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治験 NCT07256704 (HYPNOVA)(対象:脳卒中、外傷性脳損傷、多発性硬化症)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis) (HYPNOVA)

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07256704 (HYPNOVA) は 介入研究 臨床試験 で、脳卒中、外傷性脳損傷、多発性硬化症 に関するものです。現在は 募集中 で、2025年11月18日 から開始しています。48 名の参加者 の募集が計画されています。この治験は Luzerner Kantonsspital によって主催され、2029年7月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月1日 です。
概要
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.
詳細説明
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.

公式タイトル

Hypnosis and Attention in Patients With a Neurological Disease

疾患/病気
脳卒中外傷性脳損傷多発性硬化症
刊行物
この臨床試験について発表された科学記事と研究論文:
その他の研究識別子
  • HYPNOVA
  • 2025-01374
NCT番号
開始日
2025-11-18
最終更新日
2025-12-01
終了予定日
2029-07-31
目標参加者数
48
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Hypnosis
Attention deficit
Neurorehabilitation
Electroencephalography (EEG)
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群(アーム)/介入
参加グループ/群介入/治療法
実験的Intervention
Hypnosis Intervention Participants receive hypnosis sessions designed to improve attention and reduce fatigue.
催眠
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.
シャム対照薬Control
Sham Hypnosis Control Participants receive sham hypnosis sessions serving as a control condition.
催眠
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.
主要評価項目
評価指標指標の説明時間枠
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
副次評価項目
評価指標指標の説明時間枠
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.
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て

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
試験中央連絡先
連絡先: Thomas Nyffeler, Prof. Dr. med., +41412055686, [email protected]
1 1カ国の場所
Luzerner Kantonsspital, Lucerne, Switzerland
Beatrice Ottiger, MSc OT, 連絡先, +41412055535, [email protected]
募集中