Clinical trial

The Mechanism of Tremor Modulating Properties of Propranolol and Primidone in Essential Tremor: A Study With Transcranial Magnetic Stimulation and Eye Blink Classical Conditioning Paradigm

Name
0120-525/2017
Description
Pathophysiology of tremor-modulating mechanisms of propranolol and primidone in essential tremor (ET) will be studied using accelerometry with electromyography (EMG), transcranial magnetic stimulation (TMS), and eyeblink conditioning paradigm (EBCC). TMS is a well-established experimental method for studying the effects of drugs on motor cortex excitability. EBCC is a learning paradigm that can be used for studying cerebellar dysfunction since only brainstem and cerebellar functions seem to be needed for this paradigm. The investigators will use TMS to study the mechanisms of primidone and propranolol action in ET, EBCC paradigm to evaluate cerebellar dysfunction in ET patients and to show whether cerebellar dysfunction influences the effectiveness of propranolol and primidone. The investigators will clinically assess patients using The Essential Tremor Rating Assessment Scale (TETRAS) and the Scale for the Assessment and Rating of Ataxia (SARA) scales. Patients with ET will be studied prior to treatment with propranolol or primidone and re-tested 3-6 months after treatment initiation. On each visit, the investigators will clinically assess the patients and perform accelerometry, TMS measurements, and the eyeblink classical conditioning (EBCC) paradigm. The investigators hypothesize that in ET patients, baseline electrophysiological parameters will differ between responders and non-responders to propranolol and primidone and that propranolol and primidone will cause a different pattern of change in electrophysiological parameters among responders. It is hypothesized that cerebellar dysfunction will negatively correlate with patients' response to treatment.
Trial arms
Trial start
2017-08-28
Estimated PCD
2022-12-31
Trial end
2022-12-31
Status
Completed
Treatment
Propranolol
Patients will receive Propranolol in the course of their routine treatment. Results will be used to explore biological phenomena or disease processes.
Arms:
Patients with essential tremor treated with Propranolol
Primidone
Patients will receive Primidone in the course of their routine treatment. Results will be used to explore biological phenomena or disease processes.
Arms:
Patients with essential tremor treated with Primidone
Size
61
Primary endpoint
Electrophysiological correlations of clinical effect
3-6 months
Effect of cerebellar function assessed by eye blink classical conditioning on drug effectiveness
3-6 months
Eligibility criteria
Inclusion Criteria: * diagnosis of essential tremor made according to the newest consensus statement on the classification of tremors * patients initiated on propranolol or primidone Exclusion Criteria: * a history of seizures * a history of mental illness, * having a cardiac pacemaker * having metal material in the head (except dental material in the mouth) * having a medication pump * pregnancy
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}
Updated at
2023-04-13

1 organization

2 products

1 indication

Product
Primidone