| CTRI Number |
CTRI/2024/06/068650 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to detect a link between duration of illness and Cognitive decline in patients with Parkinson’s disease. |
|
Scientific Title of Study
|
A Clinical Profile of Parkinsons disease and association of disease duration with cognitive impairment. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shlok Bharadwaj |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Medicine, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8005908821 |
| Fax |
|
| Email |
bharadwaj.shlok@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shubha Seshadri |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Medicine, Kasturba Medical College, MAHE, Madhav Nagar, Manipal, Udupi, Karnataka, India
Udupi KARNATAKA 576104 India |
| Phone |
8202922129 |
| Fax |
|
| Email |
shubhamanipal@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Shlok Bharadwaj |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Medicine, Kasturba Medical College, Manipal
KARNATAKA 576104 India |
| Phone |
8005908821 |
| Fax |
|
| Email |
bharadwaj.shlok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, MAHE, Madhav Nagar, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Shlok Bharadwaj |
| Address |
Department of Medicine, Kasturba Medical College, Manipal, Udupi, 576104 |
| 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 Shlok Bharadwaj |
Kasturba Hospital, Manipal |
Department of Medicine and Department of Neurology, Kasturba Medical College, Madhav Nagar, Manipal 576104 Udupi KARNATAKA |
8005908821
bharadwaj.shlok@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: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted to Kasturba Hospital and coming to neurology or medicine OPD with PD fulfilling the UKPDS Brain Bank Criteria will be included.
Included patients should be able to read English, or Kannada.
18 years of age and above. |
|
| ExclusionCriteria |
| Details |
Patients unable to read or write.
The patient admitted to KH with acute neurological or neuropsychiatric illness.
The patient is also having other underlying condition known to cause cognitive impairment: -
1. Hypothyroidism
2. Chronic kidney disease
3. Chronic liver disease
Patients excluded by UKPDS Brain Bank Criteria: -
1. History of Cerebrovascular Disease
2. History of significant Head injury
3. Previous encephalitis
4. Drug or alcohol abuse
5. Features of Parkinsonism plus syndromes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between SCOPA COG score and time since disease diagnosis in patients with PD |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to make a clinical profile of PD patients visiting tertiary care centre in south india |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
24/06/2024 |
| 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="0" Months="10" 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
|
Parkinson’s disease is one of the most common neurodegenerative diseases. Cognitive dysfunction and dementia are common in Parkinson’s disease, and the presence of dementia appears to be an independent predictor of mortality in PD. There is a distinct Lack of studies on cognitive impairment in PD patients from India. Along with the highly variable clinical course and progression of disease and dementia, the underlying pathologic and anatomical basis of dementia in PD is also poorly understood. Recognition of cognitive dysfunction early is important to improve therapeutic outcomes and prevent complications. This trial aims to describe the epidemiological and clinical characteristics of patients with Parkinson’s disease presenting to a tertiary care hospital in India with a special focus on cognitive profile with special focus on comparing cognitive impairment in groups of Parkinson’s disease patients with duration of disease. This study will help in identifying patients at risk for developing cognitive impairment as well as identifying clinical markers associated with cognitive decline in patients with PD. This would be helpful as potential for new therapeutic options to delay or prevent cognitive impairment would be best in early phase or preclinical stage of disease. |