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Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis) (HYPNOVA)

Offene Rekrutierung
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Die klinische Studie NCT07256704 (HYPNOVA) ist eine interventionsstudie zur Untersuchung von Schlaganfall, Traumatische Hirnverletzung, Multiple Sklerose und hat den Status offene rekrutierung. Die Studie startete am 18. November 2025 und soll 48 Teilnehmer aufnehmen. Durchgeführt von Luzerner Kantonsspital ist der Abschluss für 31. Juli 2029 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 1. Dezember 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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).

Current 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.

Hypnosis 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).

However, 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.

A 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.

Offizieller Titel

Hypnosis and Attention in Patients With a Neurological Disease

Erkrankungen
SchlaganfallTraumatische HirnverletzungMultiple Sklerose
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • HYPNOVA
  • 2025-01374
NCT-Nummer
Studienbeginn (tatsächlich)
2025-11-18
Zuletzt aktualisiert
2025-12-01
Studienende (vorauss.)
2029-07-31
Geplante Rekrutierung
48
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Hypnosis
Attention deficit
Neurorehabilitation
Electroencephalography (EEG)
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellIntervention
Hypnosis Intervention Participants receive hypnosis sessions designed to improve attention and reduce fatigue.
Hypnose
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.
Schein-VergleichspräparatControl
Sham Hypnosis Control Participants receive sham hypnosis sessions serving as a control condition.
Hypnose
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle

ICD-10 Diagnosis of stroke, TBI or MS Admitted to the inpatient and/or outpatient in the Clinic for Neurology and Neurorehabilitation Age 18 years old or older Understanding the German language Written informed consent

Psychiatric disease

Exclusion criteria for the EEG:

Scalp 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)

Luzerner Kantonsspital logoLuzerner Kantonsspital
Zentrale Studienkontakte
Kontakt: Thomas Nyffeler, Prof. Dr. med., +41412055686, [email protected]
1 Studienstandorte in 1 Ländern
Luzerner Kantonsspital, Lucerne, Switzerland
Beatrice Ottiger, MSc OT, Kontakt, +41412055535, [email protected]
Offene Rekrutierung