protocolSection identificationModule nctId: NCT06387914, orgStudyIdInfo id: PID 16707, secondaryIdInfos id: 23/WM/0219, type: OTHER, domain: Ethics Committee (South Birmingham REC) UK, briefTitle: Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation, acronym: EPIONE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-05-02, completionDateStruct date: 2027-05-02, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, collaborators name: Jon MoultonTrust, collaborators name: Placito Bequest, collaborators name: Bioinduction, descriptionModule briefSummary: The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are:* Does DBS lower the pain score in these participants.* What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain.Participants will:* Undergo baseline screening procedures and have an MRI scan.* Have neurosurgery to put the DBS system in* Have follow up for 10 months* Visit the clinic at least 5 times in the study for check-ups and tests* Fill in questionnaires about pain and mood and have check ups remotely, conditionsModule conditions: Central Post Stroke Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind trial, within subject randomisation and cross-over., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Blinding maintained using the hand held controller (shows ON at all times) and programs which ensure equivalent battery drain at all stimulation settings.Pseudo-ON =high frequency, low amplitude stimulation. Frequency up to 250 Hertz(Hz), Amplitude less than 0.5 milliamps(mA), Pulse Width 500 microseconds(uS)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Stimulation ON, interventions name: Stimulation Pseudo-ON, outcomesModule primaryOutcomes measure: McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score, secondaryOutcomes measure: Numerical Rating Scale (NRS), secondaryOutcomes measure: McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form), secondaryOutcomes measure: Brief Pain Inventory (BPI) - Short Form, secondaryOutcomes measure: Beck Depression Inventory (BDI II), secondaryOutcomes measure: Patients' Global Impression of Change (PGIC), secondaryOutcomes measure: EuroQol Quality of life (EQ5D-5L), secondaryOutcomes measure: Healthy Days Measures (HDM), secondaryOutcomes measure: Adverse Events (AEs), otherOutcomes measure: Heart rate variability (HRV), otherOutcomes measure: Client Service Receipt Inventory (CSRI), otherOutcomes measure: MRI, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False