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임상시험 NCT07256704 (HYPNOVA)은(는) 뇌졸중, 외상성 뇌 손상, 다발성 경화증에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis) (HYPNOVA)

모집중
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임상시험 NCT07256704 (HYPNOVA)은(는) 뇌졸중, 외상성 뇌 손상, 다발성 경화증에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 11월 18일에 시작되어 48명의 참여자를 모집하고 있습니다. Luzerner Kantonsspital이(가) 진행하며, 2029년 7월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 1일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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.

공식 제목

Hypnosis and Attention in Patients With a Neurological Disease

질환/상태
뇌졸중외상성 뇌 손상다발성 경화증
출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.
기타 연구 식별자
  • HYPNOVA
  • 2025-01374
NCT 번호
실제 연구 시작일
2025-11-18
최신 업데이트 게시
2025-12-01
예상 연구 완료일
2029-07-31
계획된 등록 인원
48
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Hypnosis
Attention deficit
Neurorehabilitation
Electroencephalography (EEG)
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Intervention
Hypnosis Intervention Participants receive hypnosis sessions designed to improve attention and reduce fatigue.
최면
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.
거짓 대조군Control
Sham Hypnosis Control Participants receive sham hypnosis sessions serving as a control condition.
최면
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.
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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.
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체

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
연구 대표 연락처
연락처: Thomas Nyffeler, Prof. Dr. med., +41412055686, [email protected]
1 1개국에 임상시험 장소
Luzerner Kantonsspital, Lucerne, Switzerland
Beatrice Ottiger, MSc OT, 연락처, +41412055535, [email protected]
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