Active DBS for Chronic Pain
Phase-Based Progress Estimates
Effectiveness
Safety
Chronic Pain+5 More
Medtronic Activa PC+S - DeviceEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new way to provide deep brain stimulation (DBS) for people with chronic pain that has not been relieved by other treatments. DBS involves surgically placing a small device in the brain that sends electrical signals to specific areas. The goal of this trial is to find out whether DBS is more effective when it is turned on only when needed, rather than continuously.
Eligible Conditions
- Chronic Pain
- Pain
- Post Stroke Pain
- Spinal Cord Injuries
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 2 years
2 years
Activity Tracker (Fitbit) - Activity (Sleep)
Activity Tracker (Fitbit) - Activity (Steps)
Activity Tracker (Fitbit) - Heartrate
Becks Anxiety Inventory
Mental Depression
NIH PROMIS toolbox (Patient Impression)
Neuropathic Pain Questionnaire
Pain medication usage
Quantitative Sensory Testing Pain Threshold
Short Form 36 Health Survey
Visual Analog Score
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Active DBS
1 of 2
Inactive DBS
1 of 2
Active Control
Non-Treatment Group
10 Total Participants · 2 Treatment Groups
Primary Treatment: Active DBS · Has Placebo Group · N/A
Inactive DBS
Device
ShamComparator Group · 1 Intervention: Medtronic Activa PC+S · Intervention Types: DeviceActive DBS
Device
ActiveComparator Group · 1 Intervention: Medtronic Activa PC+S · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
United States Department of DefenseFED
767 Previous Clinical Trials
202,231 Total Patients Enrolled
8 Trials studying Chronic Pain
2,470 Patients Enrolled for Chronic Pain
University of California, San FranciscoLead Sponsor
2,262 Previous Clinical Trials
11,470,094 Total Patients Enrolled
10 Trials studying Chronic Pain
811 Patients Enrolled for Chronic Pain
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,250 Previous Clinical Trials
452,343 Total Patients Enrolled
7 Trials studying Chronic Pain
737 Patients Enrolled for Chronic Pain
Prasad Shirvalkar, MD, PhDLead Sponsor
Edward Chang, M.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Chronic Pain
10 Patients Enrolled for Chronic Pain
Prasad Shirvalkar, M.D., Ph.D.Principal InvestigatorUniversity of California, San Francisco
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:site
The text is about MRI scans for people with spinal cord injuries
not required
This notice is to inform the public that the ability to speak or read English is not required for the position
This means that the person understands what they are consenting to, and also has all the information they need in order to make an informed decision.
The text discusses different types of pain that can be experienced after a stroke or spinal cord injury
nerves, is an appropriate preoperative workup
A preoperative MRI done within one year that doesn't show any abnormalities near the target nerves is appropriate for someone who is experiencing Phantom limb pain.
For patients with post-stroke pain who have an ischemic stroke, the MRI must show a lesion in the contralateral brainstem, thalamus, or cortex
The average pain reported over the past thirty days is greater than five on a 0-10 numeric rating scale.
The patient has not responded adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic, with current stable doses of medications.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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