An interventional study of Spinal Cord Stimulation in Chronic Pain, Intractable Pain and Low Back Pain, sponsored by Boston Scientific Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Device: Spinal Cord Stimulation
Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
Also known as: neurostimulation
Perception Threshold
Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair
Time frame: Programming Visit (up to 15 days post-screening)
| Milestone | Spinal Cord Stimulation |
|---|---|
| Started | 21 |
| Completed | 20 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair
| percent change in perception threshold | Spinal Cord Stimulation |
|---|---|
| Perception Threshold | 157 ± 52 |
Collected over From Informed consent through End of Study Visit (approximately 15 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Cord Stimulation | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
All consented subjects
| Age, Categorical(Participants) | Spinal Cord Stimulation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 11 |
| Sex: Female, Male(Participants) | Spinal Cord Stimulation |
|---|---|
| Female | 11 |
| Male | 10 |
| Race/Ethnicity, Customized(Participants) | Spinal Cord Stimulation |
|---|---|
| Caucasian | 17 |
| Native American | 1 |
| Black, of African Heritage | 2 |
| American Indian or Alaska Native | 1 |
| Region of Enrollment(participants) | Spinal Cord Stimulation |
|---|---|
| United States | 21 |
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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