Pulsatile Tinnitus (Diagnosis)NCT05338684
Role of the Radiologist in Management of Pulsatile Tinnitus
A study testing Colour doppler,MSCT,MRI in people with Pulsatile Tinnitus (Diagnosis), run by Mohab Mohammed.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulsatile Tinnitus (Diagnosis)
- What is being tested?
- Colour doppler,MSCT,MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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)
- Conditions
- Pulsatile Tinnitus (Diagnosis)
- Being tested
- Colour doppler,MSCT,MRI
- Medical subject headings
- Tinnitus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colour doppler,MSCT,MRIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| diagnostic catheter intervention then therapeutic if indicated | Experimental | Not described Receives: Device: Colour doppler,MSCT,MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manage pulsatile tinnitus with catheter angiography to all vascular lesion
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
Measured: Baseline
Secondary outcomes (1)
To assess the accuracy of best imaging modality to diagnose pulsatile tinnitus .
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 .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start17 Apr 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulsatile Tinnitus (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients diagnosed with pulsatile tinnitus clinically
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohab Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohab Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338684
- Sponsor's protocol ID
- Radiology role in tinnitus
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003 Feb;58(2):28-34.
PubMed 12596495Heller AJ. Classification and epidemiology of tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):239-48. doi: 10.1016/s0030-6665(02)00160-3.
PubMed 12856294Mehanna R, Shaltoni H, Morsi H, Mawad M. Endovascular treatment of sigmoid sinus aneurysm presenting as devastating pulsatile tinnitus. A case report and review of literature. Interv Neuroradiol. 2010 Dec;16(4):451-4. doi: 10.1177/159101991001600413. Epub 2010 Dec 17.
PubMed 21162777Schleuning A. Neurotologic evaluation of subjective idiopathic tinnitus. J Laryngol Otol Suppl. 1981;(4):99-101. No abstract available.
PubMed 6946175Dietz RR, Davis WL, Harnsberger HR, Jacobs JM, Blatter DD. MR imaging and MR angiography in the evaluation of pulsatile tinnitus. AJNR Am J Neuroradiol. 1994 May;15(5):879-89.
PubMed 8059655George B, Reizine D, Laurian C, Riche MC, Merland JJ. Tinnitus of venous origin. Surgical treatment by the ligation of the jugular vein and lateral sinus jugular vein anastomosis. J Neuroradiol. 1983;10(1):23-30. No abstract available. English, French.
PubMed 6864262Sismanis A. Pulsatile tinnitus. A 15-year experience. Am J Otol. 1998 Jul;19(4):472-7.
PubMed 9661757Sismanis A. Pulsatile tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):389-402, viii. doi: 10.1016/s0030-6665(02)00169-x.
PubMed 12856306Waldvogel D, Mattle HP, Sturzenegger M, Schroth G. Pulsatile tinnitus--a review of 84 patients. J Neurol. 1998 Mar;245(3):137-42. doi: 10.1007/s004150050193.
PubMed 9553842Sandok BA, Whisnant JP, Furlan AJ, Mickell JL. Carotid artery bruits: prevalence survey and differential diagnosis. Mayo Clin Proc. 1982 Apr;57(4):227-30.
PubMed 7070118Corrin LS, Sandok BA, Houser OW. Cerebral ischemic events in patients with carotid artery fibromuscular dysplasia. Arch Neurol. 1981 Oct;38(10):616-8. doi: 10.1001/archneur.1981.00510100044005.
PubMed 7295104Gelbert F, Assouline E, Hodes JE, Reizine D, Woimant F, George B, Hagueneau M, Merland JJ. MRI in spontaneous dissection of vertebral and carotid arteries. 15 cases studied at 0.5 tesla. Neuroradiology. 1991;33(2):111-3. doi: 10.1007/BF00588245.
PubMed 2046892
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Radiologist in Management of Pulsatile Tinnitus
- ClinicalTrials.gov ID
- NCT05338684
- Acronym / sponsor ID
- Radiology role in tinnitus
- Conditions
- Pulsatile Tinnitus (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mohab MohammedUniversity, hospital or other
- Study start
- 17 Apr 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients diagnosed with pulsatile tinnitus clinically
| Arm | Type | Receives |
|---|---|---|
| diagnostic catheter intervention then therapeutic if indicated | Experimental | Device: Colour doppler,MSCT,MRI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colour doppler,MSCT,MRIultrasound/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. | Device | diagnostic catheter intervention then therapeutic if indicated |
Primary outcome
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
1 secondary outcome
To assess the accuracy of best imaging modality to diagnose pulsatile tinnitus .
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Background: PubMed 12596495Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003 Feb;58(2):28-34.
- Background: PubMed 12856294Heller AJ. Classification and epidemiology of tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):239-48. doi: 10.1016/s0030-6665(02)00160-3.
- Background: PubMed 21162777Mehanna R, Shaltoni H, Morsi H, Mawad M. Endovascular treatment of sigmoid sinus aneurysm presenting as devastating pulsatile tinnitus. A case report and review of literature. Interv Neuroradiol. 2010 Dec;16(4):451-4. doi: 10.1177/159101991001600413. Epub 2010 Dec 17.
- Background: PubMed 6946175Schleuning A. Neurotologic evaluation of subjective idiopathic tinnitus. J Laryngol Otol Suppl. 1981;(4):99-101. No abstract available.
- Background: PubMed 8059655Dietz RR, Davis WL, Harnsberger HR, Jacobs JM, Blatter DD. MR imaging and MR angiography in the evaluation of pulsatile tinnitus. AJNR Am J Neuroradiol. 1994 May;15(5):879-89.
- Background: PubMed 6864262George B, Reizine D, Laurian C, Riche MC, Merland JJ. Tinnitus of venous origin. Surgical treatment by the ligation of the jugular vein and lateral sinus jugular vein anastomosis. J Neuroradiol. 1983;10(1):23-30. No abstract available. English, French.
- Background: PubMed 9661757Sismanis A. Pulsatile tinnitus. A 15-year experience. Am J Otol. 1998 Jul;19(4):472-7.
- Background: PubMed 12856306Sismanis A. Pulsatile tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):389-402, viii. doi: 10.1016/s0030-6665(02)00169-x.
- Background: PubMed 9553842Waldvogel D, Mattle HP, Sturzenegger M, Schroth G. Pulsatile tinnitus--a review of 84 patients. J Neurol. 1998 Mar;245(3):137-42. doi: 10.1007/s004150050193.
- Background: PubMed 7070118Sandok BA, Whisnant JP, Furlan AJ, Mickell JL. Carotid artery bruits: prevalence survey and differential diagnosis. Mayo Clin Proc. 1982 Apr;57(4):227-30.
- Background: PubMed 7295104Corrin LS, Sandok BA, Houser OW. Cerebral ischemic events in patients with carotid artery fibromuscular dysplasia. Arch Neurol. 1981 Oct;38(10):616-8. doi: 10.1001/archneur.1981.00510100044005.
- Background: PubMed 2046892Gelbert F, Assouline E, Hodes JE, Reizine D, Woimant F, George B, Hagueneau M, Merland JJ. MRI in spontaneous dissection of vertebral and carotid arteries. 15 cases studied at 0.5 tesla. Neuroradiology. 1991;33(2):111-3. doi: 10.1007/BF00588245.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Colour doppler,MSCT,MRI in people with Pulsatile Tinnitus (Diagnosis), run by Mohab Mohammed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohab Mohammed, Dem (01555151888, mohabmohammed812@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manage pulsatile tinnitus with catheter angiography to all vascular lesion (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05338684, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.