| CTRI Number |
CTRI/2020/01/023075 [Registered on: 31/01/2020] Trial Registered Prospectively |
| Last Modified On: |
11/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop an automatic system for Parkinson’s disease diagnosis, disease staging and response to treatment from handwriting and free-hand drawing analysis |
|
Scientific Title of Study
|
Establishing correlation of progressive neurological disorders (Parkinson Disease, Essential Tremor, Writers Cramp)with hand-drawn pattern and tracking therapeutic response using machine learning techniques |
| Trial Acronym |
AID-PD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N.A. |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jija Das Gupta |
| Designation |
SERB, National Postdoctoral Fellow |
| Affiliation |
Electronics and communication science unit |
| Address |
Indian Statistical Institute,
Plot No, 203, BT Rd,
Dunlop, Bonhooghly Government
Colony,
Baranagar, Kolkata,
West Bengal 700108
Kolkata
WEST BENGAL
700108
India |
| Phone |
9903353778 |
| Fax |
|
| Email |
jijadasgupta@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jija Das Gupta |
| Designation |
SERB, National Postdoctoral Fellow |
| Affiliation |
Indian Statistical Institute |
| Address |
Indian Statistical Institute,
Plot No, 203, BT Rd,
Dunlop, Bonhooghly Government
Colony,
Baranagar, Kolkata,
West Bengal 700108
Kolkata
WEST BENGAL
700108
India |
| Phone |
9903353778 |
| Fax |
|
| Email |
jijadasgupta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jija Das Gupta |
| Designation |
SERB, National Postdoctoral Fellow |
| Affiliation |
Electronics and communication science unit |
| Address |
Indian Statistical Institute,
Plot No, 203, BT Rd,
Dunlop, Bonhooghly Government
Colony,
Baranagar, Kolkata,
West Bengal 700108
Kolkata
WEST BENGAL
700108
India |
| Phone |
9903353778 |
| Fax |
|
| Email |
jijadasgupta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Science and Engineering Research Board,
5 & 5A, Lower Ground Floor
Vasant Square Mall
Sector-B, Pocket-5
Vasant Kunj
New Delhi – 110 070
|
|
|
Primary Sponsor
|
| Name |
Science and Engineering Research Board |
| Address |
5 & 5A, Lower Ground Floor
Vasant Square Mall
Sector-B, Pocket-5
Vasant Kunj
New Delhi – 110 070 |
| Type of Sponsor |
Government funding agency |
|
|
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 Jija Das Gupta |
Bangur Institute of Neuroscience, |
Department of Neuromedicine,
Bangur Institute of Neuroscience,
Institute of Postgraduate Medical Education and Research,
Kolkata-700020,
India.
Kolkata
WEST BENGAL |
9903353778
jijadasgupta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of IPGME&R, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers having no neurological disorder |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (2) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
a. Study group
Adult males or females with diagnosis of Parkinson’s Disease, Essential Tremor, Writer’s Cramp.
b. Control group
Adult males or females who has no neurological problem.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Ill literate person, cannot read or write English and or Bengali, left handed person
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Off-line hand writing/drawing database of persons suffering from Parkinson’s Disease, Essential Tremor and Writer’s Cramp
An automatic system for Parkinson’s Disease diagnosis, staging and tracking of therapeutic response.
|
at first point or time of contact |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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)
|
03/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/02/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- A comparative observational study to develop an automatic system for diagnosing, staging and tracking therapeutic response of Parkinson’s Disease patients by analyzing their handwriting using Artificial Intelligence (AI) techniques. Some handcrafted and machine generated features will be studied and feature vectors will be classified using suitable classifiers such as MLP, SVM, HMM, DCNN etc. A Database for training as well as evaluating the system will be developed by collecting handwriting of persons suffering from Parkinson’s Disease and similar disorders like Essential Tremor, Writer’s Cramp with doctor’s comments. Handwriting and drawing samples of healthy persons will also be collected as control group.
- Expected Output: Using Artificial Intelligence (AI) techniques we shall develop a system where the input is a chronological sequence of patient’s handwriting and output will be whether the person is suffering from Parkinson’s Disease or not and also to comment on the stage of disease. This system can be also be used for measuring therapeutic response of Parkinson’s Disease to commonly used drugs.
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