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NCT Number: NCT07166536

Symptom Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms

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. 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. 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. Comparing patients who experience symptom exacerbation following mental imagery to those who do not. 4. Describing associations between symptom exacerbation and negative affectivity, anxiety, depression, catastrophizing, and lower daily functioning.

Methods: A cross-sectional study will be conducted on adult patients experiencing PPCS following mTBI. Participants will be recruited through convenience sampling from a computerized hospital database of Reuth Rehabilitation Hospital, based on inclusion and exclusion criteria.

After signing an informed consent form, participants will be invited to attend 2 to 3 sessions, each lasting 1 to 2 hours. During these sessions, a licensed physiotherapist will conduct a comprehensive clinical assessment, including: Completion of self-report questionnaires; A vestibular examination; Anamnestic interview and clinical assessment of individual movement- and scenario-related triggers for dizziness and headaches; Symptom provocation testing using mental imagery of the identified triggers.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Study Procedure

Phase 1 - Recruitment A sample will be drawn from the hospital's computerized database based on the inclusion and exclusion criteria.

Phase 2 - Patient Enrollment Potential patients will be contacted by phone and given an extensive overview of the study. They will be invited to participate in the study, and will have to arive to Reuth Rehabilitation Hospital in Tel Aviv in order to sign an informed cosent form in front of a physician that will give them an additional explanation about the study and will answer all their questions and conserns. Current patients of Reut Rehabilitation Hospital will be invited to attend research sessions during their regular treatment days. Patients who have been discharged from the hospital will be invited to participate in research sessions at their convenience, with the option to schedule the first session shortly after signing the informed consent form.

Phase 3 - Medical Record Data Collection Data extraction from patients' medical records, including demographic information, injury date and mechanism, physical and cognitive consequences, additional symptoms, imaging findings, medical history, medication use, previous treatments, and social, psychological, or psychiatric status.

Phase 4 - Clinical Assessments Assessment Session 1

  • Cognitive screening test: In accordance with the Institutional Review Board (IRB) requirement, the Mini-Mental State Examination (MMSE) will be administered to provide a gross screening of cognitive status and to confirm eligibility for informed consent and study participation. Participants scoring <20 points will be excluded.
  • Completion of self-reported questionnaires, including demographic information, symptoms and triggers, concussion symptomatology, dizziness-related disability, headache impact, catastrophizing, PTSD levels, anxiety, depression, negative affectivity and somatization.
  • Vestibular and oculomotor assessment, including the Video Head-Impulse Test (vHIT) to rule out central and peripheral vestibular pathology, conducted by a certified vestibular physiotherapist.

Assessment Session 2

  • Completion of the vestibular assessment and questionnaires (if not completed in Session 1).
  • Symptom provocation test using mental imagery in a randomized order:
  • Movement mental imagery: Randomized sequence of 2 provocative movements and 2 neutral movements for each symptom (headache and/or dizziness).
  • Scenario mental imagery: Randomized sequence of 2 provocative scenarios and 2 neutral scenarios for each symptom (headache and/or dizziness).

Assessment Session 3

  • Completion of pending assessments.

Phase 5 - Study Completion

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Exclusion of other potential causes of headaches, such as non-healed fractures, chronic inflammation/infection, increased intracranial pressure, or meningeal injury.
  • Headache intensity of at least 3/10 on the VAS scale.

Exclusion criteria

  • 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.

Treatment and study plan

Provocation Test for Symptoms Using Mental Imagery

Other
  • 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..."

Primary outcomes

  1. Headache intensity Change

    Time frame: Immediately before and after the intervention at assessment session 2

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

  2. Dizziness intensity change

    Time frame: Immediately before and after the intervention at assessment session 2

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

Secondary outcomes

  1. Headache Impact on Daily life

    Time frame: Within 1-2 weeks before the intervention

    Headache Impact Test-6 (HIT-6): A brief assessment tool used to measure the impact of headaches on daily life. The questionnaire includes six questions addressing the frequency of functional impairment, pain intensity, and quality of life related to headaches

  2. Post-Concussion Symptoms

    Time frame: Within 1-2 weeks before the intervention

    Rivermead Post-Concussion Symptoms Questionnaire (RPQ): A questionnaire assessing the severity of post-concussion symptoms. It includes 16 items where participants rate their symptoms compared to their pre-injury state on a Likert scale from 0 ("not experienced at all") to 4 ("severe problem").

  3. Perceived disability due to dizziness

    Time frame: Within 1-2 weeks before the intervention

    Dizziness Handicap Inventory (DHI): A questionnaire assessing the level of disability caused by dizziness. It consists of 25 items and provides a score in percentages, where 100% indicates a high level of perceived self-disability.

  4. Pain Catastrophizing

    Time frame: Within 1-2 weeks before the intervention

    Pain Catastrophizing Scale - A questionnaire assessing catastrophic thoughts related to pain, consisting of 13 items rated on a scale from 0 ("Never") to 4 ("Very much"). A high score indicates a tendency toward catastrophizing-exaggerated negative thoughts, helplessness, and magnification in response to pain.

  5. Anxiety

    Time frame: Within 1-2 weeks before the intervention

    Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire assessing anxiety (HADS-A) and depression (HADS-D) in medical patients. Each subscale consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21, where higher scores indicate greater symptom severity.

  6. Depression

    Time frame: Within 1-2 weeks before the intervention

    Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire assessing anxiety (HADS-A) and depression (HADS-D) in medical patients. Each subscale consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21, where higher scores indicate greater symptom severity.

  7. Positive and Negative Affect

    Time frame: Within 1-2 weeks before the intervention

    Positive and Negative Affect Schedule (PANAS): A questionnaire assessing positive and negative emotions, consisting of 20 items divided into two subscales: positive affect and negative affect. Participants rate the intensity of emotions they experienced over a specified period on a Likert scale from 1 ("Not at all") to 5 ("Very much").

  8. PTSD symptom levels

    Time frame: Within 1-2 weeks before the intervention

    Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5): A questionnaire assessing PTSD symptoms, including 20 items where participants rate symptom severity on a Likert scale from 0 ("Not at all") to 4 ("Very much").

  9. Somatization

    Time frame: Within 1-2 weeks before the intervention

    Somatization subscale of the Symptom Checklist-90-Revised (SCL-90-R): A questionnaire that assesses the presence and severity of somatic symptoms. It includes 12 items related to physical complaints such as pain, gastrointestinal issues, and cardiopulmonary symptoms. Each item is rated on a 0-4 Likert scale, with higher scores indicating greater levels of somatization.

Study contacts

Contact information is provided by the study sponsor or research team.

Gali Pinsky, BPT

CONTACT

[email protected]

972546326566

Yotam Yanai, BPT

CONTACT

[email protected]

972523993918

Sponsors and collaborators

Lead sponsor

Reuth Rehabilitation Hospital

Other

Registry information

Official study title

Characterization of Headache and Dizziness Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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