Clinical trial for Spinal Cord Injuries
Official title Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
ClinicalTrials.gov ID: NCT04144972
What this study is testing
- What it's testing
- This study is testing whether a new brain‑stimulating system can lower chronic pain that has not responded to other care.
- Who it's for
- You may be able to join if you have chronic pain that other treatments haven’t helped and you have one of the listed conditions.
- What's involved
- You would have a tiny device placed in your brain that sends gentle electric signals only when needed. You will go to the clinic for check‑ups and device adjustments.
- Time commitment
- The study lasts several months and includes regular clinic visits for follow‑up.
You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- Age 22-80 years old
- Clinical diagnosis of a refractory chronic pain syndrome including
- post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury)
- postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain)
- postherpetic neuralgia
You likely can't join if
- Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system...
- Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip...
- Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical...
- Active depression (BDI \> 20), Suicide attempt \</= 12 months or imminent suicide risk, or other untreated or uncontrolled psychiatric illness that...
- History of substance abuse in past 3 years
- Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery.
See the full eligibility criteria
Who can join
- Age 22-80 years old
- Clinical diagnosis of a refractory chronic pain syndrome including
- post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury)
- postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain)
- postherpetic neuralgia
- complex regional pain syndrome
- atypical facial pain
- central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain)
- post-radiation plexopathy
- Two or more years or more of medically refractory severe pain
- Average daily pain for the past 30 days reported as \>6 on a 0-10 numeric rating scale (NRS)
- Pain that fluctuates over a range of at least 3 points on the NRS
- 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.
- Lack of a surgically correctible etiology for the pain as determined by 2 independent surgeons
- Ability to speak / read English
- Capable of understanding and providing informed consent
- Absence of significant cognitive impairment - score of 25 or greater on the Montreal Cognitive Assessment (MoCA)
- Successful detection of pain biomarkers or positive symptomatic response to inpatient stimulation trial period if performed.
What rules you out
- 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...
- 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...
- 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...
- 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.
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
- Allergies or known hypersensitivity to materials in the Summit RC+S system
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.