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

NCT ID: NCT05959980

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-12-31

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

1. Study design:

Prospective randomized open blinded endpoint (PROBE), phase III study

2. Inclusion criteria:

All the following:

1. Age ≥ 18 years

2. Patients with Hirayama disease as per the following criteria (All of the following) (16):

1. 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)

2. Progressive course, or initial progression followed by stationary course; and

3. No evidence of a compressive lesion of the spinal cord.

3. Disease duration of ≤4 years

4. 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:

1. 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

2. 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.

3. 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.

Conditions

Hirayama Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical arm

Will undergo posterior cervical fixation surgery within 4 weeks of randomization

Group Type: EXPERIMENTAL

Posterior cervical fixation surgery

Intervention Type: PROCEDURE

These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.

Cervical collar arm

Will be given cervical collar for regular use

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Posterior cervical fixation surgery

These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All the following:

1. Age ≥ 18 years

2. Patients with Hirayama disease as per the following criteria (All of the following) (16):

1. 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)

2. Progressive course, or initial progression followed by stationary course; and

3. No evidence of a compressive lesion of the spinal cord.

3. Disease duration of ≤4 years

4. Progression of clinical symptoms in the past six-months

Exclusion Criteria

• Any of the following:

1. Refusal to consent for randomization

2. Not willing to come for three- and six-months follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Deepti Vibha

Professor, Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepti Vibha

Role: PRINCIPAL_INVESTIGATOR

AIIMS, New Delhi

Locations

Deepti Vibha

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Deepti Vibha

Role: CONTACT

deeptivibha@aiims.edu

+91-011-26594485

Kanwaljeet Garg

Role: CONTACT

kanwaljeet@aiims.edu

+91-968569905

Facility Contacts

Deepti Vibha

Role: primary

deeptivibha@aiims.edu

+91-011-26594485

Other Identifiers

AC-60

Identifier Type: -

Identifier Source: org_study_id