Diagnostic Test of Choice for HELPS Syndrome
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|ClinicalTrials.gov Identifier: NCT03126955|
Recruitment Status : Unknown
Verified April 2017 by Christopher Honey, University of British Columbia.
Recruitment status was: Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment|
|HELPS Syndrome||Diagnostic Test: Pre-Operative CISS-MRI Sequences Diagnostic Test: Pre-Operative Interictal Laryngoscopy Diagnostic Test: Pre-Operative Unilateral and Contralateral Botox|
The treatment of HELPS syndrome begins with the correct diagnosis. Some patients are able to localize the side of their symptoms in HELPS syndrome while others are unable to. The purpose of this study is to prospectively study which of the following is the diagnostic test of choice for patients who are unable to localize their HELPS: 1. CISS MRI sequences, 2. interictal laryngoscopy, and 3. unilateral and contralateral Botox injections separated 3-months apart.
Both neuroradiologist and otolaryngologist will be blinded to the outcome of surgery and be asked "based on your diagnostic test, which side do you believe we should perform MVD surgery?"
|Study Type :||Observational|
|Estimated Enrollment :||6 participants|
|Official Title:||Microvascular Decompression for HELPS Syndrome: What is the Best Diagnostic Test?|
|Estimated Study Start Date :||April 30, 2017|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||October 30, 2018|
HELPS Syndrome unable to lateralize contractions
Each patient will have the following 3 diagnostic pre-operative tests: i) MRI (CISS sequence), ii) video laryngoscopy, and iii) sequential Botox injections in their throat (left side and then 3 months later on the right side).
Diagnostic Test: Pre-Operative CISS-MRI Sequences
Compare pre-operative MRI diagnosis to intra-operative findings on if both are in agreement
Diagnostic Test: Pre-Operative Interictal Laryngoscopy
Compare pre-operative laryngoscopy diagnosis to intra-operative findings on if both are in agreement
Diagnostic Test: Pre-Operative Unilateral and Contralateral Botox
Compare pre-operative diagnosis using Botox to intra-operative findings on if both are in agreement
Other Name: Injections spaced 3-months apart
- Pre-Operative CISS MRI (One month before surgery) compared to Intraoperative Findings [ Time Frame: Pre-Operative and Intra-Operative ]Determine if CISS MRI sequence lateralization in concordance with intraoperative findings
- Pre-Operative Interictal Laryngoscopy (One month before surgery) compared to Intraoperative Findings [ Time Frame: Pre-Operative vs. Intra-Operative ]Determine if interictal laryngoscopy in concordance with intraoperative findings
- Pre-Operative 3 and 6-month Botox Injections compared to Intraoperative Findings [ Time Frame: Pre-operative 3 and 6 months vs. Intra-Operative ]Determine if unilateral vs contralateral Botox-induced symptom reduction in concordance with intraoperative findings