
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