| CTRI Number |
CTRI/2026/04/107761 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of pupillary responses and heart rate variability to detect autonomic nervous system problems in patients with craniovertebral junction and upper cervical spine disorders |
|
Scientific Title of Study
|
Correlation of Automated Pupillometry with Heart Rate Variability for Autonomic Dysfunction Assessment in Craniovertebral Junction and Upper Cervical Spine Pathologies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jerome Kumar R |
| Designation |
Senior Resident, DM Neuroanesthesia |
| Affiliation |
GB Pant Institute of Postgraduate Medical Education and Research (GIPMER) |
| Address |
Department of Anesthesiology and Intensive care - Neuroanesthesia unit, 6th floor, Academic block, GB Pant Institute of Postgraduate Medical Education and Research (GIPMER)
New Delhi
DELHI
110002
India |
| Phone |
7402055868 |
| Fax |
|
| Email |
jeromerajs95.jk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica S Tandon |
| Designation |
Director Professor and Head of Department |
| Affiliation |
GB Pant Institute of Postgraduate Medical Education and Research (GIPMER) |
| Address |
Department of Anesthesiology and Intensive care - Neuroanesthesia unit, 6th floor, Academic block, GB Pant Institute of Postgraduate Medical Education and Research (GIPMER)
New Delhi
DELHI
110002
India |
| Phone |
9718599408 |
| Fax |
|
| Email |
monicastandon@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica S Tandon |
| Designation |
Director Professor and Head of Department |
| Affiliation |
GB Pant Institute of Postgraduate Medical Education and Research (GIPMER) |
| Address |
Department of Anesthesiology and Intensive care - Neuroanesthesia unit, 6th floor, Academic block, GB Pant Institute of Postgraduate Medical Education and Research (GIPMER)
New Delhi
DELHI
110002
India |
| Phone |
9718599408 |
| Fax |
|
| Email |
monicastandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| GB Pant Institute of Postgraduate Medical Education and Research (GIPMER), New Delhi-110002, India. |
|
|
Primary Sponsor
|
| Name |
Dr Monica S Tandon |
| Address |
Department of Anesthesiology and Intensive care - Neuroanesthesia unit, 6th floor, Academic block, GB Pant Institute of Postgraduate Medical Education and Research (GIPMER), New delhi-110002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jerome Kumar R |
GB Pant Institute of Postgraduate Medical Education and Research (GIPMER) |
Neurosurgery ward, 1st floor, A block, GB Pant Institute of Postgraduate Medical Education and Research (GIPMER)
New Delhi
DELHI |
7402055868
jeromerajs95.jk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Control group |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with radiologically confirmed craniovertebral junction (CVJ) or upper
cervical spine pathology (e.g., atlantoaxial instability, basilar invagination, Chiari malformation, occipital assimilation, traumatic/degenerative cervical cord compression) |
|
| ExclusionCriteria |
| Details |
1) Ocular pathology affecting pupillary reflex (acute anisocoria, severe cataract, acute glaucoma, recent ocular surgery/trauma)
2) Major cardiac arrhythmias or pacemaker rhythm
3) Chronic systemic illnesses significantly altering autonomic function, including, chronic
kidney disease, advanced heart disease/heart failure, diabetes with autonomic neuropathy, severe hypothyroidism, Parkinsonism, known primary dysautonomia
4) Medications strongly altering pupils/autonomics within 24–48h: sympathomimetics/adrenergic agonists or antagonists, Beta-blockers, anticholinergics,
opioids/sedatives/benzodiazepines, vasoactive agents, mydriatic/miotic eye drops
5) Raised intracranial pressure, poor neurological status, agitation or inability to cooperate
6) Patients with severe disease who might not tolerate transfer to the testing facility
7) ICU admission/ventilation, sepsis, pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation coefficient of Maximum pupillary constriction velocity (Vmax) with HF power (parasympathetic/vagal activity) and Maximum pupillary dilation velocity (Vmax2) and LF/HF ratio (sympatho-vagal balance) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation coefficients for QPi, latency, T50, baseline pupil diameter vs SDNN, RMSSD, LF |
Baseline |
| Diagnostic Agreement (AP vs HRV) |
Baseline |
| Diagnostic Accuracy of AP vs HRV |
Baseline |
| Correlation with clinical & radiological disease severity |
Baseline |
| Feasibility Metrics |
Baseline |
| Healthy Reference Cohort Outcomes |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective observational study aims to evaluate the relationship between automated pupillometry parameters and heart rate variability (HRV) indices for assessing autonomic dysfunction in patients with craniovertebral junction and upper cervical spine pathologies. Structural abnormalities at the cervicomedullary junction can disrupt autonomic pathways, leading to subclinical dysautonomia and perioperative hemodynamic instability. Heart rate variability is a well-established method for evaluating autonomic function but requires ECG analysis and specialized software. Automated pupillometry is a rapid, non-invasive bedside technique that measures dynamic pupillary responses reflecting autonomic activity. The study will evaluate the correlation between pupillometry-derived parameters and HRV indices to determine whether pupillometry can serve as a reliable bedside screening tool for autonomic dysfunction in this patient population. |