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L'essai clinique NCT07256704 (HYPNOVA) pour Accident vasculaire cérébral, Lésion cérébrale traumatique, Sclérose en plaques est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis) (HYPNOVA)

En recrutement
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L'étude clinique NCT07256704 (HYPNOVA) est un essai interventionnel pour Accident vasculaire cérébral, Lésion cérébrale traumatique, Sclérose en plaques. Son statut actuel est : en recrutement. L'étude a débuté le 18 novembre 2025 et vise à recruter 48 participants. Dirigé par Luzerner Kantonsspital, l'essai devrait être terminé d'ici le 31 juillet 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 1 décembre 2025.
Résumé succinct
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.
Description détaillée
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.

Titre officiel

Hypnosis and Attention in Patients With a Neurological Disease

Conditions
Accident vasculaire cérébralLésion cérébrale traumatiqueSclérose en plaques
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • HYPNOVA
  • 2025-01374
Numéro NCT
Date de début (réel)
2025-11-18
Dernière mise à jour publiée
2025-12-01
Date de fin (estimée)
2029-07-31
Inscription (estimée)
48
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Hypnosis
Attention deficit
Neurorehabilitation
Electroencephalography (EEG)
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalIntervention
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.
Comparateur facticeControl
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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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.
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

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
Contact central de l'essai
Contact: Thomas Nyffeler, Prof. Dr. med., +41412055686, [email protected]
1 Centres de l'essai dans 1 pays
Luzerner Kantonsspital, Lucerne, Switzerland
Beatrice Ottiger, MSc OT, Contact, +41412055535, [email protected]
En recrutement