RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. In a subset of patients we will also perform combined positron emission tomography/magnetic resonance imaging at baseline, week 2 and week 4.

Official Title

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

Quick Facts

Study Start:2023-05-23
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05661903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 to 80
  2. * Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomes
  3. * Stably implanted spinal cord or dorsal root ganglion stimulator
  4. * Device is to treat back/radicular lower extremity pain or neck/arm pain
  5. * Device with a paresthesia-free setting
  1. * Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 MME/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
  2. * The investigator concludes that the participant is unable to differentiate back or neck/arm pain from other pains
  3. * Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial
  4. * 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
  5. * Stimulation device is not 3 Tesla magnetic resonance imaging compliant
  6. * Contraindications to magnetic resonance imaging and/or positron emission tomography scanning (including presence of a cardiac pacemaker or pacemaker wires, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
  7. * Pregnant or breastfeeding
  8. * Participants with a low affinity binder phenotype based off testing for the Ala147Thr polymorphism.
  9. * Current or recent use of benzodiazepines (except for alprazolam, clonazepam, and lorazepam). Recent use will be defined based off the benzodiazepines half-life, such that patients who stopped taking the medication at least five half-lives ago will be considered eligible for scanning.
  10. * Subjects who have exceeded (or would exceed if they were to participate) the yearly amount of allowable radiation, as defined by the Radiation Safety Committee
  11. * In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., unlikely to remain still during the imaging procedures).

Contacts and Locations

Study Contact

Brian Wainger, MD PhD
CONTACT
617-726-8810
BWAINGER@PARTNERS.ORG

Principal Investigator

Brian Wainger, MD PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Brian Wainger, MD PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-05-23
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain