[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592933":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":57,"studyPopulation":44,"armGroups":58,"interventions":70,"overallOfficials":44,"centralContacts":44,"locations":79,"responsibleParty":121,"collaborators":44,"id":124,"slug":44,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":44,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":154,"whyStopped":44,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"National University Health System, Singapore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":44},[9,13],{"measure":10,"description":11,"timeFrame":12},"Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA).\n\nMean change in LE-FMA from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).","From enrollment to Day 90 post intervention (with allowance of + 7 days).",{"measure":14,"description":15,"timeFrame":12},"Functional Independence Measure (FIM)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in functional independence measured using Functional Independence Measure (FIM) score, in stroke patients with hemiplegia or hemiparesis in the subacute stage.\n\nMean change in FIM from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",[17,20,23,26,29,32,35,38,41],{"measure":18,"description":19,"timeFrame":12},"Modified Ashworth Scale (MAS)","Effects of high frequency tPCS + TENS compared to Sham device stimulation +TENS (Control) in lower limb spasticity related to stroke objectively measured using Modified Ashworth scale (MAS).\n\nMean change in MAS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":21,"description":22,"timeFrame":12},"Modified Tardieu Scale (MTS)","Effects of high frequency tPCS + TENS compared to Sham device stimulation +TENS (Control) in treatment of lower limb spasticity related to stroke objectively measured using Modified Tardieu Scale (MTS)..\n\nMean change in MTS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":24,"description":25,"timeFrame":12},"Time Up and Go (TUG)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking speed, objectively measured with Time Up and Go (TUG).\n\nMean change in TUG from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":27,"description":28,"timeFrame":12},"10-meter Walk Test (10MWT)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking endurance objectively measured with 10-meter Walk Test (10MWT).\n\nMean change in 10MWT from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":30,"description":31,"timeFrame":12},"6-minute Walk Test","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking endurance objectively measured using 6-minute Walk Test.\n\nMean change in 6-minute Walk Test from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":33,"description":34,"timeFrame":12},"Berg Balance Scale (BBS)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in balance objectively measured using Berg Balance Scale (BBS).\n\nMean change in BBS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":36,"description":37,"timeFrame":12},"Pain Numeric Rating Scale (NRS)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) on pain using pain numeric rating scale (NRS).\n\nMean change in NRS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":39,"description":40,"timeFrame":12},"EQ5D-5L","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) on quality of life (QOL) measured objectively using EQ5D-5L.\n\nMean change in EQ5D-5L from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",{"measure":42,"description":43,"timeFrame":12},"Hospital Anxiety Depression Scale (HADS)","Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) on mood using Hospital Anxiety Depression Scale (HADS).\n\nMean change in HADS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"RANDOMIZED","PARALLEL","Active tPCS + TENS treatment (Intervention arm) This group will receive active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via 6\\*9cm Silica gel electrodes on top of the tPCS that is delivered through Channel 1. The placement of the electrodes will be on the part of the spinal segment innervating the lower limbs (L1-L5), the adductor muscles and the gastrocnemius muscles.\n\nSham tPCS + TENS treatment (Control arm) Sham tPCS current will be delivered through Channel 1, while active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via surface electrodes. The placement of electrodes will be exactly the same as the active tPCS montage.","TREATMENT",{"masking":51,"maskingDescription":44,"whoMasked":52},"QUADRUPLE",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","In this prospective, double-blind, sham-controlled randomized control study, a total of 90 participants with hemiplegia or hemiparesis post stroke will be recruited from National University Hospital (NUH) and Alexandra Hospital (AH) inpatient wards and outpatient clinic. 45 participants will be randomized to the intervention arm (Intervened with tPCS + TENS) and 45 participants will be randomized to the control arm (Sham device stimulation + TENS).\n\nThe study will consist of a Screening period of up to 14 days. Participants who fulfil all the inclusion criteria will be consented and recruited during this screening period, constituting as Visit 1 (Recruitment). During this visit, PI\u002F Co-I obtaining consent will ensure that patient\u002F caregiver meets the following criteria:\n\n1. For patients where the caregiver is administering the treatment, study team will ensure that they are the primary caregiver of the patient.\n2. Patient\u002F caregiver must be comfortable and committed in following directions for device usage.\n3. Patient\u002F caregiver must not have mental disability.\n\nAfter confirmation of the above criteria, patient\u002F caregiver will undergo a 2-hour hands-on training at NUH by trained study team.\n\nA set of training slides titled \"AscenZ-VIII User training slides\" that is adapted from the standard \"Instruction Manual AscenZVIII\" will be utilized for the training session for patient\u002F caregiver. After which, a checklist titled \"Home Training Checklist\" will be completed by both the trainer and patient\u002Fcaregiver. This checklist is aimed to ensure that all necessary components of training have been covered by the trainer and also for trainers to indicate confidence of patient\u002F caregiver during the training before both trainer and patient\u002F caregiver signs as a form of training acknowledgement.\n\nPost training, a copy of the standard \"Instruction Manual AscenZVIII\" will be given to patient\u002F caregiver. Study team will emphasize to patient\u002F caregiver that they can contact study team at any juncture where they need additional clarifications relating to the device.\n\nDepending on the hospitalization status at time of screening, the patient will be seen in the inpatient ward or specialist outpatient clinic at day 14 which is considered as Visit 2 (Randomization with allowance + 3 days). Allowance of up to 3 days is given in the event day 14 falls on a weekend\u002Flong weekend. Following Visit 2 (Randomization with allowance + 3 days), up to 3 days of habituation for device use and tolerability will take place. Participants will be required to receive the intervention at low levels of intensity to allow conditioning for the habituation period. Because of the nature of the intervention, it may cause some discomfort to the participants, hence conditioning will increase the tolerability of the treatment for the participants.\n\nIntervention with tPCS will take place over 30 days either in the inpatient setting of NUH and AH or in the home setting, while the rehabilitation therapy sessions with physiotherapy and occupational therapy happening concurrently as per existing clinical treatment protocol. Treatment with tPCS and TENS will consist of a daily session of 30 minutes for 30 days. Compliance will be checked by research assistant via telephone or video call interview at regular interval. One group will be randomised to the sham device stimulation + TENS (Control) arm and one group will be randomised to the active device intervention arm (intervened with tPCS + TENS). The sham device stimulation (Control) arm have electrode placement in the exact manner as the treatment arm but receive very little transcranial stimulation such that the output is negligible.\n\nAssessment will be done at the time of recruitment which constitutes as Visit 1 (Recruitment), and again at the Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).\n\nActivities and assessments that are done under research activities include:\n\nVisit 1 (Recruitment)\n\n* Eligibility screening\n* Consent taking\n* Blood Pressure (Research procedure if not done clinically)\n* Standard physio and occupational therapy sessions as prescribed by patient's physician (Research procedure if not done clinically)\n* Stroke deficit scale (Baseline mRS, NIHSS)\n* Clinical measures on lower limb motor function (Lower Extremity - Fugl Meyer Assessment Baseline, Time UP and Go Baseline, 6 Minute Walk Test Baseline, 10 Meter Walk Test Baseline)\n* Clinical measures on lower limb spasticity - Hip, Knee Flexion, Ankle Flexor, Plantar (Modified Ashworth Scale Baseline, Modified Tardieu Scale Baseline)\n* Balance (Berg Balance Scale Baseline)\n* Pain (Pain Numeric Rating Scale Baseline)\n* Mood (Hospital Anxiety and Depression Scale Baseline)\n* FIM\n* EQ5D-5L Baseline\n* Overall length of stay in hospital\n* Outcomes events\u002FComplications\n\nVisit 2 (Randomization with allowance of + 3 days):\n\n* Randomization\n* Commence first day of habituation, up to 3 days\n\nFollow-up Telephone\u002F Video Call Interview, at 2 weeks post intervention (Research procedure)\n\n\\- Patients will be asked regarding: i) Device related side-effects ii) Hospital re-admissions iii) Changes in medications iv) Device management (eg. Difficulties faced while using the device, Device working condition Damage to device, Device parts that require replacement, Re-supply of consumables, etc)\n\nVisit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days):\n\n* Treatment group OR Control Group - 30min daily for 30 days\n* Stroke deficit scale (mRS, NIHSS)\n* Clinical measures on lover limb motor function (Lower Extremity - Fugl Meyer Assessment, Time Up and Go, 6 Minute Walk Test, 10 Meter Walk Test )\n* Clinical measures on lower limb spasticity - Hip, Knee Flexion, Ankle Flexor, Plantar (Modified Ashworth Scale, Modified Tardieu Scale)\n* Balance (Berg Balance Scale)\n* Pain (Pain Numeric Rating Scale)\n* Mood (Hospital Anxiety and Depression Scale)\n* FIM\n* EQ5D-5L\n* Overall length of stay in hospital\n* Outcomes events\u002FComplications\n\nVisit 4 (Final follow-up, Day 90 post intervention with allowance of +\u002F- 7 days):\n\n* Stroke deficit scale (mRS, NIHSS)\n* Clinical measures on lower limb motor function (Lower Extremity - Fugl Meyer Assessment, Time Up and Go, 6 Minute Walk Test, 10 Meter Walk Test)\n* Clinical measures on lower limb spasticity - Hip, Knee Flexion, Ankle Flexor, Plantar (Modified Ashworth Scale, Modified Tardieu Scale)\n* Balance (Berg Balance Scale)\n* Pain (Pain Numeric Rating Scale)\n* Mood (Hospital Anxiety and Depression Scale)\n* FIM\n* EQ5D-5L\n* Overall length of stay in hospital\n* Outcomes events\u002FComplications\n\nManagement of adverse events (AEs and SAEs):\n\nAt recruitment (Visit 1), patients\u002F caregivers will be informed to take note and save research coordinator's contact number stated in the ICF. Patients\u002F caregivers will be reminded to contact research coordinators if patients experience any AE\u002FSAE stated on ICF section 6 from the day of recruitment up to randomization (Visit 2). At randomization (Visit 2) it will again be emphasized to patients and caregivers that they are to continue to monitor for AE\u002FSAE. During the duration of habituation through to the 30-day intervention period, patients\u002F caregivers are additionally required to report to the study coordinators with regards to any discomfort or issues with the device before proceeding with intervention. During the habituation and the 30-day intervention period, study coordinator will be keeping close contact with the patient\u002F caregiver by means of messaging apps to ensure compliance to the treatment regime and for AE\u002FSAE reporting.\n\nPatients who are starting the intervention in the inpatient setting will be monitored by the study team for any adverse events.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Intervention Arm","EXPERIMENTAL","Active tPCS + TENS treatment",[64],"Device: The AscenZ-VIII Stimulator (Investigational Medical Device)",{"label":66,"type":67,"description":68,"interventionNames":69},"Control arm","SHAM_COMPARATOR","Sham tPCS + TENS treatment",[64],[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":44},"DEVICE","The AscenZ-VIII Stimulator (Investigational Medical Device)","Sham tPCS current will be delivered through Channel 1, while active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via surface electrodes. The placement of electrodes will be exactly the same as the active tPCS montage.",[66],{"type":72,"name":73,"description":77,"armGroupLabels":78,"otherNames":44},"This group will receive active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via 6\\*9cm Silica gel electrodes on top of the tPCS that is delivered through Channel 1. The placement of the electrodes will be on the part of the spinal segment innervating the lower limbs (L1-L5), the adductor muscles and the gastrocnemius muscles.",[60],[80,108],{"facility":81,"status":44,"city":82,"state":82,"zip":83,"country":82,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"National University Hospital","Singapore","119228","SG",{"type":86,"coordinates":87},"Point",[88,89],103.85007,1.28967,{"lat":89,"lon":88},[92,97,100,103,106],{"name":93,"role":94,"phone":95,"phoneExt":44,"email":96},"Hariz Halik","CONTACT","+65 9724 9458","hariz_halik@nuhs.edu.sg",{"name":98,"role":94,"phone":95,"phoneExt":44,"email":99},"Sreed Durga Subramaniam","sreesdurgasubramaniam@nuhs.edu.sg",{"name":101,"role":102,"phone":44,"phoneExt":44,"email":44},"Mingxue Jing","PRINCIPAL_INVESTIGATOR",{"name":104,"role":105,"phone":44,"phoneExt":44,"email":44},"Leonard, Leong Litt Yeo","SUB_INVESTIGATOR",{"name":107,"role":105,"phone":44,"phoneExt":44,"email":44},"Sze Chin Jong",{"facility":109,"status":44,"city":82,"state":82,"zip":110,"country":82,"countryCode":84,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Alexandra Hospital","159964",{"type":86,"coordinates":112},[88,89],{"lat":89,"lon":88},[115,116,118,119],{"name":93,"role":94,"phone":95,"phoneExt":44,"email":96},{"name":117,"role":94,"phone":95,"phoneExt":44,"email":99},"Srees Durga Subramaniam",{"name":107,"role":102,"phone":44,"phoneExt":44,"email":44},{"name":120,"role":105,"phone":44,"phoneExt":44,"email":44},"Nicodemus Oey",{"type":102,"investigatorFullName":122,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"JING MINGXUE","Dr Jing Mingxue (Principal Investigator)","100592933",false,"NCT06999876","The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia (COMPENSATOR-Stroke)","The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia: A Double-blind, Sham-controlled, Randomized Controlled Study","COMPENSATOR","Inclusion Criteria:\n\n1. Participants aged 21 years old and below 80 years old with a clinically diagnosed first onset ischaemic stroke confirmed by imaging modalities such as computerised tomography (CT) or magnetic resonance imaging (MRI). Previous transient ischemic attack or clinically silent infarct detected by CT\u002FMRI are not considered as previous stroke.\n2. Participants within the subacute stage of stroke (Within 14 days from stoke onset)\n3. Able to walk with or without assistance\n4. Able to understand instructions and give informed consent\n\nExclusion Criteria:\n\n1. History of craniotomy or placement of implant materials\u002F device in the body that may affect NIBS including, but not limited to, deep brain stimulator, cardiac implant, cochlear implant\n2. Intracranial haemorrhage in the cortical regions\n3. History of epilepsy or seizures\n4. History of major depression and a history of psychotic disorders\n5. Contraindications to tPCS\u002FTENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.\n6. Concurrent use of benzodiazepine pyschoactive class of drugs which may affect effects of tPCS\n7. Concurrent use of anti-seizure medications (ASMs) which may affect effects of tPCS\n8. Presence of significant cognitive impairment\u002F aphasia rendering patient unable to comply with the treatment protocol\n9. Presence of disabling comorbidities that compromises limb function such as orthopaedics or neurological pathologies other than stroke\n10. Previous treatments of the lower limb spasticity with botulinum toxin, or alcohol.\n11. Prior history of non-invasive brain stimulations","ALL","21 Years","79 Years",{"count":135,"type":136},90,"ESTIMATED","INTERVENTIONAL",[139],"NA","The goal of this study is to evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery in stroke patients with hemiplegia or hemiparesis in the subacute stage.The main questions it aims to answer are:\n\nPrimary objective - To evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery, in stroke patients with hemiplegia or hemiparesis in the subacute stage\n\nSecondary Objectives -\n\n1. To evaluate the effects of high frequency tPCS + TENS in treatment of lower limb spasticity related to stroke.\n2. To evaluate the effects of high frequency tPCS + TENS in gait function improvement post stroke, including walking speed, mobility, balance and walking endurance.\n3. To evaluate the effects of high frequency tPCS on pain, mood and QOL.\n\nResearchers will compare the effects of high frequency tPCS + TENS to a control group which involves intervention with Sham device stimulation + TENS.\n\nParticipants will:\n\n* Be identified, recruited and have baseline assessments during screening period\n* First undergo a mandatory 2-hour device training at Visit 2 to ensure device competence.\n* Proceed with up to 7 days of habituation for device use and tolerability.\n* Carry out daily intervention sessions of 30 minutes for 30 days at home or inpatient setting.\n* Phone call follow-up (Telephone\u002F Video Call Interview) 2 weeks post intervention\n* Clinic visit at day 30 post intervention with allowance of + 7 days for study assessments\n* Clinic visit at day 90 post intervention with allowance of +\u002F- 7 days for study assessments\n* Update study coordinators via messaging platforms with regards to device issues, adverse events, any other reporting or questions",[142],"Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage",[144,145,146,147,148,149,150,151,152,153],"Transcranial Pulsed Current Simulation","Transcutaneous Electrical Nerve Stimulation","Lower limb motor function recovery","Spasticity","Gait dysfunction","Standing balance","Ambulation","Stroke","Hemiplegia","Hemiparesis","NOT_YET_RECRUITING","2025-05-23",{"date":157,"type":158},"2025-05-31","ACTUAL",{"date":157,"type":136},{"date":161,"type":136},"2026-12-31",{"name":5,"class":6},2]