[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603666":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":100,"collaborators":102,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":24,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":24,"enrollmentInfo":117,"targetDuration":24,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":53,"whyStopped":24,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University of Haifa","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Mirror Therapy + real tDCS","ACTIVE_COMPARATOR","Both MT and tDCS neuromodulatory interferences (separately or combined) will consist of 20 sessions, each lasting 20 min, completed during 4 weeks, once daily (excluding weekends). The neuromodulatory interferences will be self-administered by the participants. The first 2 sessions (at the clinic) will include training to familiarize participants (and their primary caregivers) with the procedure and to instruct them on the self-administering techniques that the researchers and others successfully employed. After training, neuromodulatory interferences will be applied either at the clinic (during hospitalization) or at home (after discharge). This approach promotes participants' retention and reduces dropouts, especially when the study constitutes multiple sessions.",[13,14],"Device: Trans Direct-Cranial Stimulation (tDCS)","Behavioral: Mirror therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Mirror Therapy + sham tDCS","SHAM_COMPARATOR","Both MT and tDCS neuromodulatory interferences (separately or combined) will consist of 20 sessions, each lasting 20 min, completed during 4 weeks, once daily (excluding weekends). The sham tDCS will be identical to the real tDCS, except no current will be applied. However, as recommended, during the first and last 30 sec, the current will be ramped up to 1.5 mA and immediately back to 0 to induce scalp sensations similar to those in real tDCS, further supporting blinding",[13,14],{"label":21,"type":22,"description":23,"interventionNames":24},"No-intervention, natural-course group","NO_INTERVENTION","The participants will receive the regular treatment regimen at the rehabilitation center, including physical-therapy and pharmacological treatment, without intervention of Mirror-therapy and tDCS.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DEVICE","Trans Direct-Cranial Stimulation (tDCS)","The tDCS electrodes will be inserted into 5×7 cm (35 cm2) sponges soaked with saline (0.9 M) and placed as follows: anode over the M1 contralateral to the amputated limb (adjusted based on lower\u002Fupper amputation), and cathode over the forehead, contralateral to the anode (ipsilateral to amputated limb). Total stimulation duration will be 20 min, with a rise and decline time of 30 sec and stimulus intensity of 1.5 mA for the real tDCS real. The intensity of 1.5 mA is in the midrange of recommended intensities (1-2 mA) and supports successful blinding. The sham tDCS will be identical to the real tDCS, except no current will be applied. However, as recommended, during the first and last 30 sec, the current will be ramped up to 1.5 mA and immediately back to 0 to induce scalp sensations similar to those in real tDCS, further supporting blinding. The Mini-CT tDCS Stimulator device has been developed for home use and allows double-blind administration.",[9,16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":24},"BEHAVIORAL","Mirror therapy","Participants will be seated with a portable mirror between their limbs so that the unaffected limb is reflected in the mirror. The participants will focus their attention on the reflection in the mirror and perform the following movements: plantarflexion and dorsiflexion and inversion and eversion of the foot, flexion and extension of the wrist and ulnar and radial deviation, for lower and upper limp amputates, respectively. The participants will continue performing the 2 sets of movements for 20 minutes (with short intermissions if needed)",[9,16],[37],{"name":38,"affiliation":39,"role":40},"Roi Treister, PhD","University of Haifa Faculty of Social Welfare and Health Sciences","STUDY_DIRECTOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":24,"email":45},"CONTACT","+972533839935","rtreister@univ.haifa.ac.il",{"name":47,"role":43,"phone":48,"phoneExt":24,"email":49},"Shlomit Sorek, BPT MPT","+972-0507324111","sorekshlomit@gmail.com",[51,72,87],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":55,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Loewenstein Hospital","RECRUITING","Raanana","Israel","Ahuza 278","IL",{"type":59,"coordinates":60},"Point",[61,62],34.87386,32.1836,{"lat":62,"lon":61},[65,69],{"name":66,"role":43,"phone":67,"phoneExt":24,"email":68},"Hadara Minster-Segev, Ms.","+97250-8428855","LvHelsinki@clalit.org.il",{"name":70,"role":71,"phone":24,"phoneExt":24,"email":24},"Nitza Segal, NP","PRINCIPAL_INVESTIGATOR",{"facility":73,"status":53,"city":74,"state":55,"zip":24,"country":55,"countryCode":57,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Reut Medical Center","Tel Aviv",{"type":59,"coordinates":76},[77,78],34.78057,32.08088,{"lat":78,"lon":77},[81,85],{"name":82,"role":43,"phone":83,"phoneExt":24,"email":84},"Zoya Katzir, Ms.","+972-5486921","Zoya.Katzir@reuth.org.il",{"name":86,"role":71,"phone":24,"phoneExt":24,"email":24},"Simon Levi, MD",{"facility":88,"status":89,"city":74,"state":24,"zip":24,"country":55,"countryCode":57,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Sheba Medical Center","NOT_YET_RECRUITING",{"type":59,"coordinates":91},[77,78],{"lat":78,"lon":77},[94,98],{"name":95,"role":43,"phone":96,"phoneExt":24,"email":97},"Nofar Fuorman","0544764884","nofar.fourman@sheba.health.gov.il",{"name":99,"role":71,"phone":24,"phoneExt":24,"email":24},"Oren Barzel, MD",{"type":101,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[103,104,106],{"name":52,"class":6},{"name":105,"class":6},"Reuth Rehabilitation Hospital",{"name":88,"class":107},"OTHER_GOV","100603666","preventing-chronification-of-phantom-limb-pain-through-mirror-therapy-in-conjunction-with-tdcs-100603666",false,"NCT07139483","Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS","Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* Adults (age ≥18);\n* Amputation of a single limb ≤12 weeks ago; during this period of time, 80% of amputees develop PLP. Both upper and lower limb amputees are included to increase feasibility;\n* Acute PLP stage (2 weeks since first report), with intensity ≥3 on a 0-10 VAS;\n* No change in medication in past week, excluding pro re nata analgesics;\n* Can understand the study's purpose and instructions;\n* Agrees to participate and to provide written informed consent.\n\nExclusion Criteria:\n\n* Stump wound not healed;\n* Other psychological, psychiatric, or neurological conditions;\n* Contraindications for tDCS or magnetic resonance imaging (MRI) (MRI data will not be analyzed in the proposed PhD project), including previous seizure, loss of consciousness due to head injury, metal in the head, implanted devices, claustrophobia, a skin condition or an unhealed wound on the scalp, and possibility of being pregnant;\n* Inability to provide informed consent or understand or carry out the experiment.","ALL","18 Years",{"count":118,"type":119},108,"ESTIMATED","INTERVENTIONAL",[122],"NA","Background: Most amputees experience phantom limb pain (PLP), for years after amputation. Virtually all PLP research to date has focused on the mechanisms of chronic PLP, ignoring the mechanisms of chronification. This research project will focus on combined neuromodulatory interventions of mirror therapy (MT) and trans direct-cranial stimulation (tDCS), applied for the first time at the acute state of PLP, with an aim to prevent its chronification and chronicity. In PLP, maladaptive plasticity associated with sensory deafferentation following an amputation is one of the contributors for excessive pain.\n\nMT is a well-accepted yet limited option, which is thought to counterbalance abnormal plasticity. tDCS is an emerging approach believed to affect the membrane potential and activity threshold of cortical neurons. tDCS analgesic effectiveness, however, is mild and short, rendering it a noneffective stand-alone treatment. The researchers' objectives are to investigate whether the combined therapy of MT and tDCS will prevent chronic PLP and improve its related clinical characteristics. In addition, the researchers will investigate the behavioral manifestations effects of the combined treatment. The investigators expect that the combined treatment applied at the acute stage of PLP will have synergistic effects on PLP intensity and thus avert its chronification. In addition, it will reduce phantom sensations, and negative affect, and will improve the sense of body ownership and agency and endogenous inhibition efficiency.\n\nResearch design: This randomized-controlled double-blinded study will be held at Israel's 3 largest rehabilitation centers. The study consists of 3 randomized patient arms (36 in each): (1) no-intervention, natural-course group; (2) MT + sham tDCS; (3) MT + real tDCS.\n\nMT and tDCS neuromodulatory interferences will be self-administered and consist of 20 sessions, completed during 4 weeks. The researchers outcome measures include: primary outcome: pain intensity, network-related behavioral markers, and amputation-related clinical characteristics. The data gathered will be collected at 5 timepoints.\n\nResearch novelty and innovation: The researchers proposed model will provide insights on the prevention of PLP and, potentially, other neurological pathologies involving the dysfunction of sensory systems and integration and body perception.",[125],"Phantom Limb Pain After Amputation",[127,128,129,130,131,132,133,134],"PLP","Phantom sensation","telescoping","amputation","tDCS","MT","Maladaptive plasticity","Phantom Limb Pain","2025-09-01",{"date":137,"type":138},"2025-09-08","ACTUAL",{"date":140,"type":138},"2025-03-25",{"date":142,"type":119},"2029-03",{"name":5,"class":6},3]