Paresthesia-Free Fast-Acting Subperception (FAST) Study (NCT04618471) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Paresthesia-Free Fast-Acting Subperception (FAST) Study
United States177 participantsStarted 2021-02-10
Plain-language summary
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
* 22 years of age or older when written informed consent is obtained
* Able to independently read and complete all questionnaires and assessments provided in English
* Signed a valid, IRB-approved informed consent form (ICF) provided in English
Key Exclusion Criteria:
* Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes
* Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study