Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham
About this trial
The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female, age 18-89
Chronic pain for more than 3 months
Willing to visit a research lab
Willing to undergo a blood draw
Disqualifiers
History of neurological disease (e.g., dementias, Parkinson's)
History of stroke
Current diagnosis of cancer
Subject is unwilling or unable to comply with the protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Permanent Epidural Spinal Cord Stimulation
DevicePermanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Arterial Blood Pressure Change
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Time frame
Baseline (1 week pre-op)2
Arterial Blood Pressure Change
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Time frame
Visit 2 (4-6 weeks post-op)Sponsors and contacts
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Source ClinicalTrials.gov