Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06821906

Stereotactic Radiosurgery in the Treatment of Essential Tremor

The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Gliwice, 44-101, Poland

Location status: Recruiting

Location contact

Aleksandra Napieralska

CONTACT

[email protected]

48322788056

About this study

The study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. The study will include patients who have been disqualified from the Deeply Brain Stimulation procedure or who do not consent to its performance. Additional conditions for the examination are age over 50 and the duration of the disease over 5 years.

After qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms:

  • control arm: patients irradiated with the CyberKnife with a dose of 130 Gy
  • test arm: patients irradiated with the CyberKnife with a dose of 80 Gy

The primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Essential tremor diagnosed, Parkinson's disease and other causes of tremor excluded.
  • Insufficient tremor control despite the use of available pharmacotherapy methods.
  • Disqualification from the Deeply Brain Stimualtion procedure/lack of consent to perform it on the side qualified for Stereotactic Radiosurgery
  • Consent to participate in a clinical trial.

Exclusion criteria

  • Age under 50
  • Pregnancy
  • Duration of the disease less than 5 years
  • Dementia, psychosis or other condition that prevents giving informed consent to participate in the study
  • Poor general condition, serious comorbidities
  • Structural changes in the basal ganglia or major atrophic changes
  • Previous radiotherapy to the brain covering the potential treatment area
  • Medical contraindications to magnetic resonance imaging

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy

Primary outcomes

  1. Treatment Efficacy

    Time frame: 24 months

    Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)

Secondary outcomes

  1. Quality of life

    Time frame: 24 months

    The impact of treatment on the quality of life of patients based on the dedicated Quality of Life in Essential Tremor questionnaire

  2. Safety

    Time frame: 24 months

    Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Szczyrba

CONTACT

[email protected]

48322788001

Aleksandra Napieralska

CONTACT

[email protected]

48322788056

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Official study title

Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study

Acronym: EASIER

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.