DBS of the SCC for the Treatment of Medically Refractory... | NCT04085406

NCT04085406

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
UH3NS113661	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Stimulation	Experimental	Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label period) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).	Device: Deep Brain Stimulation of the Subgenus Cingulate Cortex
Sham Stimulation	Sham Comparator	Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label phase) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).	Device: Deep Brain Stimulation of the Subgenus Cingulate Cortex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep Brain Stimulation of the Subgenus Cingulate Cortex	Device	The Abbott Infinity DBS device will be surgically implanted in the bilateral subgenual cingulate cortex to provide electrical stimulation to this region.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline.	The visual analog scale for pain is a continuous horizontal scale of length 100 mm with the extremes of pain expressed on either end (0 = no pain, 10 = worst pain). The change on the VAS from active stimulation compared to baseline and sham stimulation will be calculated.	12 months - the end of the crossover period
Change in at least 50% in pain scores on the Pain Anxiety Symptoms Scale -- Short Form 20 (PASS SF-20) compared to baseline.	The PASS SF-20 score is a composite 20 item score which focuses on fear and anxiety of pain. It includes 4 sections on aspects of pain including cognitive, escape/avoidance, fear and physiological anxiety. All items are rated on a scale from 0 (never) to 5 (always), where higher values indicate worse outcome. Summary scores are calculated by summing assigned items and then by summing the subscales to derive an overall score for a possible total of 100. The change on the PASS from active stimulation compared to baseline and sham stimulation will be calculated.	12 months - the end of the crossover period
At least 10% of study participants to experience one or more significant adverse events (SAEs)	The percentage of subjects with one or more SAEs during the entire study period will be calculated.	18 months - the end of the study

Secondary Outcomes

Measure	Description	Time Frame
Change in dose and/or frequency of opioid analgesic medication use in oral morphine equivalents.	The effect of therapy on reduction in opioid medication intake will be compared to baseline. Opioid use will be converted into morphine milligram equivalents (MME). The MME taken in the preceding month will be calculated using chart review and expressed in MMEs/ day and total MMEs/month expressed as a percentage of the baseline usage calculated as the average MMEs/day and MMEs/month over the previous six months before the start of enrollment. The change from active stimulation compared to baseline and sham stimulation will be calculated.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pain secondary to failed back surgery syndrome (FBSS) as defined by persistent low back pain despite prior surgical interventions.
Self-reported average back pain intensity of greater than 8 out of 10 on the Visual Analog Scale (VAS) documented over greater than 2 years.
Failure to achieve at least 50% pain relief from a trial of spinal cord stimulation (SCS) or less than 50% pain relief after 3 months of SCS therapy or patient refuses/rejects SCS trial
Failure to achieve at least 50% pain relief in response to at least 4 weeks of physical therapy.
Failure to achieve at least 50% pain relief in response to at least 2 percutaneous spinal pain procedures.
Failure to achieve at least 50% pain relief in response to 3 months of opioid therapy (at least 20 MEQ/day) or inability to increase or tolerate opioid therapy due to dose-limiting side effects).
Failure to achieve at least 50% pain relief in response to a 3-month trial of at least one other class of pain medication in addition to opioid therapy or inability to tolerate increasing doses of non-opioid pain medications due to dose-limiting side effects.
Lack of a surgically correctible etiology for the pain as determined by 2 independent neurosurgeons
Age greater than 40 years of age.
Ability to give informed consent in accordance with institutional policies and participate in the 1.5-year follow-up, involving assessments and stimulator adjustments.
Willingness to share unexpected neurological or psychiatric symptoms with study clinicians.

Exclusion Criteria:

Significant neurocognitive impairment (MoCA < 26).
Age > 75 years.
History of implant-related infection.
History of bleeding disorder or immune-compromise.
Psychiatric comorbidity other than depression or generalized anxiety disorder, as determined by MINI International Neuropsychiatric Interview.
Patients with neurological diagnoses that may reduce the response to or increase the risk of DBS including neurodegenerative conditions, severe movement disorders, demyelinating disorders, syringomyelia, epilepsy or history of seizures, history of CNS tumors (spinal and/or cranial), history of serious head injury with loss of consciousness, history of stroke, surgically reversible peripheral pain syndromes including surgically correctable radiculopathy, and severe peripheral neuropathy.
Patients who have undergone spine surgery within the previous 3 months.
Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation, active infection, immunocompromised state or malignancy with < 5 years life expectancy.
Individuals with a currently implanted SCS device.
Individuals with a life expectancy less than 1 year due to any cause.
Individuals involved in an injury claim under current litigation.
Individuals with a pending or approved worker's compensation claim.
Patient living greater than 100 miles from UCLA.
Suicide attempt in the last two years and/or presence of a suicide plan (an answer of Yes to Question C4 in Section C- Suicidality of MINI International Neuropsychiatric Interview).
Alcohol or illicit substance use disorder (other than nicotine) within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
Uncontrolled medical condition including cardiovascular problems and diabetes.
Pregnant or planning to become pregnant.
Use of warfarin or other blood thinners.
Significant structural abnormality on preoperative brain MRI.
Contraindications to MRIs or the need for recurrent body MRIs.
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.
History of prior cranial neurosurgery.
Patients unable to discontinue any existing therapeutic diathermy.
Individuals who are concomitantly participating in another clinical study.

Name	Role	Phone	Extension	Email
Meskereen Tolossa	Contact	310-206-9187		MTolossa@mednet.ucla.edu
Wendy Sia	Contact	3108255610		Wsia@mednet.ucla.edu