From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects

Chronic Pain Clinical Trial

Official title:

From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661903
• Other study ID #: 2022P001803
• Secondary ID: 1RM1NS128741-01
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: Brian Wainger, MD PhD
• Phone: 617-726-8810
• Email: BWAINGER[@]PARTNERS.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Spinal Cord Stimulator Set to Minimal/No Stimulation Setting
Patients in this intervention group will have their spinal cord stimulator turned off or to the minimal settings possible.
• Usual Care
Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supraexcitability	The primary outcome will be superexcitability (indicating paired pulse facilitation) measured by threshold tracking nerve conduction.	From baseline (enrollment) to six weeks