Role of the Radiologist in Management of Pulsatile Tinnitus

April 16, 2022 updated by: Mohab Mohammed
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manage pulsatile tinnitus with catheter angiography to all vascular lesion
Time Frame: 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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the accuracy of best imaging modality to diagnose pulsatile tinnitus .
Time Frame: 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 .
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohab Mohammed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 17, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 2, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 16, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Radiology role in tinnitus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulsatile Tinnitus (Diagnosis)

Clinical Trials on Colour doppler,MSCT,MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe