Status:
COMPLETED
Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Chronic Pain
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
Vagus Nerve Stimulation (VNS) is a validated and FDA-approved therapy that has improved the lives of many individuals with epilepsy and depression and has shown promise for treating chronic pain. Howe...
Detailed Description
Testing will occur over the course of 2 2-3 hour study visits. After completing consent forms, participants will complete questionnaires and undergo baseline Quantitative Sensory Testing (QST). After ...
Eligibility Criteria
Inclusion
- age 21-65.
- chronic pain lasting for more than 6 months as the primary complaint.
- typical pain ratings ≥ 3/10 on a visual analogue scale.
- able to speak and understand English.
Exclusion
- evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures.
- history of cardiac or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
- current peripheral neuropathy.
- current pregnancy, or intention to become pregnant during the study.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04053127
Start Date
April 1 2019
End Date
August 1 2020
Last Update
August 31 2022
Active Locations (1)
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1
Robert Edwards
Chestnut Hill, Massachusetts, United States, 02467