| CTRI Number |
CTRI/2026/01/100831 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Symptoms, signs and different types of electrophysiological changes in patients with guillain barre syndrome correlation among different types of varies subtypes ,and in patient with with critically ill GBS and correlate with Hughes disability scores.
|
|
Scientific Title of Study
|
CLINICOELECTROPHYSIOLOGICAL PATTERNS IN GUILLAIN BARRE SYNDROME |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananta Sai Durga Prasad Mylavarapu |
| Designation |
Senior resident |
| Affiliation |
Kasturba medical college , MAHE, Manipal |
| Address |
Room no 11 , Department of neurology, Kasturba medical college , MAHE, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
9676109182 |
| Fax |
|
| Email |
masdprasad11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aparna R Pai |
| Designation |
Professor of neurology |
| Affiliation |
Kasturba medical college , MAHE, Manipal |
| Address |
Room no 11 , Department of neurology, Kasturba medical college , MAHE, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
9880182224 |
| Fax |
|
| Email |
aprpai@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Arjun chandrashekar |
| Designation |
Assistant professor of neurology |
| Affiliation |
Kasturba medical college , MAHE, Manipal |
| Address |
Room no 11 , Department of neurology, Kasturba medical college , MAHE, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
7975824327 |
| Fax |
|
| Email |
arjuhims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of neurology Kasturba medical college, Manipal, Udupi, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
Department of neurology Kasturba medical college, Manipal, Udupi, Karnataka, 576104. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ananta Sai Durga Prasad Mylavarapu |
Kasturba medical college |
Department of neurology Kasturba medical college, Manipal, Udupi, Karnataka, 576104 Udupi KARNATAKA |
9676109182
masdprasad11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2.Patients who were diagnosed as Guillain-Barre syndrome based on clinical,csf,electrophysiological criteria.
3.Patients with respiratory failure and severe weakness
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 year.
2.Pregnant females
3.Other causes of flaccid paralysis
a.Periodic paralysis
b.Renal tubular acidosis
c.Acute transverse myelitis
d.Vasculitis
e.Rabies
f.Polio and non polio enterovirus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MRC sum score and Hughes disability scores were used as outcome measures. |
at base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
22/01/2026 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Guillain-Barré syndrome (GBS) is an
acute, immune-mediated polyradiculoneuropathy characterized by rapidly
progressive weakness and varying degrees of sensory and autonomic dysfunction.
While its clinical features are well recognized, substantial heterogeneity
exists in presentation, disease severity, and electrophysiological patterns
across populations. Electrodiagnostic studies remain a cornerstone for
confirming diagnosis, distinguishing between demyelinating and axonal subtypes,
and predicting prognosis.
However, early-stage abnormalities may
be subtle or incomplete, leading to diagnostic uncertainty. Previous studies have described diverse
conduction abnormalities, including conduction block, prolonged distal
latencies, and the “sural-sparing” sensory pattern, with differing prevalence
between subtypes and disease stages.
Moreover, regional data on
clinico-electrophysiological correlations are limited, and existing
electrodiagnostic criteria may not fully capture early or mixed presentations,
necessitating context-specific evaluation. |