[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-pain-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-pain-patients":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100592680","study-to-compare-the-clinical-effectiveness-and-cost-utility-of-an-all-in-one-procedure-with-an-at-home-screening-trial-100592680",false,"NCT06996574","Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial","A Pragmatic Randomised Prospective Multi-centre Non-inferiority Trial in Chronic Pain Patients With Closed-loop Spinal Cord Stimulation (CL-SCS) to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial","All-in-one","Inclusion Criteria:\n\n1. Diagnosed with chronic, neuropathic pain with an approved aetiology in the Netherlands PSPS (persistent spinal pain syndrome) PDN (painful diabetic neuropathy) CRPS (complex regional pain syndrome) SFN (small fibre neuropathy)\n2. Suitable candidate according to the inclusion criteria of the Dutch \"Standpoint on Neuromodulation in Chronic Pain\" Adult patients ≥18 years Chronic pain ≥6 months Pain intensity of ≥50mm or ≥5 on VAS- or NRS-score respectively\n3. Routinely selected for CL-SCS\n4. Be willing to complete additional trial related questionnaires\n5. Be willing and capable of giving informed consent.\n\nExclusion Criteria:\n\n1. General exclusion criteria according to the Dutch \"Standpoint on Neuromodulation in Chronic Pain\":\n\n   Drug abuse Pregnancy Coagulation disorder \u002F Use of anticoagulation therapy which cannot be stopped temporarily Active infection Life expectation ≤12 months Intake questionnaires \"PROMS neuromodulatie\" not completed by the patient\n2. Have an existing drug pump and\u002For SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)\n3. Current or previous treatment with an implanted pain reduction device\n4. Participation in another clinical trial that may confound the results of this trial","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","In 2019, the Dutch Healthcare Institute published a consensus report outlining when spinal cord stimulation (SCS) for chronic pain qualifies for reimbursement under Dutch health insurance. It mandates that adult patients with significant pain (VAS ≥50mm or NRS ≥5) undergo an at-home screening trial, which must show at least 50% pain reduction to proceed with permanent implantation. Screening trials give patients early access to the therapy, but they are expensive, often redundant, and pose risks such as infection. A recent UK study (TRIAL-STIM) found no significant difference in outcomes between patients who had screening trials and those who received an all-in-one SCS procedure, but the trial strategy incurred greater costs. Given these findings, and the fact that all-in-one procedures are already used in certain Dutch cases, it is reasonable to evaluate this approach more broadly. Therefore, a pragmatic, multi-centre, randomized non-inferiority trial will compare the effectiveness of the all-in-one procedure, no trial group (NTG) to the standard two-step approach, trial group (TG) in Dutch patients with chronic neuropathic pain.",[27,28],"Neuromodulation","Chronic Pain Patients",[30,31,32,33],"neuromodulation","chronic pain","SCS procedure","standard of care","RECRUITING","2025-07-06",{"date":37,"type":38},"2025-07-10","ACTUAL",{"date":40,"type":38},"2025-06-06",{"date":42,"type":21},"2028-04-01",{"name":44,"class":45},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100578188","medical-cannabis-and-behavior-100578188","NCT06808048","Medical Cannabis and Behavior","Neurobehavioral Impacts of Medical Cannabis Use: An Observational Study","Inclusion Criteria:\n\n* Medical cannabis users (n=120) will be required to\n\n  1. Be ages 35-65;\n  2. Be qualified for a medical cannabis prescription based only on a diagnosis of chronic pain; note that individuals can, in theory, utilize medical cannabis for more than one qualifying condition. People with orthopedic pain will be prioritized.\n  3. Have normal or corrected-to-normal vision and hearing;\n  4. Be free of current and past DSM-V-defined substance use disorders; have \\\u003C 5 lifetime recreational uses of illicit drugs.\n  5. Have limited daily exposure to nicotine (e.g., no daily smokers\u002Fvapers; use of nicotine products fewer than 5 occasions weekly);\n  6. Willing to abstain from alcohol, nicotine, and other (non-treatment) drugs for 24 hours prior to study. Abstinence will be verified by breathalyzer and urine drug screening; must not test positive on breathalyzer and urine drug screenings for any nonprescribed psychoactive substance or for cannabis (at baseline);\n  7. Must be right handed as assessed by the Edinburgh Handedness Inventory;\n  8. Lifetime use of cannabis \\\u003C 15 times; no cannabis product use (recreational or therapeutic) within the past six months;\n  9. Able to schedule and complete a multi-hour single session protocol;\n  10. Have sufficient manual mobility to be able to complete computerized neurocognitive assessments;\n  11. Able to communicate with the researchers by phone during the four month pre-post assessment interval\n\nPain patients who are not using medical cannabis (n=60) will be required to:\n\n1. Be ages 35-65;\n2. Suffer from a chronic pain condition that could qualify them for medical cannabis; People with orthopedic pain will be prioritized.\n3. Have normal or corrected-to-normal vision and hearing;\n4. Be free of current and past DSM-V-defined substance use disorders; have \\\u003C 5 lifetime recreational uses of illicit drugs.\n5. Have limited daily exposure to nicotine (e.g., no daily smokers\u002Fvapers; use of nicotine products fewer than 5 occasions weekly);\n6. Willing to abstain from alcohol, nicotine, and other (non-treatment) drugs for 24 hours prior to study. Abstinence will be verified by breathalyzer and urine drug screening; must not test positive on breathalyzer and urine drug screenings for any non- prescribed psychoactive substance or for cannabis (at baseline);\n7. Must be right handed as assessed by the Edinburgh Handedness Inventory;\n8. Lifetime use of cannabis \\\u003C 15 times; no cannabis product use (recreational or therapeutic) within the past six months;\n9. Able to schedule and complete a multi-hour single session protocol;\n10. Have sufficient manual mobility to be able to complete computerized neurocognitive assessments;\n11. Able to communicate with the researchers by phone during the four month pre-post assessment interval Within both groups, concomitant opioid use will be allowed as will other prescribed treatments. Controls will be matched to the cannabis group on age, sex, socioeconomic status (SES), type of pain condition (orthopedic pain will be targeted) and comorbid opioid use.\n\nAll potential participants must indicate at the baseline enrollment that they have no immediate plans to relocate from the Twin Cities metro area (e.g., must be willing and able to participate in longitudinal assessment for a four-month period).\n\nExclusion Criteria:\n\n1. Cannot have a degenerative neurological condition or a neurological condition that impacts brain function (e.g., epilepsy);\n2. No contraindications to MRI scanning;\n3. No lifetime history of severe DSM-V psychopathology (psychotic disorders, bipolar disorder); if currently treated mood for anxiety disorders, must be stable;\n4. No current pregnancy or pregnancy within the prior 3 months; cannot be lactating;\n5. No cannabis product use (recreational or therapeutic) within the past six months;","35 Years","65 Years",{"count":20,"type":21},[24],"This study will assess cognition, neural function, and drug exposure in chronic pain patients who have been prescribed medical cannabis and will differentiate outcomes based on use of specific CBD-dominant versus THC-dominant treatment products. This longitudinal study will recruit medical cannabis users from local dispensaries. Each participant will complete a baseline assessment prior to the start of medical cannabis use, monthly phone calls to assess treatment adherence, and a four-month follow- up assessment. The aims of this project are: Aim 1. To assess impacts of medical cannabis compounds on executive functions, learning and memory in adults to determine whether cognitive impairments are evident after the onset of cannabis use; Aim 2. To assess the impacts of medical cannabis compounds on white matter microstructure, functional brain activity and functional connectivity; Aim 3. To differentiate change over four months in these outcomes as a function of (a) age and (b) pre-to-post-treatment changes in blood levels of cannabinoid compounds.",[28,60],"Medical Cannabis Users",[62,63,64,65],"cannabis","medical cannabis","brain MRI","pharmacokinetics","2025-06-27",{"date":68,"type":38},"2025-06-29",{"date":70,"type":38},"2025-06-18",{"date":72,"type":21},"2029-07-31",{"name":74,"class":45},"University of Minnesota"]