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临床试验 NCT07256704 (HYPNOVA) 针对中风,创伤性脑损伤,多发性硬化症目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis) (HYPNOVA)

招募中
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临床试验NCT07256704 (HYPNOVA)是一项针对中风,创伤性脑损伤,多发性硬化症干预性研究试验,目前试验状态为招募中。试验始于2025年11月18日,计划招募48名患者。该研究由Luzerner Kantonsspital主导,预计于2029年7月31日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年12月1日
简要概括
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.
详细描述
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.

官方标题

Hypnosis and Attention in Patients With a Neurological Disease

疾病
中风创伤性脑损伤多发性硬化症
出版物
关于此临床试验发表的科学文章和研究论文:
其他研究标识符
  • HYPNOVA
  • 2025-01374
NCT编号
实际开始日期
2025-11-18
最近更新发布
2025-12-01
预计完成日期
2029-07-31
计划入组人数
48
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Hypnosis
Attention deficit
Neurorehabilitation
Electroencephalography (EEG)
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性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.
模拟对照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.
主要终点
结果指标度量标准描述时间框架
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
次要终点
结果指标度量标准描述时间框架
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.
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部

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
研究中心联系人
联系人: Thomas Nyffeler, Prof. Dr. med., +41412055686, [email protected]
1 位于 1 个国家/地区的研究中心
Luzerner Kantonsspital, Lucerne, Switzerland
Beatrice Ottiger, MSc OT, 联系人, +41412055535, [email protected]
招募中