Hirayama DiseaseNCT05959980
Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study
A study testing Posterior cervical fixation surgery in people with Hirayama Disease, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hirayama Disease
- What is being tested?
- Posterior cervical fixation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any of the following:
- Refusal to consent for randomization
- Not willing to come for three- and six-months follow-up
Trial locations and contacts
1 site in 1 country.
About this 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
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
Read the 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:
- 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.
- Conditions
- Hirayama Disease
- Being tested
- Posterior cervical fixation surgery
- Keywords
- Hirayama disease, cervical collar, posterior cervical fixation surgery
- Medical subject headings
- Amyotrophy, monomelic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior cervical fixation surgeryProcedure or surgery
These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Surgical arm | Experimental | Will undergo posterior cervical fixation surgery within 4 weeks of randomization Receives: Procedure: Posterior cervical fixation surgery |
| Cervical collar arm | No intervention | Will be given cervical collar for regular use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odom's criteria score at six months
Measured: Six months after intervention
Secondary outcomes (3)
Odom's criteria score at three months
Measured: Three months after intervention
interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord
Measured: at six-months post-intervention
Electrophysiological and grip strength
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirayama DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepti Vibha, All India Institute of Medical Sciences
- Investigators
- Deepti Vibha, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959980
- Sponsor's protocol ID
- AC-60
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized patient data may be shared on pertinent request
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study
- ClinicalTrials.gov ID
- NCT05959980
- Acronym / sponsor ID
- AC-60
- Conditions
- Hirayama Disease
- Keywords
- Hirayama disease, cervical collar, posterior cervical fixation surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jul 2023 (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 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical arm | Experimental | Procedure: Posterior cervical fixation surgeryWill undergo posterior cervical fixation surgery within 4 weeks of randomization |
| Cervical collar arm | No intervention | –Will be given cervical collar for regular use |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- All the following:
Key exclusion criteria (3 listed)
- Any of the following:
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 |
|---|---|---|
| Posterior cervical fixation surgeryThese patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia. | Procedure or surgery | Surgical arm |
Primary outcome
Odom's criteria score at six months
Time frame: Six months after intervention
3 secondary outcomes
Odom's criteria score at three months
Time frame: Three months after intervention
interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord
Time frame: at six-months post-intervention
Electrophysiological and grip strength
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided. Anonymized patient data may be shared on pertinent request
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.
Deepti Vibha principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior cervical fixation surgery in people with Hirayama Disease, run by All India Institute of Medical Sciences at 1 site in India.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odom's criteria score at six months (time frame: Six months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.