Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis)

NCT07256704 | Recruiting DMC

• 1 other identifier: 2025-01374
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Traumatic Brain Injury; Multiple Sclerosis

Keywords

Hypnosis; Attention deficit; Neurorehabilitation; Electroencephalography (EEG)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Video-oculography during free visual exploration

  Change before and after the intervention over the period of 3 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Hypnosis

Control

SHAM COMPARATOR

Sham Hypnosis Control Participants receive sham hypnosis sessions serving as a control condition.

Other: Hypnosis

Interventions

Hypnosis OTHER

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychiatric disease
• 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)

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

Related Publications (13)

• 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.

  PMID: 19234967 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31251710 BACKGROUND

• 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.

  PMID: 38268815 BACKGROUND

• 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.

  PMID: 38481624 BACKGROUND

• 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.

  PMID: 12032044 BACKGROUND

• 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.

  PMID: 31280074 BACKGROUND

• 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.

  PMID: 31901449 BACKGROUND

• 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.

  PMID: 36645965 BACKGROUND

• 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.

  PMID: 39290831 BACKGROUND

• 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.

  PMID: 36227593 BACKGROUND

• Alashram AR. Computerized cognitive rehabilitation for patients with traumatic brain injury: A systematic review of randomized controlled trials. Appl Neuropsychol Adult. 2024 May 10:1-10. doi: 10.1080/23279095.2024.2350607. Online ahead of print.

  PMID: 38726576 BACKGROUND

• 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.

  PMID: 19007738 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Multiple Sclerosis; Attention Deficit Disorder with Hyperactivity

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Thomas Nyffeler, Prof. Dr. med.

CONTACT

+41412055686; thomas.nyffeler@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two groups: the hypnosis intervention group or the sham hypnosis control group. Arm 1: Hypnosis Intervention Description: Participants receive hypnosis sessions designed to improve attention and reduce fatigue. Arm 2: Sham Hypnosis Control Description: Participants receive sham hypnosis sessions serving as a control condition.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CH (1)