Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain (NCT04144972) | Clinical Trial Compass
RecruitingNot Applicable
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
United States12 participantsStarted 2019-10-24
Plain-language summary
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 participate
Age range22 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 22-80 years old
✓. Clinical diagnosis of a refractory chronic pain syndrome including
✕. 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