[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612678":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":30,"studyPopulation":18,"armGroups":31,"interventions":43,"overallOfficials":18,"centralContacts":48,"locations":54,"responsibleParty":71,"collaborators":18,"id":73,"slug":18,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":18,"enrollmentInfo":82,"targetDuration":18,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Luzerner Kantonsspital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of the study design and procedures","The primary objective is to evaluate the feasiblity of conducting the study by assessing the recruitment process, including eligibility and consent rates, determining the participant retention rate troughout the intervention period; conducting baseline assessments, identifying reasons for participants drop-out or non-completion, exploring participant adherence to the intervention protocol and follow-up procedures.","From enrollment to the end of treatment at 3 weeks",[14],{"measure":15,"description":16,"timeFrame":17},"Video-oculography during free visual exploration","The secondary endpoints are changes in eye movement parameters during free visual exploration (FVE) from pre- to post-intervention, measured by video-oculography (e.g., fixation duration, saccade amplitude, mean gaze positions). Furthermore, between-group differences (hypnosis vs sham-hypnosis) in FVE parameters post-intervention.","Change before and after the intervention over the period of 3 weeks.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Participants are randomly assigned to one of two groups: the hypnosis intervention group or the sham hypnosis control group.\n\nArm 1: Hypnosis Intervention\n\nDescription: Participants receive hypnosis sessions designed to improve attention and reduce fatigue.\n\nArm 2: Sham Hypnosis Control\n\nDescription: Participants receive sham hypnosis sessions serving as a control condition.","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"DOUBLE","This study is a double-blind design, where both participants and outcome assessors are blinded to the intervention assignment. Participants will not know whether they are receiving hypnosis or sham hypnosis, minimizing expectancy and placebo effects. Outcome assessors who conduct attentional testing will also be blinded to group allocation to reduce assessment bias. Due to the nature of the intervention, the practitioner administering the sessions may be aware of the condition but will have no role in outcome assessment.",[28,29],"PARTICIPANT","OUTCOMES_ASSESSOR","Neurological conditions such as stroke, traumatic brain injury (TBI), and multiple sclerosis (MS) frequently cause significant impairments in attentional abilities. Commonly accompanying symptoms include visual spatial neglect (VSN) and fatigue syndrome, which exacerbate attentional deficits. These impairments manifest notably as a reduction in spontaneous or free visual exploration (FVE), limiting patients' ability to actively scan and engage with their environment. This diminished visual exploration negatively impacts their capacity to navigate daily surroundings, compromising functional independence and overall quality of life (Chiaravalloti \\& DeLuca, 2008; Dillon et al., 2022; Huang et al., 2022).\n\nCurrent therapeutic approaches include cognitive rehabilitation, visual exploration training, and non-invasive brain stimulation to promote neuroplasticity and functional recovery (Alashram AR, 2024; Liu-Ambrose et al., 2022; Rayegani et al., 2024; Bode et al., 2023; Lefaucheur et al., 2020). Additionally, management of fatigue focuses on energy regulation strategies in everyday life (Hersche et al., 2019). Despite these interventions, many patients continue to experience persistent attentional deficits and fatigue after rehabilitation, limiting their ability to perform daily activities and return to previous roles.\n\nHypnosis is emerging as a promising adjunct therapy in neurological rehabilitation. Widely used in medical fields such as pain management and mental health, hypnosis leverages the brain's ability to enter a state of focused attention and heightened cognitive receptivity, facilitating symptom relief and treatment enhancement without pharmacological side effects (Montgomery et al., 2002; Ogez et al., 2024; Rosendahl et al., 2023; Valentine et al., 2019). Preliminary evidence suggests hypnosis can improve attentional control and reduce fatigue in neurological populations (Gilbert et al., 2006; Jensen et al., 2025).\n\nHowever, research on hypnosis in neurology remains limited, with a need for larger, rigorously controlled studies to confirm its efficacy and understand underlying mechanisms. This feasibility study aims to assess the practicality and acceptability of using hypnosis to treat attentional deficits and fatigue in patients with stroke, TBI, and MS, while also evaluating preliminary efficacy.\n\nA key aspect of this study involves recording electroencephalography (EEG) during both hypnosis and sham-hypnosis sessions. EEG data will provide insight into neural correlates of attentional processing and determine whether hypnosis induces measurable changes in brain activity relative to sham conditions.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Intervention","EXPERIMENTAL","Hypnosis Intervention\n\nParticipants receive hypnosis sessions designed to improve attention and reduce fatigue.",[37],"Other: Hypnosis",{"label":39,"type":40,"description":41,"interventionNames":42},"Control","SHAM_COMPARATOR","Sham Hypnosis Control\n\nParticipants receive sham hypnosis sessions serving as a control condition.",[37],[44],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"Hypnosis","Hypnosis sessions designed to improve attentional control and reduce fatigue in patients with neurological conditions (stroke, TBI, MS). The intervention involves guided hypnotic induction and suggestions tailored to enhance cognitive focus and energy management.",[39,33],[49],{"name":50,"role":51,"phone":52,"phoneExt":18,"email":53},"Thomas Nyffeler, Prof. Dr. med.","CONTACT","+41412055686","thomas.nyffeler@luks.ch",[55],{"facility":5,"status":56,"city":57,"state":18,"zip":18,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Lucerne","Switzerland","CH",{"type":61,"coordinates":62},"Point",[63,64],8.30635,47.05048,{"lat":64,"lon":63},[67],{"name":68,"role":51,"phone":69,"phoneExt":18,"email":70},"Beatrice Ottiger, MSc OT","+41412055535","beatrice.ottiger@luks.ch",{"type":72,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100612678",false,"NCT07256704","Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis)","Hypnosis and Attention in Patients With a Neurological Disease","HYPNOVA","Inclusion Criteria:\n\nICD-10 Diagnosis of stroke, TBI or MS Admitted to the inpatient and\u002For outpatient in the Clinic for Neurology and Neurorehabilitation Age 18 years old or older Understanding the German language Written informed consent\n\nExclusion Criteria:\n\nPsychiatric disease\n\nExclusion criteria for the EEG:\n\nScalp or skin conditions that interfere with EEG electrode placement (e.g. open wounds, infections, severe psoriasis) Implanted medical or neurostimulation devices that interfere with EEG electrode placement (e.g. deep brain stimulators, cochlear implants)","ALL","18 Years",{"count":83,"type":84},48,"ESTIMATED","INTERVENTIONAL",[87],"NA","This feasibility study investigates the potential of hypnosis as a complementary therapy to improve attentional deficits and fatigue in patients with neurological diseases such as stroke, traumatic brain injury (TBI), and multiple sclerosis (MS). These patients often experience reduced spontaneous visual exploration and impaired functional independence despite current rehabilitation methods. By integrating hypnosis with standard care, and using EEG to monitor brain activity during hypnosis and sham-hypnosis sessions, this trial aims to evaluate the practicality, acceptability, and preliminary efficacy of hypnosis in enhancing attention and reducing fatigue.",[90,91,92],"Stroke","Traumatic Brain Injury","Multiple Sclerosis",[45,94,95,96],"Attention deficit","Neurorehabilitation","Electroencephalography (EEG)","2025-11-20",{"date":99,"type":100},"2025-12-01","ACTUAL",{"date":102,"type":100},"2025-11-18",{"date":104,"type":84},"2029-07-31",{"name":5,"class":6},1]