Who is eligible for clinical trial NCT04144972?

Participants must meet the protocol's inclusion criteria for Spinal Cord Injuries. The stated age range is 22 Years to 80 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04144972 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain (NCT04144972)

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of California, San Francisco

🩺 Plain-English Summary (8th-Grade Level)

Chronic pain affects 1 in 4 US adults, and many cases are resistant to almost any treatment. Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but traditional approaches target only brain regions involved in one aspect of the pain experience and provide continuous 24/7 brain stimulation which may lose effect over time. By developing new technology that targets multiple, complimentary brain regions in an adaptive fashion, the investigators will test a new therapy for chronic pain that has potential for better, more enduring analgesia.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (15 items).

Location: University of California, San Francisco — San Francisco, California

Age range: 22 Years to 80 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system failure, active infection or history of implant related infections, immunocompromised state or malignancy with \< 5 years life expectancy
Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators not compatible with RC+S system
Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
Active depression (BDI \> 20), Suicide attempt \</= 12 months or imminent suicide risk, or other untreated or uncontrolled psychiatric illness that evaluating psychiatrist would recommend exclusion of patient after neuropsychiatric evaluation.
History of substance abuse in past 3 years
Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery.
Implantable hardware not compatible with MRI or with the study.
MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
Previous cranial ablative surgery.
Previous deep brain stimulation surgery using an RC+S incompatible system
Major neurological disorder other than the one that led to the chronic pain including epilepsy or a neurodegenerative condition including inability to recharge the device.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of California, San Francisco — San Francisco, California

📞 Contact the Study Coordinator

Phone: (415) 353-3494

Email: chronicpain@ucsf.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗