Health Condition 1: G328- Other specified degenerative disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Oral Propranolol Hydrochloride ER: The patients in intervention arm will receive oral propranolol hydrochloride starting from a dose of 40 mg. The dose will be uptitrated in increments
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: •All genetically proven SCA 12 patients with tremors. •Age 18 yrs to 65 years. •Tremor severity score of at least 2 in at least one upper extremity on at least one of the three maneuvers on the TETRAS scale.
Exclusion criteria
Exclusion criteria: 1.Patients with conditions that are absolute or relative contraindications to the use of beta blockers- a. Bronchial asthma, COPD b. Peripheral vascular disease c. Uncontrolled Diabetes Mellitus with HbA1c >10% or on insulin therapy d. Acute Heart failure e. Conduction blocks f. Bradycardia with heart rate less than 60 bpm g. Blood pressure less than 90 mm Hg systolic and 60 mm Hg diastolic. 2. All other possible causes of tremors a. Hyperthyroidism b. Idiopathic Parkinsons disease c. Drugs like beta agonists ,theophylline, valproate, lamotrigine d. Enhanced physiological tremors, based on clinician’s opinion e. Psychogenic tremors, based on clinician’s opinion 3.Not giving consent 4.Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in TETRAS PS scores and composite of TETRAS PS + ADL scores after receiving oral propranolol starting from dose of 40 mg to a maximum dose of 240 mg or the maximum tolerated dose at the end of 4 weeks and 8 weeks of stable dose. A clinically meaningful reduction in tremor will be defined as a 30% reduction in TETRAS PS score as well composite TETRAS PS + ADL score from the baseline. Timepoint: At the end of 4 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. At the end of 8 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the change in ataxia severity using SARA scores after receiving oral propranolol starting from dose of 40 mg to a maximum dose of 240 mg or the maximum tolerated dose at the end of 4 weeks and 8 weeks of stable dose.Timepoint: At the end of 4 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. At the end of 8 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol.;2) To assess the change in health related quality of life using SF 36 questionairre after receiving oral propranolol starting from dose of 40 mg to a maximum dose of 240 mg or the maximum tolerated dose at the end of 4 weeks and 8 weeks of stable dose.Timepoint: At the end of 4 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. At the end of 8 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol.;3) To assess the change in quantitative assessment of tremor severity, frequency and characteristics using surface EMG and accelometry after receiving oral propranolol starting from dose of 40 mg to a maximum dose of 240 mg or the maximum tolerated dose at the end of 8 weeks of stable dose.Timepoint: At the end of 4 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. At the end of 8 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. | — |
Countries
India
Contacts
Public ContactDr Prachi Mohapatra
AIIMS New Delhi
Outcome results
None listed