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Идёт набор NCT07256704

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

Без фазы С лечением Stroke Traumatic Brain Injury Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hypnosis.
Кому может быть актуально
Состояния в реестре: Stroke, Traumatic Brain Injury, Multiple Sclerosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Hypnosis and Attention in Patients With a Neurological Disease

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Feasibility of the study design and procedures [Срок оценки: From enrollment to the end of treatment at 3 weeks]
Вторичные конечные точки (1)
  • Video-oculography during free visual exploration [Срок оценки: Change before and after the intervention over the period of 3 weeks.]

Критерии участия

Критерии включения

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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • Luzerner Kantonsspital — Lucerne

Публикации

  • Jensen MP, Barber J, Romano JM, Molton IR, Raichle KA, Osborne TL, Engel JM, Stoelb BL, Kraft GH, Patterson DR. A comparison of self-hypnosis versus progressive muscle relaxation in patients with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2009 Apr;57(2):198-221. doi: 10.1080/00207140802665476. PMID 19234967
  • Diamond, S. G., Davis, O. C., Schaechter, J. D., & Howe, R. D. (2006). Hypnosis for rehabilitation after stroke: six case studies. Contemporary hypnosis, 23(4), 173-180.
  • Valentine KE, Milling LS, Clark LJ, Moriarty CL. THE EFFICACY OF HYPNOSIS AS A TREATMENT FOR ANXIETY: A META-ANALYSIS. Int J Clin Exp Hypn. 2019 Jul-Sep;67(3):336-363. doi: 10.1080/00207144.2019.1613863. PMID 31251710
  • Rosendahl J, Alldredge CT, Haddenhorst A. Meta-analytic evidence on the efficacy of hypnosis for mental and somatic health issues: a 20-year perspective. Front Psychol. 2024 Jan 8;14:1330238. doi: 10.3389/fpsyg.2023.1330238. eCollection 2023. PMID 38268815
  • Ogez D, Landry M, Caron-Trahan R, Jusseaux AE, Aubin M, Veronneau J, Fournier V, Godin N, Idrissi M, Rainville P, Richebe P. Make me more comfortable: effects of a hypnosis session on pain perception in chronic pain patients. Front Psychol. 2024 Feb 28;15:1362208. doi: 10.3389/fpsyg.2024.1362208. eCollection 2024. PMID 38481624
  • Montgomery GH, David D, Winkel G, Silverstein JH, Bovbjerg DH. The effectiveness of adjunctive hypnosis with surgical patients: a meta-analysis. Anesth Analg. 2002 Jun;94(6):1639-45, table of contents. doi: 10.1097/00000539-200206000-00052. PMID 12032044
  • Hersche R, Weise A, Michel G, Kesselring J, Bella SD, Barbero M, Kool J. Three-week inpatient energy management education (IEME) for persons with multiple sclerosis-related fatigue: Feasibility of a randomized clinical trial. Mult Scler Relat Disord. 2019 Oct;35:26-33. doi: 10.1016/j.msard.2019.06.034. Epub 2019 Jun 29. PMID 31280074
  • Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on th PMID 31901449

Идентификаторы

NCT: NCT07256704 · 2025-01374

Первоисточники (государственные реестры)

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