| CTRI Number |
CTRI/2026/02/104000 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Clinical and Neurological Features in Leprosy Patients with Evaluation of Cranial Neuropathy Using Advanced MRI Techniques. |
|
Scientific Title of Study
|
Clinical profile of leprosy patient with neurological involvement and evaluation of cranial neuropathy using Advanced MRI sequences - A tertiary care centre based cross-sectional, observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma Sharma |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Science Gorakhpur |
| Address |
ROOM NO 226, Dept of Dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8627072749 |
| Fax |
|
| Email |
sushma791998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil kumar Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science Gorakhpur |
| Address |
Dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil kumar Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science Gorakhpur |
| Address |
Dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur, Kunraghat,Gorakhpur,Uttarpradesh, India Pincode-273008 |
|
|
Primary Sponsor
|
| Name |
Sushma Sharma |
| Address |
ROOM NO 513 Resident Girls hostel, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India |
| 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 SUSHMA SHARMA |
AIIMS GORAKHPUR |
ROOM NO 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH |
8627072749
sushma791998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A309||Leprosy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.All clinically confirmed cases of leprosy (as per WHO or Ridley–Jopling classification) including release from treatment.
2.Patients presenting with neurological symptoms or signs such as: Cranial nerve palsies, Peripheral neuropathy (sensory, motor, or mixed) and autonomic dysfunction.
3.Patients willing to participate and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years, and more than 60 years
2.Pregnant and lactating female
3.Patients with neuropathies attributable to other etiologies according to clinical experts (e.g., diabetes mellitus, alcoholism, nutritional deficiency, heavy metal toxicity, vasculitis).
4.Patients with contraindications to MRI (e.g., pacemaker, metallic implants, severe claustrophobia, high creatinine (1.2mg/dl).
5.Patients unwilling to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Prevalence and pattern of CNS, PNS, and ANS involvement in leprosy.
2.Identification of specific MRI signatures associated with cranial neuropathy.
3.Strength of clinical–radiological correlation.
4.Risk factors predicting cranial neuropathy (e.g., high Bacteriological index, Lepromatous Leprosy spectrum).
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
03/03/2026 |
| 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
|
Leprosy is a chronic infection caused by Mycobacterium leprae, primarily affecting the skin and peripheral nerves. Neurological involvement is the most disabling aspect, resulting from Schwann cell invasion leading to inflammation, demyelination, and axonal loss, causing sensory, motor, and autonomic dysfunction with deformities. Emerging evidence challenges the traditional view that leprosy affects only peripheral nerves, showing involvement of the central and autonomic nervous systems. MRI studies have identified CNS lesions, particularly in brainstem regions associated with cranial nerve deficits.There is existing knowlege gap regarding the full specturum of neurological involvement in leprosy. The present study seek to analyse the neurological manifestation of leprosy through clinical evaluation and MRI findings in patients of leprosy with cranial neuropathy. |