Health Condition 1: G238- Other specified degenerative diseases of basal ganglia
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Ramaiah Medical College and Hospitals Ramaiah University of Applied Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Orthostatic Tremor 10-item (OT-10) scale score — a validated measure of tremor severity and standing-related functional impairment.Timepoint: OT-10 scores will be recorded at baseline, 6 months, and annually at Years 1, 2, 3, 4 and 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QoL) Timepoint: Baseline, 6 months, annually at Years 1 to 5;Fall FrequencyTimepoint: Recorded continuously & summarised at 6 months & annually at Years 1 to 5;Signs & SymptomsTimepoint: Baseline, 6 months, & annually at Years 1 to 5;EMG Burst Frequency & RegularityTimepoint: Baseline & annually where available (up to Year 5);Electrophysiological ClassificationTimepoint: Baseline & annually up to Year 5;Diagnostic ReclassificationTimepoint: At each follow-up visit (6 months & annually up to Year 5);LCA-Derived SubtypesTimepoint: Derived from data collected at baseline, 6 months, & each annual visit (Years 1–5);LCA Class-Specific TrajectoriesTimepoint: Analysed from longitudinal data collected at baseline, 6 months, & annually at Years 1–5;Treatment Response RateTimepoint: Baseline & each follow-up visit (6 months & annually to Year 5);Predictors of Treatment ResponseTimepoint: Baseline, 6 months, & annually at Years 1 to 5;Time to Clinical Improvement or DeteriorationTimepoint: Continuously monitored during follow-up; summarised at 6 months & annually at Years 1 to 5;Adverse EventsTimepoint: Recorded at every follow-up visit (6 months & annually at Years 1 to 5);Neuroimaging CorrelatesTimepoint: Baseline (where available) & annually up to Year 5;Presence of Movement Disorder-Associated VariantsTimepoint: Baseline genetic sampling & once during follow-up (Year 3–5 as applicable);Genotype-Phenotype CorrelationsTimepoint: Analysed from data collected at baseline & final follow-up (Year 5);Genetics & Treatment ResponseTimepoint: Baseline genotyping correlated with treatment outcomes at Years 1–5;Oscillator Type Classification (Central vs Peripheral vs Mixed)Timepoint: Baseline & annually where electrophysiological data are available (up to Year 5);Imaging Correlates of Oscillator TypeTimepoint: Baseline & annually where imaging data are available (up to Year 5);Oscillator Class & LCA Subtype ConcordanceTimepoint: Derived from integrated datasets collec | — |
Countries
India, United States of America
Contacts
Public ContactDr Anish Mehta
Ramaiah Medical College and Hospitals, Ramaiah University of Applied Sciences
Outcome results
None listed