跳至主要内容
临床试验/NCT07256704
NCT07256704招募中不适用

Hypnosis and Attention in Patients With a Neurological Disease

Luzerner Kantonsspital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Feasibility of the study design and procedures

研究概览

简要总结

This feasibility study investigates the potential of hypnosis as a complementary therapy for improving attentional deficits and reducing fatigue in patients with neurological conditions 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 approaches. 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 feasibility, 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.

Current therapeutic approaches include cognitive rehabilitation, visual exploration training, and non-invasive brain stimulation to promote neuroplasticity and functional recovery. Additionally, management of fatigue focuses on energy regulation strategies in everyday life. 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. Preliminary evidence suggests hypnosis can improve attentional control and reduce fatigue in neurological populations.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

This study is a double-blind design, where both participants and outcome assessors are blinded to the intervention assignment. Participants will not know whether they are receiving hypnosis or sham hypnosis, minimizing expectancy and placebo effects. Outcome assessors who conduct attentional testing will also be blinded to group allocation to reduce assessment bias. Due to the nature of the intervention, the practitioner administering the sessions may be aware of the condition but will have no role in outcome assessment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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)

研究组 & 干预措施

active: Intervention Hypnosis

Experimental

Hypnosis Intervention Outpatient (Attention-Fatigue)

Participants receive hypnosis sessions designed to improve attention and reduce fatigue.

干预措施: Intervention Hypnosis (Other)

Placebo: Control Sham Hypnosis

Sham Comparator

Sham Hypnosis Control

Participants receive sham hypnosis sessions serving as a control condition.

干预措施: Intervention Hypnosis (Other)

结局指标

主要结局

Feasibility of the study design and procedures

时间窗: From enrollment to the end of treatment at 3 weeks

The primary objective is to evaluate the feasiblity of conducting the study by assessing the completion rate.

次要结局

  • Video-oculography during free visual exploration(Change before and after the intervention over the period of 3 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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