| CTRI Number |
CTRI/2025/12/098825 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Wearable Device to Measure Tremors in Parkinsonism patients |
|
Scientific Title of Study
|
Wearable device to assess tremors in Parkinsonism Patients |
| 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 GOWTHAM GANAPATHY |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical
College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai TAMIL NADU 602105 India |
| Phone |
9677769775 |
| Fax |
|
| Email |
Gotham431@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MAHENDRAN K |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical
College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai TAMIL NADU 602105 India |
| Phone |
9444148005 |
| Fax |
|
| Email |
mahension@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR GOWTHAM GANAPATHY |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical
College and Hospital, Saveetha Nagar, Thandalam, Chennai
TAMIL NADU 602105 India |
| Phone |
9677769775 |
| Fax |
|
| Email |
Gotham431@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105,
Chennai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai- 602105,
Chennai, Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
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 GOWTHAM GANAPATHY |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
Department of General Medicine, Saveetha Medical
College and Hospital, Saveetha Nagar, Thandalam, Chennai Chennai TAMIL NADU |
9677769775
Gotham431@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinically diagnosed Parkinsonism idiopathic Parkinsons disease or other Parkinsonian syndromes
2 Presence of rest postural or action tremor on clinical examination
3 Able to undergo wearable device recording and UPDRS assessment during the study visit
4 Able to provide informed consent |
|
| ExclusionCriteria |
| Details |
1 Presence of other movement disorders that may interfere with tremor assessment such as severe chorea dystonia with prominent irregular movements essential tremor without Parkinsonism
2 Patients with implanted electronic devices that may interfere with sensor function such as deep brain stimulator not in stable mode
3 Severe cognitive impairment or inability to follow instructions
4 Acute medical illness preventing participation
5 Dermatological or musculoskeletal conditions that preclude safe placement of wearable sensors
6 Inability or unwillingness to participate in followup for secondary outcomes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Agreement between wearable sensor tremor metric and clinician-rated MDS-UPDRS tremor score (rest/postural/kinetic). |
Day 1, day 30,day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exploratory — effect on medication titration as informed by monitoring (if applicable) |
Day 1, day 30, day 90 |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
16/12/2025 |
| 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="6" 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
|
Assessment of Tremors in Parkinsonism Patients Using a Wearable Sensor Device is a prospective observational single arm cross sectional validation study with longitudinal follow up. The study aims to validate wearable sensor tremor measurements against clinician rated MDS UPDRS tremor scores and to evaluate the reliability, responsiveness, and feasibility of device derived metrics over time. Primary assessment will be agreement between device metrics and clinical scores at Day 1, Day 30, and Day 90. Secondary assessments include responsiveness to medication changes, test retest reliability, feasibility of device use, diagnostic accuracy, and stability of tremor burden. The study includes adults aged 18 to 80 years with clinically diagnosed Parkinsonism and detectable tremor, and excludes those with interfering movement disorders, implanted devices, severe cognitive impairment, unstable illness, or inability to attend follow up visits. A total of 80 participants will be enrolled with an expected 60 completing the Day 90 visit. Total duration is approximately nine to eleven months.
|