[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Psychiatry and Neurology, Warsaw\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100462590","effects-of-neuronavigated-theta-burst-stimulation-in-therapy-of-post-stroke-aphasia-100462590",false,"NCT05303649","Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia","Inclusion Criteria:\n\n* First-ever left middle cerebral artery ischemic stroke (brain damage localization confirmed by magnetic resonance imaging, MRI)\n* 3 or more months from the onset of stroke\n* Non-fluent aphasia (confirmed in the BDAE test) with functional communication difficulties ranging from mild to significant (grades from 2 to 4 in ASRS), marked difficulties in naming, and relatively preserved everyday speech comprehension\n* Native Polish speaker\n* Right-handedness prior to stroke\n* Signing of the informed consent for the participation in the study.\n\nExclusion Criteria:\n\n* Psychiatric and\u002For neurological comorbidity (e. g. dementia, depressive disorder, alcohol dependence)\n* Diagnose of epilepsy or epileptic changes in EEG, also frequent losses of consciousness of unclear etiology which might suggest epileptic seizures\n* History of any neurosurgical procedure around the head area\n* 1.5 T MRI examination contraindications (metal elements in the body, e. g. implantable cardioverter-defibrillator, deep brain stimulation devices; claustrophobia)\n* Regular intake of medication that could affect cortical excitability (e. g. antiepileptic or antipsychotic drugs, antidepressants, benzodiazepines) or medication influencing neuroplastic processes (e. g. dopamine)\n* Significant cognitive impairment limiting patient's cooperation during assessment and behavioral aphasia therapy\n* Visual deficits significantly hindering the perception of therapeutic tasks presented visually on a computer's screen\n* New neurological episode (e. g. another brain stroke) or somatic illness (e. g. COVID-19) during the cycle of the therapy, requiring its interruption.","ALL","18 Years","75 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"NA","Aphasia is an impairment in the ability to express and\u002For understand language, commonly observed after stroke to the language dominant (left) hemisphere. Despite natural tendency to spontaneous functional recovery in the first months post stroke and language improvement due to application of behavioral speech and language therapy (SLT), many aphasic patients do not achieve satisfactory level of verbal communication. The aim of the planned study is to explore the potential of the noninvasive repetitive Transcranial Magnetic Stimulation (rTMS) as a therapeutic tool for aphasia in addition to traditional behavioral therapy. In case of aphasia, studies on therapeutic effectiveness of rTMS aim to increase the activity of the language-dominant left cerebral hemisphere, which may be achieved in an indirect manner by inhibiting the activity of the opposite (right) hemisphere or in a direct manner by increasing the excitability of preserved language areas in the left hemisphere. In our study, we plan to administer the newest form of rTMS called Theta Burst Stimulation (TBS), which is safer than the conventional rTMS, even when used in the perilesional area. Computer-based neuronavigation system will be implemented to precisely localize stimulation targets, control administration of stimuli during rTMS sessions, and evaluate differences between participants regarding deviations from established stimulation points. 45 patients (all right-handed, polish native speakers, aged 18-75 years, diagnosed with non-fluent aphasia) will be enrolled in a randomized, double-blind, sham-controlled trial. Subjects will be randomly assigned to one of the three groups: 1) a group with excitatory intermittent TBS of the left hemisphere (iTBS group), 2) a group with inhibitory continuous TBS of the right hemisphere (cTBS group), 3) a group with sham TBS (sTBS group as a control group). Specific forms of stimulation will be carried out for three consecutive weeks (Monday to Friday; a total of 15 stimulation sessions). Immediately after each session of the stimulation, patients will undergo individual SLT. Assessment of language functioning will be carried out three times: before and after the therapy period, and 3 months after its completion. Results of the study will broaden knowledge about hemispherical mechanisms of language and speech recovery after stroke and provide insight into possibilities of their modulation for the purpose of post-stroke rehabilitation.",[26,27],"Stroke, Ischemic","Aphasia Non Fluent",[29,30,31,32,33,34],"Aphasia","Stroke","Theta Burst Stimulation","Therapy","Rehabilitation","Noninvasive Transcranial Brain Stimulation","RECRUITING","2026-03-26",{"date":38,"type":39},"2026-03-31","ACTUAL",{"date":41,"type":39},"2022-09-02",{"date":43,"type":20},"2027-12",{"name":45,"class":46},"Institute of Psychiatry and Neurology, Warsaw","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":47},"100513144","phase-2-cladribine-vs-placebo-for-non-active-progressive-multiple-sclerosis-clasp-ms-100513144","NCT05961644","Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS).","Safety and Efficacy of Subcutaneous Cladribine for Nonrelapsing, Secondary Progressive Multiple Sclerosis (CLASP-MS): a Randomized, Placebo-controlled, Double-blind, Phase 2 Study.","CLASP-MS","Inclusion Criteria:\n\n* Written informed consent\n* Diagnosis of relapse-onset, secondary progressive multiple sclerosis based on the 2017 McDonald criteria\n* Progression of disability over 24 months defined as an increase in the EDSS score of 1 or more for patients with EDSS ≤ 5.5 or of 0.5 or more for patients with EDSS \\> 5.5\n* Lack of relapses over last 12 months\n* EDSS of 3.5 - 7.5 inclusive\n* Age of 30 - 65 years inclusive\n* Duration of MS of 10 years or longer\n* Pre-menopausal women must refrain from heterosexual intercourse or use a contraception method with a failure rate of \\\u003C 1% from enrolment up to 6 months after the last dose of the investigational medicinal product\n* Men must refrain from heterosexual intercourse from enrolment up to 6 months after the last dose of the investigational medicinal product or use a barrier method of contraception, with their female partners using a contraception method with a failure rate of \\\u003C1%\n* Able to fulfill all protocol requirements as judged by the investigator\n\nExclusion Criteria:\n\n* Lack of written informed consent\n* Previous cladribine treatment\n* Hypersensitivity to the investigational medicinal product\n* Eligible and willing to use interferon beta, siponimod, or mitoxantrone\n* Unable to undergo magnetic resonance imaging\n* Pregnancy or breastfeeding\n* Does not agree to use contraception methods defined above\n* Diseases of the nervous system, such as tumors, stroke, traumatic injury, encephalomyelitis, B12 deficiency, or demyelinating diseases other than multiple sclerosis\n* Major comorbidities, such as cancer, liver failure, kidney failure, heart failure (NYHA II-III), or any other disease that may jeopardize patient safety or make it impossible for the patient to fulfill protocol requirements\n* Relapse within last 12 months\n* Chronic treatment with corticosteroids or immunosuppressants (eg, azathioprine, methotrexate, cyclosporine) within last 6 months\n* Disease-modifying treatments for multiple sclerosis (no washout is required for interferons beta, glatiramer acetate, and dimethyl fumarate; washout of \\> 6 months for teriflunomide, fingolimod, and natalizumab \\[an accelerate elimination procedure may be used for teriflunomide instead\\]; washout of \\> 12 months for ocrelizumab, mitoxantrone, and alemtuzumab)\n* Relapsing-remitting multiple sclerosis\n* Primary progressive multiple sclerosis\n* Hepatitis B or hepatitis C, including detectable HbsA, anti-HBc, or anti-HCV antibodies in serum\n* HIV infection, including a positive screening test (anti-HIV 1\u002F2, protein 24)\n* Active or latent tuberculosis, including a positive result of the QuantiFERON TB Gold test during screening or within 3 months (an inconclusive test must be repeated; two inconclusive tests are taken as a positive result)\n* Other infection that may be worsened by treatment with cladribine\n* Lymphopenia (\\\u003C 1000\u002Fμl), neutrocytopenia (\\\u003C 1500\u002Fμl), or thrombocytopenia\n* Alanine aminotransferase or aspartate aminotransferase \\> 2 x ULN (can be repeated when 1.5-3x ULN); Total bilirubin \\> 1.5 x ULN (can be repeated when 1.5-3 x ULN); Hemoglobin \\> 9.5 g\u002FdL (can be repeated when 9-9.4 g\u002FdL)\n* Lack of vaccination against COVID-19 - the time from the last dose of a full vaccination regimen is shorter than 6 weeks\n* Any vaccination within last 6 weeks\n* Lack of cancer screening or suspicion of cancer or necessity to carry out additional studies after the following examinations done at screening: chest X-ray in all participants; mammography or breast ultrasound in women; cervical smear in women; prostate-specific antigen in men\n* Patient does not have detectable antibodies against Varicella zoster virus in serum or a proof of two-dose vaccination against this virus (last dose at least 6 months before enrolment)\n* Use of oral or parenteral anticoagulants or antiplatelets other than acetylsalicylic acid","30 Years","65 Years",{"count":59,"type":20},188,[61,62],"PHASE2","PHASE3","The purpose of the study is to evaluate the efficacy and safety of subcutaneously administered cladribine versus placebo to stop inflammation and treat disease progression of non-active secondary progressive multiple sclerosis.\n\nMultiple sclerosis is an inflammatory disease of the central nervous system. In most patients, it starts with a relapsing course (RMS) which is caused by acute inflammatory lesions in the brain and spinal cord. RMS transforms at later stages into progressive disease (secondary progressive MS). Currently approved disease-modifying treatments are effective in reducing clinical relapses and brain and spinal lesions visible in MR, but they perform poorly in preventing disease progression and overall disability accumulation. The growing evidence shows that disease progression partially depends on chronic inflammation present in the CNS. Drugs, which may cross the blood-brain barrier and reach inflammatory cells residing in the CNS might be effective in this stage of the disease. Cladribine is one of the DMT approved for RMS. It is a synthetic purine analog with selective lymphocyte toxicity, which enter the CNS and is found in cerebrospinal fluid. In patients treated with cladribine, the oligoclonal bands tend to disappear proving that neuroinflammation is diminished.\n\nThe participants of this clinical trial with the later non-active stage of MS are enrolled to be treated with cladribine subcutaneously or a non-active comparator (placebo) for 6 months and followed for the next 2 years, with an MRI scan and clinical evaluation every 6 months. The main questions it aims to answer are if in the non-active stage of MS cladribine is potent to lessen brain volume loss and if it is potent to attenuate inflammation in the CNS.",[65,66],"Multiple Sclerosis, Secondary Progressive","Multiple Sclerosis",[68,69,70,71,72,73],"Cladribine","Multiple Sclerosis Secondary Progressive","Brain Volume","Quantitative Susceptibility Mapping","Magnetic Resonance Imaging","Cognitive assessment","2023-07-26",{"date":76,"type":39},"2023-07-28",{"date":78,"type":39},"2022-10-03",{"date":80,"type":20},"2027-10-30",{"name":45,"class":46},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100491100","4fm-acceptance-training-as-the-new-form-of-cptsd-focused-treatment-based-on-existential-analysis-100491100","NCT05674734","4FM Acceptance Training as the New Form of cPTSD-focused Treatment Based on Existential Analysis","Relational Trauma as an Etiological Factor of Neurotic and\u002For Personality Disorders Training Acceptance 4FM as a New Form of Therapy for These Disorders","A4FM\u002FAE","Inclusion Criteria:\n\n1. Signed informed consent provide.\n2. Stable mental state allowing for reliable completion of the questionnaires.\n3. Native Polish language.\n4. Meeting the cPTSD diagnosis based on ITQ - International Trauma Questionnaire), self-report questionnaire, Cloitre et al. (2021), Polish version validated within the project.\n\nExclusion Criteria:\n\n1. No consent to participate in the research.\n2. Coexisting addiction to alcohol or psychoactive substances, documented intellectual disability, dementia or organic changes of the central nervous system.","60 Years",{"count":92,"type":20},100,[23],"Research project entitled \"The experience of relational trauma as an important etiological factor of neurotic and\u002For personality disorders. The 4FM Acceptance training as a new form of therapy for these disorders\" assumes the following goals:\n\n1. validation of the Polish version of the International Trauma Questionnaire (ITQ);\n2. assessment of prevalence of relational trauma among adult psychiatric patients hospitalized at the Institute of Psychiatry and Neurology;\n3. development a new therapeutic intervention - 4FM Acceptance training - based on the methodology of the Existential Analysis;\n4. assessment of the impact of the 4FM Acceptance training among patients with cPTSD.\n\nThe original therapeutic intervention - 4FM Acceptance training - will be developed based on the methodological assumptions of the 4 Fundamental Motivations (4FM) in the Existential Analysis methodology, developed by Alfried Längle, student of Viktor Frankl, a representative of the Existential Psychology, together with other important representatives, i.e. Rollo May, Irvin Yalom and in Poland prof. Antoni Kępiński.",[96],"Trauma",[98,99,100,101],"cPTSD","complex trauma treatment","4 Fundamental Motivations","Existential Analysis","NOT_YET_RECRUITING","2023-03-03",{"date":105,"type":39},"2023-03-06",{"date":107,"type":20},"2023-04-01",{"date":109,"type":20},"2026-12-31",{"name":45,"class":46},""]