Role of the Radiologist in Management of Pulsatile Tinnitus

Sponsor
Mohab Mohammed (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05338684
Collaborator
(none)
50
1
19.5

Study Details

Study Description

Brief Summary

The aim of this study is to detect the role of interventional radiology in management of Pulsatile tinnitus and to detect the best imaging modality for Diagnosis.

Condition or Disease Intervention/Treatment Phase
  • Device: Colour doppler,MSCT,MRI
N/A

Detailed Description

Tinnitus is a broad and complex subject concerning a symptom rather than a syndrome or a disease (1 ),New studies indicate that prevalence of tinnitus is 14.5% among those less than 40 years old and 17.5 - 35% among age over 40 years Old( 2-3 ). Vascular tinnitus causes are multiple , Arterial causes like Atherosclerosis , Fibromuscular dysplasia or Dissection of the carotid or vertebral artery , Arteriovenous causes like Cerebral head and neck arteriovenous malformation , Dural arteriovenous fistula and Carotid cavernous fistula Venous like Systemic diseases with hyperdynamic circulation . Chronic anemia, pregnancy, thyrotoxicosis , Idiopathic intracranial hypertension and Dural venous sinus stenosis , Tumors also like Paraganglioma which Some authors believe that para-gangliomas are the most common cause of vascular tinnitus and Vascular metastasis And other Miscellaneous Causes like Paget's disease m Otosclerosis or Otomastoiditis , but others see dural arteriovenous fistula (AVF) ,idiopathicvenous tinnitus, or idiopathic intracranial hypertension the most common causes. (4 - 9) , Also One of the Most important Arterial causes is Atherosclerosis , Atherosclerotic plaques ma produce turbulence of carotid flow and occasionally cause pulsatile tinnitus (10 ) , FMD ( Fibromuscular Dysplasia ) seen in 0.5% to0.6% of carotid angiograms and autopsies, is the second most common cause of extracranial carotid narrowing (11) information obtained from both CT and MRI is complementary In some casesThe angiographic findings may include luminal stenosis, abrupt reconstitution of the lumen, dissecting aneurysm, intimal flap, slow flow, occlusion, and distal emboli (12-15)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
patients diagnosed with pulsatile tinnitus clinicallypatients diagnosed with pulsatile tinnitus clinically
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Role of the Radiologist in Management of Pulsatile Tinnitus
Anticipated Study Start Date :
Apr 17, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: diagnostic catheter intervention then therapeutic if indicated

Device: Colour doppler,MSCT,MRI
ultrasound/color duplex at Jugular veins & carotid and vertebral arteries first ,then MSCT/CTA mainly with relation of neck & Bain arteries to the bone of the skull in 6 mm cuts and/or MRI/MRA/MRV by standardized multi-parametric MR protocol will be implemented for all patients. All sequences will be acquired on a 1.5T MR scanner.

Outcome Measures

Primary Outcome Measures

  1. Manage pulsatile tinnitus with catheter angiography to all vascular lesion [Baseline]

    Manage pulsatile tinnitus causes with no indication for surgical intervention or prolonged and follow up and detect reported cases with pulsatile tinnitus could be managed by therapeutic angiography rather than other invasive surgical maneuver or Medical treatment

Secondary Outcome Measures

  1. To assess the accuracy of best imaging modality to diagnose pulsatile tinnitus . [Baseline]

    Detect accurate cause of pulsatile tinnitus and the best imaging for diagnosis with measurement of the percentage of indicated patient for therapeutic angiography rather than surgical intervention or follow up with medical treatment .

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with pulsatile tinnitus of unknown origin referred by a physician to diagnostic radiology to be assessed by imaging will be included in the study.

  • Patient's with clinical diagnosed pulsatile tinnitus.

  • patient refused surgical intervention.

Exclusion Criteria:
  • History of allergy to the contrast media , Contraindication to MRI and Refusal to sign a consent

  • Pregnant women

  • patients with atherosclerosis cause only or vascular loop more than 50% in internal auditory canal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mohab Mohammed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohab Mohammed, Role of the Radiologist in Management of Pulsatile tinnitus, Assiut University
ClinicalTrials.gov Identifier:
NCT05338684
Other Study ID Numbers:
  • Radiology role in tinnitus
First Posted:
Apr 21, 2022
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2022