Comparison of Surgery versus cervical collar treatment in Hirayama Disease (a medical condition with weakness and wasting of arms and/or hands)

Posterior cervical fixation versus long-term cervical collar for management of Hirayama Disease: Prospective randomized open blinded endpoint (PROBE), phase III study - -

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056849

Enrollment

Registered

2023-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G128- Other spinal muscular atrophies and related syndromes

Interventions

Intervention1: Posterior cervical fixation surgery: Posterior cervical fixation surgery will be done under GA to prevent dynamic flexion ischemia in progressive disease Control Intervention1: Cervical

Eligibility

Inclusion criteria

Inclusion criteria: (1) Age = 18 years (2) Patients with Hirayama disease as per the following criteria (All of the following): a. 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) b. Progressive course, or initial progression followed by stationary course; and c. 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

Exclusion criteria: Any of the following: (1) Refusal to consent for randomization. (2) Not willing to come for three- and six-months follow-up.

Design outcomes

Primary

Measure	Time frame
1)To determine & compare the efficacy of posterior cervical fixation versus cervical collar in patients with Hirayama disease in terms of Odom’s criteria at six months after randomization.Timepoint: Six months	—

Secondary

Measure	Time frame
1) To determine & compare the efficacy of posterior cervical fixation versus cervical collar in patients with Hirayama disease in terms of Odom’s criteria at three months after randomization.Timepoint: Three months;2) To compare MRI DTI parameter in two groupsTimepoint: Six months;3) Compare clinical & electrophysiological features in two groupsTimepoint: Six months	—

Countries

India

Contacts

Public ContactDeepti Vibha

All India Institute of Medical Sciences

deeptivibha@aiims.edu011-26594485

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026