| CTRI Number |
CTRI/2025/10/096248 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A 5-year follow-up study to learn how leg shaking while standing (orthostatic tremor and orthostatic myoclonus) affects daily life and treatment response. |
|
Scientific Title of Study
|
Study of prevalence, clinical, electrophysiological characteristics, treatment response
and quality of life in Orthostatic tremors/myoclonus- A longitudinal follow up study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anish Mehta |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences |
| Address |
Department of Neurology
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences
Bengaluru, India
Bangalore
KARNATAKA
560054
India |
| Phone |
9663788886 |
| Fax |
|
| Email |
anishmehta1302@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anish Mehta |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences |
| Address |
Department of Neurology
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences
Bengaluru, India
Email: anishmehta1302@gmail.com
Bangalore
KARNATAKA
560054
India |
| Phone |
9663788886 |
| Fax |
|
| Email |
anishmehta1302@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anish Mehta |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences |
| Address |
Department of Neurology
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences
Bengaluru, India
Bangalore
KARNATAKA
560054
India |
| Phone |
9663788886 |
| Fax |
|
| Email |
anishmehta1302@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences |
|
|
Primary Sponsor
|
| Name |
Ramaiah Medical College and Hospitals Ramaiah University of Applied Sciences |
| Address |
Department of Neurology, Ramaiah Medical College and Hospitals, M S Ramaiah Nagar, Bengaluru 560054, Karnataka, India. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
United States of America
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anish Mehta |
MS Ramaiah Medical college |
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences,
Bengaluru, India,
Bangalore
KARNATAKA |
09663788886
anishmehta1302@gmail.com |
| Dr Anish Mehta |
NIMHANS |
NIMHANS Bangalore
Bangalore
KARNATAKA |
09663788886
anishmehta1302@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G238||Other specified degenerative diseases of basal ganglia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 80 years
Male and female patients from all participating centers with a confirmed diagnosis of Orthostatic Tremor (OT) based on clinical and EMG findings
Willingness to participate and provide written informed consent
Ability to comply with study assessments and follow-up visits
|
|
| ExclusionCriteria |
| Details |
Major psychiatric disorders that interfere with assessments
Uncontrolled cardiovascular, metabolic, or systemic diseases
Co-existing neurological disorders (e.g., Parkinson’s disease, peripheral neuropathy)
Pregnant or lactating women
Inability to provide informed consent or adhere to follow-up protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Orthostatic Tremor 10-item (OT-10) scale score — a validated measure of tremor severity and standing-related functional impairment. |
OT-10 scores will be recorded at baseline, 6 months, and annually at Years 1, 2, 3, 4 and 5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life (QoL)
|
Baseline, 6 months, annually at Years 1 to 5 |
| Fall Frequency |
Recorded continuously & summarised at 6 months & annually at Years 1 to 5 |
| Signs & Symptoms |
Baseline, 6 months, & annually at Years 1 to 5 |
| EMG Burst Frequency & Regularity |
Baseline & annually where available (up to Year 5) |
| Electrophysiological Classification |
Baseline & annually up to Year 5 |
| Diagnostic Reclassification |
At each follow-up visit (6 months & annually up to Year 5) |
| LCA-Derived Subtypes |
Derived from data collected at baseline, 6 months, & each annual visit (Years 1–5) |
| LCA Class-Specific Trajectories |
Analysed from longitudinal data collected at baseline, 6 months, & annually at Years 1–5 |
| Treatment Response Rate |
Baseline & each follow-up visit (6 months & annually to Year 5) |
| Predictors of Treatment Response |
Baseline, 6 months, & annually at Years 1 to 5 |
| Time to Clinical Improvement or Deterioration |
Continuously monitored during follow-up; summarised at 6 months & annually at Years 1 to 5 |
| Adverse Events |
Recorded at every follow-up visit (6 months & annually at Years 1 to 5) |
| Neuroimaging Correlates |
Baseline (where available) & annually up to Year 5 |
| Presence of Movement Disorder-Associated Variants |
Baseline genetic sampling & once during follow-up (Year 3–5 as applicable) |
| Genotype-Phenotype Correlations |
Analysed from data collected at baseline & final follow-up (Year 5) |
| Genetics & Treatment Response |
Baseline genotyping correlated with treatment outcomes at Years 1–5 |
| Oscillator Type Classification (Central vs Peripheral vs Mixed) |
Baseline & annually where electrophysiological data are available (up to Year 5) |
| Imaging Correlates of Oscillator Type |
Baseline & annually where imaging data are available (up to Year 5) |
| Oscillator Class & LCA Subtype Concordance |
Derived from integrated datasets collected at baseline, 6 months, & annually at Years 1–5 |
| Oscillator Type & Treatment Response |
Baseline & each follow-up visit (6 months & annually up to Year 5) |
| Patient Global Impression of Change (PGIC) |
Baseline, 6 months, & annually at Years 1–5 |
| Caregiver Burden Score |
Baseline, 6 months, & annually at Years 1–5 |
| Wearable-Based Tremor & Gait Monitoring |
Baseline pilot measurement & annually where available (up to Year 5) |
| Cost of Illness Assessment |
Baseline & annually up to Year 5 |
| Bayesian Modeling of Latent Class Transitions |
Modelled using data obtained at baseline, 6 months, & annually up to Year 5 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
LOTS is a multi-centre, prospective cohort study that builds
upon an initial cohort of 58 retrospectively characterised patients identified
at a tertiary care centre in India. Additional incident cases will be recruited
across national and international sites during a two-year enrolment window.
Participants will undergo assessments at baseline, 6 months, and annually for
five years. Primary outcomes include the OT-10 scale and a novel Disease Burden
Score (DBS). Secondary outcomes encompass quality of life, functional capacity,
and treatment response. Exploratory analyses will include neurophysiology,
imaging, and biomarker data where available. Latent Class Analysis (LCA) will
identify subgroups with distinct trajectories, while mixed-effects models will assess
longitudinal changes and multivariable regression will identify predictors of
progression and treatment response. Potential limitations include attrition
during long-term follow-up and variability in access to specialised
electrophysiological assessments across centres. |