deltatrials
Recruiting INTERVENTIONAL NCT07166536

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

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

Sponsor: Reuth Rehabilitation Hospital

Updated 2 times since 2025 Last updated: Apr 9, 2026 Started: Sep 7, 2025 Primary completion: Dec 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Mild Traumatic Brain Injury, Concussion and Post Concussive Syndrome, Chronic, this trial is actively recruiting participants. The trial is conducted by Reuth Rehabilitation Hospital and has accumulated 2 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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...

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

Status Flow

~Oct 2025 – ~Apr 2026 · 6 months · monthly snapshotNot Yet RecruitingApr 16, 2026 – present · 3 months · daily APIRecruiting

Change History

2 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

    Status: Not Yet RecruitingRecruiting · Phase: NANone

  2. Oct 2025 — Apr 2026 [monthly]

    Not Yet Recruiting NA

    First recorded

Sep 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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. 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.

Contact Information

Sponsor contact:
  • Reuth Rehabilitation Hospital
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations