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Pathophysiology of Tremor-modulating Mechanisms of Propranolol and Primidone in Essential Tremor

NCT04692844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2023-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Propranolol

Patients will receive Propranolol in the course of their routine treatment. Results will be used to explore biological phenomena or disease processes.

DRUG

Primidone

Patients will receive Primidone in the course of their routine treatment. Results will be used to explore biological phenomena or disease processes.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04692844 on ClinicalTrials.gov