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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-07

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Mild Traumatic Brain Injury, Concussion Post Concussive Syndrome, Chronic Post Traumatic Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mental Imagery Provocation Testing

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.

Group Type EXPERIMENTAL

Provocation Test for Symptoms Using Mental Imagery

Intervention Type 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..."

Interventions

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Provocation Test for Symptoms Using Mental Imagery

• 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..."

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Current patients of Reut Rehabilitation Hospital or individuals who were discharged from the hospital within the past 12 months.
2. Diagnosis of mild Traumatic Brain Injury, concussion, blast injury, or cervical whiplash injury.
3. More than 3 months since the event.
4. Presence of headaches and/or dizziness that began after the injury and have persisted continuously or intermittently.
5. Exclusion of other potential causes of headaches, such as non-healed fractures, chronic inflammation/infection, increased intracranial pressure, or meningeal injury.
6. Headache intensity of at least 3/10 on the VAS scale.

Exclusion Criteria

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

Withdrawal Criteria:

1\. Oculomotor dysfunction affecting multiple oculomotor functions.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No