- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256704
Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis) (HYPNOVA)
Hypnosis and Attention in Patients With a Neurological Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Nyffeler, Prof. Dr. med.
- Phone Number: +41412055686
- Email: thomas.nyffeler@luks.ch
Study Locations
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Lucerne, Switzerland
- Recruiting
- Luzerner Kantonsspital
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Contact:
- Beatrice Ottiger, MSc OT
- Phone Number: +41412055535
- Email: beatrice.ottiger@luks.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: active: Intervention Hypnosis
Hypnosis Intervention Outpatient (Attention-Fatigue) Participants receive hypnosis sessions designed to improve attention and reduce fatigue. |
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.
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Sham Comparator: Placebo: Control Sham Hypnosis
Sham Hypnosis Control Participants receive sham hypnosis sessions serving as a control condition. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility of the study design and procedures
Time Frame: From enrollment to the end of treatment at 3 weeks
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The primary objective is to evaluate the feasiblity of conducting the study by assessing the completion rate.
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From enrollment to the end of treatment at 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Video-oculography during free visual exploration
Time Frame: Change before and after the intervention over the period of 3 weeks.
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The secondary endpoint is change in eye movement parameters during free visual exploration (FVE) from pre- to post-intervention, measured by video-oculography (mean gaze positions measured in °).
Furthermore, between-group differences (hypnosis vs sham-hypnosis) in FVE parameters post-intervention.
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Change before and after the intervention over the period of 3 weeks.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
- 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.
- 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.
- 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 the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- 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.
- 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.
- 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.
- 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.
- Bode LKG, Sprenger A, Helmchen C, Hauptmann B, Munte TF, Machner B. Combined optokinetic stimulation and cueing-assisted reading therapy to treat hemispatial neglect: A randomized controlled crossover trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101713. doi: 10.1016/j.rehab.2022.101713. Epub 2023 Jan 14.
- Rayegani SM, Heidari S, Seyed-Nezhad M, Kiyani N, Moradi-Joo M. Effectiveness of cognitive rehabilitation in comparison with routine rehabilitation methods in patients with multiple sclerosis: A systematic review and meta-analysis. Mult Scler J Exp Transl Clin. 2024 Sep 12;10(3):20552173241272561. doi: 10.1177/20552173241272561. eCollection 2024 Jul-Sep.
- Liu-Ambrose T, Falck RS, Dao E, Best JR, Davis JC, Bennett K, Hall PA, Hsiung GR, Middleton LE, Goldsmith CH, Graf P, Eng JJ. Effect of Exercise Training or Complex Mental and Social Activities on Cognitive Function in Adults With Chronic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236510. doi: 10.1001/jamanetworkopen.2022.36510.
- Alashram AR. Computerized cognitive rehabilitation for patients with traumatic brain injury: A systematic review of randomized controlled trials. Appl Neuropsychol Adult. 2026 Mar-Apr;33(2):578-587. doi: 10.1080/23279095.2024.2350607. Epub 2024 May 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Wounds and Injuries
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neurodevelopmental Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Attention Deficit and Disruptive Behavior Disorders
- Brain Injuries
- Brain Injuries, Traumatic
- Stroke
- Multiple Sclerosis
- Attention Deficit Disorder with Hyperactivity
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Psychotherapy
- Behavioral Disciplines and Activities
- Hypnosis
Other Study ID Numbers
- 2025-01374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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