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

Reuth Rehabilitation Hospital

Status: Not yet enrolling

Conditions: Post Traumatic Headache; Mild Traumatic Brain Injury, Concussion; Post Concussive Syndrome, Chronic

Treatments: Other: Provocation Test for Symptoms Using Mental Imagery

Study type: Interventional

Funder types: Other

Identifiers

NCT07166536

0003-25-RRH

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Mental Imagery Provocation Testing

Experimental group

Description:

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.

Treatment:

Other: Provocation Test for Symptoms Using Mental Imagery