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Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study

Primary Purpose

Hirayama Disease

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Posterior cervical fixation surgery
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hirayama Disease focused on measuring Hirayama disease, cervical collar, posterior cervical fixation surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All the following: Age ≥ 18 years Patients with Hirayama disease as per the following criteria (All of the following) (16): Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion) Progressive course, or initial progression followed by stationary course; and No evidence of a compressive lesion of the spinal cord. Disease duration of ≤4 years Progression of clinical symptoms in the past six-months Exclusion Criteria: Any of the following: Refusal to consent for randomization Not willing to come for three- and six-months follow-up

Sites / Locations

  • Deepti VibhaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical arm

Cervical collar arm

Arm Description

Will undergo posterior cervical fixation surgery within 4 weeks of randomization

Will be given cervical collar for regular use

Outcomes

Primary Outcome Measures

Odom's criteria score at six months

Secondary Outcome Measures

Odom's criteria score at three months
interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord
Electrophysiological and grip strength

Full Information

First Posted
July 18, 2023
Last Updated
September 12, 2023
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT05959980
Brief Title
Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study
Official Title
Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial] is to compare cervical collar versus neck stabilization surgery in diagnosed patients of Hirayama disease who have been reporting worsening of problems in the past six months. The main question[s] it aims to answer are: • Is cervical stabilization surgery (Posterior cervical fixation) superior to conservative management in the form of cervical collar placement in patients with progressive Hirayama disease, observed at six months after intervention Participants will have equal chance to: Undergo cervical fixation surgery Cervical collar management The investigators will study and compare the efficacy of both treatments upto six months after intervention
Detailed Description
Study design: Prospective randomized open blinded endpoint (PROBE), phase III study Inclusion criteria: All the following: Age ≥ 18 years Patients with Hirayama disease as per the following criteria (All of the following) (16): Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion) Progressive course, or initial progression followed by stationary course; and No evidence of a compressive lesion of the spinal cord. Disease duration of ≤4 years Progression of clinical symptoms in the past six-months c. Exclusion criteria: Any of the following: 1) Refusal to consent for randomization 2) Not willing to come for three- and six-months follow-up e. Procedures at baseline: Clinical, electrophysiology and autonomic function assessments: After the clinical diagnosis by inclusion criteria, the patients will undergo a detailed clinical examination (as per the case record form (CRF), which includes power, autonomic features, grip strength), and the objective assessment of the electrophysiological parameters Radiological assessment: All patients will undergo MR imaging on a 1.5 T MR scanner (Optima 450w, General Electric, Milwaukee, USA), using an 8-channel cervical-thoracic-lumbar array spine coil. The imaging will include axial and sagittal T2-WIs and post-gadolinium T1+C in flexion, neutral and extension positions. In addition, DTI protocol will include sagittal and axial acquisition of cervical cord in neutral position. MR-DTI data will process on a dedicated workstation (Advantage Windows workstation, GE Healthcare, WI, USA) using commercially available software (Functool 14.3.01, GE HealthCare, WI, USA). After co-registration of raw images to correct the motion and distortion artefacts, the ADC and FA images will be generated. The mean, minimum and maximum values of FA and ADC will be recorded from region of maximum cord compression/ T2-hyperintensity. The investogators will get a cervical spine radiograph at the time of discharge and at 6 months. Surgical procedure: The patients who are randomized to undergo posterior cervical fixation will be admitted in Neurosciences Centre, All India Institute of Medical Sciences, New Delhi. These patients will undergo routine preoperative work up, including routine blood investigations and a detailed preanesthetic checkup (PAC). These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirayama Disease
Keywords
Hirayama disease, cervical collar, posterior cervical fixation surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical arm
Arm Type
Experimental
Arm Description
Will undergo posterior cervical fixation surgery within 4 weeks of randomization
Arm Title
Cervical collar arm
Arm Type
No Intervention
Arm Description
Will be given cervical collar for regular use
Intervention Type
Procedure
Intervention Name(s)
Posterior cervical fixation surgery
Intervention Description
These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.
Primary Outcome Measure Information:
Title
Odom's criteria score at six months
Time Frame
Six months after intervention
Secondary Outcome Measure Information:
Title
Odom's criteria score at three months
Time Frame
Three months after intervention
Title
interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord
Time Frame
at six-months post-intervention
Title
Electrophysiological and grip strength
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the following: Age ≥ 18 years Patients with Hirayama disease as per the following criteria (All of the following) (16): Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion) Progressive course, or initial progression followed by stationary course; and No evidence of a compressive lesion of the spinal cord. Disease duration of ≤4 years Progression of clinical symptoms in the past six-months Exclusion Criteria: Any of the following: Refusal to consent for randomization Not willing to come for three- and six-months follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepti Vibha
Phone
+91-011-26594485
Email
deeptivibha@aiims.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kanwaljeet Garg
Phone
+91-968569905
Email
kanwaljeet@aiims.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepti Vibha
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deepti Vibha
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepti Vibha
Phone
+91-011-26594485
Email
deeptivibha@aiims.edu
First Name & Middle Initial & Last Name & Degree
Kanwaljeet Garg
First Name & Middle Initial & Last Name & Degree
Ajay Garg

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymized patient data may be shared on pertinent request

Learn more about this trial

Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study

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