RECRUITING

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

Conditions

Spinal Cord Injuries Nerve Injury Pain, Postoperative Post Herpetic Neuralgia Complex Regional Pain Syndromes Post-Stroke Pain Post Radiation Brain Injury Post Radiation Plexopathy Nerve Root Avulsion Chronic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-10-24

Study Completion:2030-10-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04144972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 22-80 years old 2. Clinical diagnosis of a refractory chronic pain syndrome including 1. post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury) 2. postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain) 3. postherpetic neuralgia 4. complex regional pain syndrome 5. atypical facial pain 6. central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain) 7. post-radiation plexopathy 3. Two or more years or more of medically refractory severe pain 4. Average daily pain for the past 30 days reported as \>6 on a 0-10 numeric rating scale (NRS) 5. Pain that fluctuates over a range of at least 3 points on the NRS 6. Patient has failed at least two pain medications from different classes as determined by a neurologist or pain management specialist with stable doses of medications for 30 days prior to baseline visit. 7. Lack of a surgically correctible etiology for the pain as determined by 2 independent surgeons 8. Ability to speak / read English 9. Capable of understanding and providing informed consent 10. Absence of significant cognitive impairment - score of 25 or greater on the Montreal Cognitive Assessment (MoCA) 11. Successful detection of pain biomarkers or positive symptomatic response to inpatient stimulation trial period if performed.	1. 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 2. 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 3. Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure. 4. 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. 5. History of substance abuse in past 3 years 6. Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery. 7. Implantable hardware not compatible with MRI or with the study. 8. MR abnormalities that suggest an alternative diagnosis or contraindicate surgery 9. Previous cranial ablative surgery. 10. Previous deep brain stimulation surgery using an RC+S incompatible system 11. 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. 12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) 13. Allergies or known hypersensitivity to materials in the Summit RC+S system 14. Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.

Inclusion Criteria

Exclusion Criteria

1. Age 22-80 years old
2. Clinical diagnosis of a refractory chronic pain syndrome including
1. post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury)
2. postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain)
3. postherpetic neuralgia
4. complex regional pain syndrome
5. atypical facial pain
6. central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain)
7. post-radiation plexopathy
3. Two or more years or more of medically refractory severe pain
4. Average daily pain for the past 30 days reported as \>6 on a 0-10 numeric rating scale (NRS)
5. Pain that fluctuates over a range of at least 3 points on the NRS
6. Patient has failed at least two pain medications from different classes as determined by a neurologist or pain management specialist with stable doses of medications for 30 days prior to baseline visit.
7. Lack of a surgically correctible etiology for the pain as determined by 2 independent surgeons
8. Ability to speak / read English
9. Capable of understanding and providing informed consent
10. Absence of significant cognitive impairment - score of 25 or greater on the Montreal Cognitive Assessment (MoCA)
11. Successful detection of pain biomarkers or positive symptomatic response to inpatient stimulation trial period if performed.

1. 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
2. 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
3. Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
4. 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.
5. History of substance abuse in past 3 years
6. Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery.
7. Implantable hardware not compatible with MRI or with the study.
8. MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
9. Previous cranial ablative surgery.
10. Previous deep brain stimulation surgery using an RC+S incompatible system
11. 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.
12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
13. Allergies or known hypersensitivity to materials in the Summit RC+S system
14. Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.

Contacts and Locations

Study Contact

Catherine Borror

CONTACT

‪(415) 691-7587‬

chronicpain@ucsf.edu

Prasad Shirvalkar, M.D., Ph.D

CONTACT

‪(415) 691-7587‬

Prasad.Shirvalkar@ucsf.edu

Principal Investigator

Prasad Shirvalkar, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Edward Chang, M.D.

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Philip Starr, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Prasad Shirvalkar, M.D., Ph.D, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Edward Chang, M.D., PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Philip Starr, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-24

Study Completion Date2030-10-24

Study Record Updates

Study Start Date2019-10-24

Study Completion Date2030-10-24

Terms related to this study

Keywords Provided by Researchers

Chronic Pain

Additional Relevant MeSH Terms

Spinal Cord Injuries
Nerve Injury
Pain, Postoperative
Post Herpetic Neuralgia
Complex Regional Pain Syndromes
Post-Stroke Pain
Post Radiation Brain Injury
Post Radiation Plexopathy
Nerve Root Avulsion