Detecting Otoconia With CT-Scan

BPPV Clinical Trial

Official title:

Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05969340
• Other study ID #: NL 83124.068.22
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Academisch Ziekenhuis Maastricht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience short episodes of vertigo when there are changes in head position. The current theory on the causes of BPPV is the displacement of the otoconia from the otolith organ to the semicircular canal organs. BPPV's current treatments consist of repositioning maneuvers to readjust the location of the otoconia back to its original place. Even though the treatments are highly successful in many cases, this study, if proven successful, will help confirm this theory and will help diagnose complicated cases where BPPV is recurrent and treatment has been unsuccessful.

Description:

Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience vertigo when there are changes in head position. The prevalence is estimated to account for 20-30% of all vertigo diagnoses in a specialized clinic (von Brevern et al., 2007). The current theory on the cause of BPPV is the displacement of otoconia from the otolith organ to the semicircular canal organs due to gravitational forces.

Current treatments for BPPV consist of repositioning maneuvers to readjust the location of the otoconia back to its original place (von Brevern et al., 2015). Even though the treatment is highly successful in many cases patients still have recurrent (26%) or persistent (4%) symptoms (Dorigueto et al., 2009), and objective confirmation of the disease is warranted. Until now, visualization and confirmation of the presence of otoliths have not been successful in clinical practice. This is largely due to the very small size of the otoliths in a small inner ear structure, requiring sensitive and ultra-high-resolution imaging.

In 2021, a study was performed in Japan using 3 Dimensional Computed Tomography (3D CT) scans to detect the otoconia inside the horizontal canal. It compared scans of people with BPPV in the horizontal canal and healthy individuals (Yamane et al., 2021). The authors were able to visualize otoconia-like substance inside the canal in all 10 out of 10 affected patients and 6 out of 10 of the healthy participants in at least one ear (Yamane et al., 2021). In this study, the investigators will image the patients temporal bone with an ultra-high-resolution CT-scan (Benson et al.2022). They will focus on imaging the posterior canal for BPPV, and compare it with the imaging of individuals who do not have BPPV. In addition, they will compare the imaging of the canal pre and post-treatment using the Epley maneuver.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Experimental Group:

• Diagnosed with Posterior canal BPPV.

• Age 18 or older.

• Clear nystagmus consistent with canal direction and stimulation.

• Mild or greater complaints (none, mild, moderate, severe).

• Crescendo decrescendo nystagmus pattern.

• Slow phase eye velocity = 15 deg/sec.

Control Group:

• Scheduled for CI implantation CT scan.

• Age 18 or older.

Exclusion Criteria:

Experimental Group:

• Anterior or lateral canal BPPV.

• Inability to undergo CRM and DH maneuvers.

• Central vestibular disorders.

• Multi-canal BPPV or subjective BPPV.

• Pregnancy.

Control Group:

• BPPV, central vestibular disorders, multicanal BPPV, subjective BPPV.

• Ossifying labyrinthitis, DFNA9, obstructive vestibular schwannoma on MRI.

• Normal VHIT or history of meningitis.

• Pregnancy or other vestibular pathologies.

• Past history of BPPV.

Related Conditions & MeSH terms

• BPPV

Intervention

Diagnostic Test:
• ultra-high-resolution CT-scan
Use of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht

References & Publications (6)

Benson JC, Rajendran K, Lane JI, Diehn FE, Weber NM, Thorne JE, Larson NB, Fletcher JG, McCollough CH, Leng S. A New Frontier in Temporal Bone Imaging: Photon-Counting Detector CT Demonstrates Superior Visualization of Critical Anatomic Structures at Reduced Radiation Dose. AJNR Am J Neuroradiol. 2022 Apr;43(4):579-584. doi: 10.3174/ajnr.A7452. Epub 2022 Mar 24. — View Citation

Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol. 2009 Jul-Aug;75(4):565-72. doi: 10.1016/s1808-8694(15)30497-3. — View Citation

Rajendran K, Voss BA, Zhou W, Tao S, DeLone DR, Lane JI, Weaver JM, Carlson ML, Fletcher JG, McCollough CH, Leng S. Dose Reduction for Sinus and Temporal Bone Imaging Using Photon-Counting Detector CT With an Additional Tin Filter. Invest Radiol. 2020 Feb;55(2):91-100. doi: 10.1097/RLI.0000000000000614. — View Citation

von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553. — View Citation

von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29. — View Citation

Yamane H, Konishi K, Anniko M. Visualization of horizontal canal benign paroxysmal positional vertigo using 3DCT imaging and its assessment. Acta Otolaryngol. 2021 May;141(5):482-489. doi: 10.1080/00016489.2021.1892822. Epub 2021 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualisation of presence or absence of otoconia in the posterior semicircular canal by comparing patient with confirmed BPPV symptoms compared to control subjects without BPPV	The presence or absence of otoconia in the posterior semicircular canal will be assessed qualitatively and semi-quantitatively using the CT parameters for BPPV patients, and the radiological images will be compared to those of control subjects.	up to 1 hour
Secondary	Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.	Change in position of the otoconia will be assessed qualitatively and semi-quantitively using the CT parameters in BPPV patients by comparing the radiological images before and after repositioning maneuver (Epley)	up to 1 hour