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Diagnostic Test of Choice for HELPS Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Christopher Honey, University of British Columbia

Brief Summary:
Our team recently described a new medical condition called HELPS (Hemi-Laryngo-Pharyngeal-Spasm) syndrome(1). HELPS syndrome is a condition caused by a blood vessel pinching the nerve rootlets of the Vagus nerve (Xth cranial nerve). It is similar to the well recognized hemifacial spasm syndrome but the nerve involved is the Vagus instead of the Facial nerve. As a result, the symptoms are episodic throat contractions and cough. The throat contractions become stronger and more frequent over the years and can lead to a terrifying inability to breath. Patients may end up intubated in the Emergency Department or with a tracheostomy because of inability to breath during a severe episode. Some but not all of our patients can tell which side of their throat (left or right) contracts during a choking episode. In between these choking episodes, patients feel normal. A surgical cure for these patients is Microvascular Decompression of the Xth nerve.

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

Detailed Description:

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?"

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Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HELPS (Hemi-Laryngo-Pharyngeal Spasm) Syndrome

-Subgroup of patients who are unable to localize lateralization of throat contractions

Criteria

Inclusion Criteria:

  • Patients diagnosed with HELPS as described in our initial publication (Honey et al. 2016)
  • Patients unable to localize the side of their HELPS syndrome

Exclusion Criteria:

- Unable to provide informed consent


Publications:
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Responsible Party: Christopher Honey, Professor & Neurosurgeon, University of British Columbia
ClinicalTrials.gov Identifier: NCT03126955    
Other Study ID Numbers: H17-00953
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Honey, University of British Columbia:
microvascular decompression, Xth nerve
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents