Comparing cervical collar and surgery for Hirayama disease management
Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study
This study is testing whether wearing a cervical collar or having surgery is better for people with Hirayama disease who have seen their symptoms get worse recently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT05959980 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of cervical collar management versus posterior cervical fixation surgery in patients diagnosed with Hirayama disease who have experienced worsening symptoms in the past six months. Participants will be randomly assigned to either treatment group and will be monitored for six months to assess the outcomes. The study employs a prospective randomized open blinded endpoint (PROBE) design to ensure unbiased results. Clinical, electrophysiological, and radiological assessments will be conducted to evaluate the efficacy of both interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of Hirayama disease who have shown progressive symptoms within the last six months.
Not a fit: Patients who have not experienced symptom progression in the past six months or those unwilling to participate in follow-up assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective management strategy for patients with Hirayama disease, potentially improving their quality of life.
How similar studies have performed: While there may be limited studies specifically addressing Hirayama disease, similar approaches in managing progressive neurological conditions have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Deepti Vibha — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Principal investigator: Deepti Vibha — All India Institute of Medical Sciences
- Study coordinator: Deepti Vibha
- Email: deeptivibha@aiims.edu
- Phone: +91-011-26594485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.