NCT07166536

Brief Summary

Background: Mild Traumatic Brain Injury (mTBI) often results in persistent emotional, cognitive, and somatic symptoms-such as headaches and dizziness. These symptoms impose a significant burden, yet their underlying mechanisms remain unclear. Predictive processing theories suggest that persistent symptoms may result from learned perceptual errors, particularly in individuals with high negative affectivity. This framework may help explain ongoing persistent post-concussive symptoms (PPCS) in the absence of identifiable pathology, which have been linked to various psychological factors. Mental imagery (MI) is thought to engage similar predictive processes. There is evidence that MI of symptom-triggering movements may exacerbate symptoms in individuals with chronic somatic conditions. However, this phenomenon has not been studied in PPCS patients. Investigating symptom provocation through MI may yield novel insights into the neuropsychological mechanisms sustaining PPCS and potentially contribute to the development of therapeutic tools for this population. Objectives:

  1. 1.Documenting the exacerbation of headache and dizziness following provocative mental imagery (imagery of movements or scenarios that elicit these symptoms in real life) in patients with PPCS.
  2. 2.Comparing changes in headache and dizziness after provocative MI versus neutral MI (imagery of movements or scenarios that do not elicit these symptoms in real life).
  3. 3.Comparing patients who experience symptom exacerbation following mental imagery to those who do not.
  4. 4.Describing associations between symptom exacerbation and negative affectivity, anxiety, depression, catastrophizing, and lower daily functioning.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

September 3, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 14, 2026

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 3, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

mild traumatic brain injuryPersistent Post-Concussion Symptomsmental imageryconcussion

Outcome Measures

Primary Outcomes (2)

  • Headache intensity Change

    Measured on a 100mm Visual Analog Scale from 0 ("no Pain") to 100 ("most severe Pain")

    Immediately before and after the intervention at assessment session 2

  • Dizziness intensity change

    Measured on a 100mm Visual Analog Scale from 0 ("no dizziness") to 100 ("most severe dizziness")

    Immediately before and after the intervention at assessment session 2

Secondary Outcomes (9)

  • Headache Impact on Daily life

    Within 1-2 weeks before the intervention

  • Post-Concussion Symptoms

    Within 1-2 weeks before the intervention

  • Perceived disability due to dizziness

    Within 1-2 weeks before the intervention

  • Pain Catastrophizing

    Within 1-2 weeks before the intervention

  • Anxiety

    Within 1-2 weeks before the intervention

  • +4 more secondary outcomes

Study Arms (1)

Mental Imagery Provocation Testing

EXPERIMENTAL

Provocation Test for Symptoms Using Mental Imagery: 1. Baseline symptom intensity (dizziness/headache) will be measured using the VAS scale. 2. Instruction to perform the movement that is hypothesized to provoke the symptom in reality for approximately 10-20 seconds 3. Measurement of symptom intensity using the VAS scale following the provoked movement. 4. Rest period of several minutes. 5. Measurement of symptom intensity following rest using the VAS scale. 6. Instruction to mentally imagine the movement or scenario hypothesized to provoke the symptom in reality for approximately 10-20 seconds 7. Measurement of symptom intensity using the VAS scale following mental imagery. 8. Measurement of imagery vividness using the VAS-V scale.

Other: Provocation Test for Symptoms Using Mental Imagery

Interventions

• The mental imagery task will be guided by the examiner through continuous verbal instruction (the examiner will provide ongoing instructions throughout the entire task, not just at the beginning). During the instruction, the examiner will direct the participant's attention to visual, auditory, and proprioceptive aspects of the imagined movement or scenario. Example: "Close your eyes, and without moving your head or body at all, try to imagine that you are moving your head from side to side quickly and easily, while noticing the sensation of motion, seeing the rotation through your eyes, and feeling the acceleration of your head as it moves from side to side..."

Mental Imagery Provocation Testing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current patients of Reut Rehabilitation Hospital or individuals who were discharged from the hospital within the past 12 months.
  • Diagnosis of mild Traumatic Brain Injury, concussion, blast injury, or cervical whiplash injury.
  • More than 3 months since the event.
  • Presence of headaches and/or dizziness that began after the injury and have persisted continuously or intermittently.
  • Headache intensity of at least 3/10 on the VAS scale.

You may not qualify if:

  • Significant cognitive impairment preventing informed consent (Mini-Mental State Examination score \<20 or Montreal Cognitive Assessment score \<20, as per IRB requirements).
  • Diagnosed central neurological conditions such as multiple sclerosis, Parkinson's disease, stroke, or brain tumor.
  • Presence of known pyramidal or extrapyramidal neurological signs.
  • Significant language impairment interfering with communication.
  • Psychiatric disorders significantly affecting communication.
  • Use of vestibular-suppressant medication (e.g., Cinnarizine) with an inability or unwillingness to discontinue treatment 24 hours prior to testing.
  • Withdrawal Criteria:
  • \. Oculomotor dysfunction affecting multiple oculomotor functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

RECRUITING

Related Publications (5)

  • Polinder S, Cnossen MC, Real RGL, Covic A, Gorbunova A, Voormolen DC, Master CL, Haagsma JA, Diaz-Arrastia R, von Steinbuechel N. A Multidimensional Approach to Post-concussion Symptoms in Mild Traumatic Brain Injury. Front Neurol. 2018 Dec 19;9:1113. doi: 10.3389/fneur.2018.01113. eCollection 2018.

    PMID: 30619066BACKGROUND
  • de Neeling M, Liessens D, Depreitere B. Relationship between psychosocial and psychiatric risk factors and poor long-term outcome following mild traumatic brain injury: A systematic review. Eur J Neurol. 2023 May;30(5):1540-1550. doi: 10.1111/ene.15713. Epub 2023 Feb 15.

    PMID: 36708085BACKGROUND
  • Dijkstra N, Bosch SE, van Gerven MAJ. Shared Neural Mechanisms of Visual Perception and Imagery. Trends Cogn Sci. 2019 May;23(5):423-434. doi: 10.1016/j.tics.2019.02.004. Epub 2019 Mar 12.

    PMID: 30876729BACKGROUND
  • Van den Bergh O, Witthoft M, Petersen S, Brown RJ. Symptoms and the body: Taking the inferential leap. Neurosci Biobehav Rev. 2017 Mar;74(Pt A):185-203. doi: 10.1016/j.neubiorev.2017.01.015. Epub 2017 Jan 17.

    PMID: 28108416BACKGROUND
  • Moseley GL, Zalucki N, Birklein F, Marinus J, van Hilten JJ, Luomajoki H. Thinking about movement hurts: the effect of motor imagery on pain and swelling in people with chronic arm pain. Arthritis Rheum. 2008 May 15;59(5):623-31. doi: 10.1002/art.23580.

    PMID: 18438892BACKGROUND

MeSH Terms

Conditions

Brain ConcussionPost-Concussion SyndromePost-Traumatic Headache

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingHeadache Disorders, SecondaryHeadache Disorders

Study Officials

  • Keren Sivan-Speier, MD

    Reuth Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yotam Yanai, BPT

CONTACT

Gali Pinsky, BPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

September 7, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 14, 2026

Record last verified: 2025-09

Locations