From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Recruiting
Phase 2
Interventional Study
Chronic Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 180 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
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 combi…
Trial Locations
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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 back/radicul…
Contacts